Treatment algorithm

Please note that formulations/routes and doses may differ between drug names and brands, drug formularies, or locations. Treatment recommendations are specific to patient groups: see disclaimer

ACUTE

initial episode: non-severe

1st line – oral fidaxomicin or vancomycin or metronidazole

Back
ACUTE
|
initial episode: non-severe
1st line – 

oral fidaxomicin or vancomycin or metronidazole

Supportive clinical data: leukocytosis with WBC count of ≤15,000 cells/mL and serum creatinine <0.13 mmol/L (<1.5 mg/dL).

Antibiotic therapy should be started empirically if there is likely to be a substantial delay (>48 hours) in laboratory confirmation. For other patients, antibiotic therapy may be started after diagnosis in order to limit the overuse of antibiotics.

The Infectious Diseases Society of America/Society for Healthcare Epidemiology of America (IDSA/SHEA) recommends oral fidaxomicin as a first-line agent for an initial episode of Clostridioides difficile infection, as it is more effective than vancomycin with respect to sustained clinical response. This recommendation is based on moderate-certainty evidence. Fidaxomicin may not be widely available and is more costly; therefore, vancomycin remains an acceptable alternative.[2]​​​[74] The ACG recommends vancomycin or fidaxomicin for the treatment of an initial episode of non-severe disease.[58] Metronidazole is now only recommended in settings where access to first-line agents is limited.[2]​​​​

International guidelines may recommend different treatments and local guidance should be consulted. In the UK, the National Institute for Health and Care Excellence recommends vancomycin for an initial episode, regardless of disease severity, on the basis of cost effectiveness. Fidaxomicin is considered a second-line agent.[78] In Europe, the European Society of Clinical Microbiology and Infectious Diseases recommends fidaxomicin as the preferred standard of care treatment for an initial episode, with vancomycin considered an alternative option. Fidaxomicin is the preferred agent in those at high risk of recurrence. Metronidazole is only recommended if the preferred options are not available.[79]

Highest quality evidence indicates fidaxomicin is significantly better than vancomycin at achieving sustained symptomatic cure in adults with non-multiply recurrent infections. It is therefore considered a better treatment option than vancomycin in all patients except those with severe infections. Cure rates with metronidazole were significantly less compared to vancomycin and fidaxomicin. Furthermore, fidaxomicin is more effective at preventing recurrence compared with vancomycin.[80][81][82][83]​​​

While therapeutic drug monitoring is not usually recommended with the use of oral vancomycin, it may be considered on a case-by-case basis, particularly in high-risk situations where high blood levels are anticipated (e.g., renal impairment, inflammatory bowel disease).[87]

The recommended drug regimens detailed here are based on IDSA/SHEA guidance.[2]​​​[74]

Primary options

fidaxomicin: 200 mg orally twice daily for 10 days

Secondary options

vancomycin: 125 mg orally four times daily for 10 days

More

Tertiary options

metronidazole: 500 mg orally three times daily for 10-14 days

Plus – discontinuation of causative agent

Back
ACUTE
|
initial episode: non-severe
Plus – 

discontinuation of causative agent

Treatment recommended for ALL patients in selected patient group

At the first suggestion of diagnosis, the inciting antibiotic(s) should be discontinued as soon as possible.[2]​​​

If antibiotics cannot be withdrawn, an agent less likely to cause C difficile infection should be substituted. In particular avoid ampicillin, cephalosporins, clindamycin, carbapenems, and fluoroquinolones.

Plus – supportive care

Back
ACUTE
|
initial episode: non-severe
Plus – 

supportive care

Treatment recommended for ALL patients in selected patient group

Patients should be evaluated for fluid status initially, especially if they are hospitalised. If necessary, hydration and electrolyte replacement should be instituted.

Use of antimotility agents, including opioids and loperamide, should be avoided, although there is no evidence to support this recommendation.

Plus – infection control measures

Back
ACUTE
|
initial episode: non-severe
Plus – 

infection control measures

Treatment recommended for ALL patients in selected patient group

Patients should be isolated in a private room with a dedicated toilet. Priority should be given to patients with stool incontinence. Patients with suspected infection should be placed on contact precautions before test results become available. Contact precautions should be continued for at least 48 hours after diarrhoea has resolved, and until discharge if C difficile infection rates remain high.[2]​​​[64]

Healthcare professionals should use gowns and gloves on entry to a room. Hand hygiene should be performed before and after patient contact and after removing gloves. Either soap and water, or an alcohol-based product, should be used. Patients should also be encouraged to wash their hands and shower to reduce spore burden on the skin. Disposable patient equipment is preferred if available (rectal thermometers are not recommended).[2]​​​

The World Health Organization provides guidelines on correct hand-washing technique.[63] WHO: guidelines on hand hygiene Opens in new window

initial episode: severe

1st line – oral fidaxomicin or vancomycin

Back
ACUTE
|
initial episode: severe
1st line – 

oral fidaxomicin or vancomycin

Supportive clinical data: leukocytosis with WBC count of ≥15,000 cells/mL and serum creatinine >0.13 mmol/L (>1.5 mg/dL).

Antibiotic therapy should be started empirically if there is likely to be a substantial delay (>48 hours) in laboratory confirmation.[2]​​​

IDSA/SHEA recommends fidaxomicin as a first-line agent for an initial episode of C difficile infection, as it is more effective than vancomycin with respect to sustained clinical response. This recommendation is based on moderate-certainty evidence. Fidaxomicin may not be widely available and is more costly; therefore, vancomycin remains an acceptable alternative.[2]​​​[74] The ACG recommends vancomycin or fidaxomicin for the treatment of an initial episode of severe disease.[58]

International guidelines may recommend different treatments and local guidance should be consulted. In the UK, the National Institute for Health and Care Excellence recommends vancomycin for an initial episode, regardless of disease severity, on the basis of cost effectiveness. Fidaxomicin is considered a second-line agent.[78] In Europe, the European Society of Clinical Microbiology and Infectious Diseases recommends either fidaxomicin or vancomycin for severe infections.[79]

While therapeutic drug monitoring is not usually recommended with the use of oral vancomycin, it may be considered on a case-by-case basis, particularly in high-risk situations where high blood levels are anticipated (e.g., renal impairment, severe disease, inflammatory bowel disease).[87]

The recommended drug regimens detailed here are based on IDSA/SHEA guidance.[2]​​​[74]

Primary options

fidaxomicin: 200 mg orally twice daily for 10 days

Secondary options

vancomycin: 125 mg orally four times daily for 10 days

More

Plus – discontinuation of causative agent

Back
ACUTE
|
initial episode: severe
Plus – 

discontinuation of causative agent

Treatment recommended for ALL patients in selected patient group

At the first suggestion of diagnosis, the inciting antibiotic(s) should be discontinued as soon as possible.[2]​​​

If antibiotics cannot be withdrawn, an agent less likely to cause C difficile infection should be substituted. In particular avoid ampicillin, cephalosporins, clindamycin, carbapenems, and fluoroquinolones.

Plus – supportive care

Back
ACUTE
|
initial episode: severe
Plus – 

supportive care

Treatment recommended for ALL patients in selected patient group

Patients should be evaluated for fluid status initially, especially if they are hospitalised. If necessary, hydration and electrolyte replacement should be instituted.

Use of antimotility agents, including opioids and loperamide, should be avoided, although there is no evidence to support this recommendation.

Plus – infection control measures

Back
ACUTE
|
initial episode: severe
Plus – 

infection control measures

Treatment recommended for ALL patients in selected patient group

Patients should be isolated in a private room with a dedicated toilet. Priority should be given to patients with stool incontinence. Patients with suspected infection should be placed on contact precautions before test results become available. Contact precautions should be continued for at least 48 hours after diarrhoea has resolved, and until discharge if C difficile infection rates remain high.[2]​​​[64]

Healthcare professionals should use gowns and gloves on entry to a room. Hand hygiene should be performed before and after patient contact and after removing gloves. Either soap and water, or an alcohol-based product, should be used. Patients should also be encouraged to wash their hands and shower to reduce spore burden on the skin. Disposable patient equipment is preferred if available (rectal thermometers are not recommended).[2]​​​

The World Health Organization provides guidelines on correct hand-washing technique.[63] WHO: guidelines on hand hygiene Opens in new window

2nd line – faecal microbiota-based therapy

Back
ACUTE
|
initial episode: severe
2nd line – 

faecal microbiota-based therapy

Faecal microbiota-based therapies include conventional faecal microbiota transplantation (FMT) and live biotherapeutic products.

US guideline recommendations on conventional FMT for severe and fulminant disease vary. The ACG recommends considering conventional FMT in patients with severe and fulminant disease who are refractory to antibiotic therapy, in particular, when patients are deemed poor surgical candidates.[58] The American Gastroenterological Association (AGA) recommends conventional FMT for hospitalised patients with severe or fulminant disease who are refractory to antibiotic therapy.[77]​ However, IDSA/SHEA do not currently recommend FMT in these patients as yet.[2]​​ International guidelines may recommend different treatments and local guidance should be consulted.

While guidelines currently recommend conventional FMT as an option, in practice there is a shift towards using live biotherapeutic products (where available) in place of conventional FMT. However, guidelines do not currently recommend live biotherapeutic products for patients with severe and fulminant disease, and they are not approved for this indication.

initial episode: fulminant

1st line – vancomycin plus metronidazole, or tigecycline, or intravenous immunoglobulin (IVIG)

Back
ACUTE
|
initial episode: fulminant
1st line – 

vancomycin plus metronidazole, or tigecycline, or intravenous immunoglobulin (IVIG)

Supportive clinical data: hypotension, shock, ileus, or megacolon. Also known as severe, complicated infection.

Antibiotic therapy should be started empirically if there is likely to be a substantial delay (>48 hours) in laboratory confirmation.

Oral vancomycin (at a higher dose than the dose used for non-fulminant infection) is the recommended first-line treatment. If ileus is present, rectal installation of vancomycin can be considered. Intravenous metronidazole should be given with oral or rectal vancomycin, particularly if ileus is present as this may impair delivery of oral vancomycin to the colon.[2]​​​

In patients who are not responding to first-line therapy, tigecycline or IVIG have been used, but no controlled trials have been performed.[2]​​ IVIG has been effective in a small number of patients with fulminant disease, presumably by providing neutralising antibodies against toxins A and B.[21][22] IVIG may be considered in fulminant disease in those who have a high surgery risk; however, there are no definite data or guidelines to support this recommendation.

International guidelines may recommend different treatments and local guidance should be consulted. In the UK, the National Institute for Health and Care Excellence recommends seeking urgent specialist advice in life-threatening infection, which may include surgery. Antibiotics that specialists may offer initially are vancomycin orally (at a higher dose than is used for non-fulminant infection) with metronidazole intravenously.[78] In Europe, the European Society of Clinical Microbiology and Infectious Diseases recommends either fidaxomicin or vancomycin for severe, complicated, or refractory infections (with or without intravenous metronidazole or tigecycline).[79]

While therapeutic drug monitoring is not usually recommended with the use of oral vancomycin, it may be considered on a case-by-case basis, particularly in high-risk situations where high blood levels are anticipated (e.g., renal impairment, combination oral and enteral therapy, severe disease, inflammatory bowel disease).[87]

The recommended drug regimens detailed here are based on IDSA/SHEA guidance.[2]​​​[74]

Primary options

vancomycin: 500 mg orally (or by nasogastric tube) four times daily; or 500 mg in 100 mL of normal saline rectally (as a retention enema) every 6 hours

More

and

metronidazole: 500 mg intravenously every 8 hours

Secondary options

tigecycline: 100 mg intravenously initially as a loading dose, followed by 50 mg every 12 hours

OR

normal immunoglobulin human: 150-400 mg/kg intravenously as a single dose

Plus – discontinuation of causative agent

Back
ACUTE
|
initial episode: fulminant
Plus – 

discontinuation of causative agent

Treatment recommended for ALL patients in selected patient group

At the first suggestion of diagnosis, the inciting antibiotic(s) should be discontinued as soon as possible.[2]​​​

If antibiotics cannot be withdrawn, an agent less likely to cause C difficile infection should be substituted. In particular avoid ampicillin, cephalosporins, clindamycin, carbapenems, and fluoroquinolones.

Plus – supportive care

Back
ACUTE
|
initial episode: fulminant
Plus – 

supportive care

Treatment recommended for ALL patients in selected patient group

Patients should be evaluated for fluid status initially, especially if they are hospitalised. If necessary, hydration and electrolyte replacement should be instituted.

Use of antimotility agents, including opioids and loperamide, should be avoided, although there is no evidence to support this recommendation.

Plus – infection control measures

Back
ACUTE
|
initial episode: fulminant
Plus – 

infection control measures

Treatment recommended for ALL patients in selected patient group

Patients should be isolated in a private room with a dedicated toilet. Priority should be given to patients with stool incontinence. Patients with suspected infection should be placed on contact precautions before test results become available. Contact precautions should be continued for at least 48 hours after diarrhoea has resolved, and until discharge if C difficile infection rates remain high.[2]​​​[64]

Healthcare professionals should use gowns and gloves on entry to a room. Hand hygiene should be performed before and after patient contact and after removing gloves. Either soap and water, or an alcohol-based product, should be used. Patients should also be encouraged to wash their hands and shower to reduce spore burden on the skin. Disposable patient equipment is preferred if available (rectal thermometers are not recommended).[2]​​​

The World Health Organization provides guidelines on correct hand-washing technique.[63] WHO: guidelines on hand hygiene Opens in new window

Consider – surgery

Back
ACUTE
|
initial episode: fulminant
Consider – 

surgery

Additional treatment recommended for SOME patients in selected patient group

Early diagnosis and treatment are essential for a good outcome, and early surgical intervention should be considered in patients who are unresponsive to medical therapy or who have rising WBC count or lactate level.

The surgical procedure of choice is a subtotal colectomy with preservation of the rectum. Diverting loop ileostomy (with colonic lavage followed by antegrade vancomycin flushes) is an alternative approach.[2]​​​[92] Both procedures have similar survival rates; however, loop ileostomy is associated with a lower risk of surgical site infections, and an increased rate of colonic preservation. Evidence is limited.[93][94]​​ ​​

2nd line – faecal microbiota-based therapy

Back
ACUTE
|
initial episode: fulminant
2nd line – 

faecal microbiota-based therapy

Faecal microbiota-based therapies include conventional faecal microbiota transplantation (FMT) and live biotherapeutic products.

US guideline recommendations on conventional FMT for severe and fulminant disease vary. The ACG recommends considering conventional FMT in patients with severe and fulminant disease who are refractory to antibiotic therapy, in particular, when patients are deemed poor surgical candidates.[58] The American Gastroenterological Association (AGA) recommends conventional FMT for hospitalised patients with severe or fulminant disease who are refractory to antibiotic therapy.[77]​ However, IDSA/SHEA do not currently recommend FMT in these patients as yet.[2]​​ International guidelines may recommend different treatments and local guidance should be consulted.​

While guidelines currently recommend conventional FMT as an option, in practice there is a shift towards using live biotherapeutic products (where available) in place of conventional FMT. However, guidelines do not currently recommend live biotherapeutic products for patients with severe and fulminant disease, and they are not approved for this indication.

ONGOING

first recurrence

1st line – repeat course of antibiotic therapy

Back
ONGOING
|
first recurrence
1st line – 

repeat course of antibiotic therapy

IDSA/SHEA recommends that a first recurrence should be treated with a 10- or 20-day course of fidaxomicin first line. A prolonged tapered and pulsed-dose regimen of oral vancomycin, or a standard 10-day course of oral vancomycin (if metronidazole was used for the initial episode) are alternative options.[2]​​​[74] The ACG recommends a tapered and pulsed-dose regimen of oral vancomycin (after an initial course of fidaxomicin, vancomycin, or metronidazole) or fidaxomicin (after an initial course of vancomycin or metronidazole) for a first recurrence.[58]

Taper and pulsed-dose regimens of vancomycin were superior to taper alone and pulsed-dose alone regimens (resolution rates of 83% versus 68% and 54%, respectively) for recurrent infection. However, evidence is limited.[98]

International guidelines may recommend different treatments and local guidance should be consulted. In the UK, the National Institute for Health and Care Excellence recommends fidaxomicin as the treatment of choice for a further episode of infection within 12 weeks of symptom resolution, or vancomycin or fidaxomicin if the further episode is more than 12 weeks after symptom resolution.[78] In Europe, the European Society of Clinical Microbiology and Infectious Diseases recommends fidaxomicin for a first recurrence. Vancomycin taper and pulse is an alternative option.[79]

While therapeutic drug monitoring is not usually recommended with the use of oral vancomycin, it may be considered on a case-by-case basis, particularly in high-risk situations where high blood levels are anticipated (e.g., renal impairment, severe disease, inflammatory bowel disease).[87]

The recommended drug regimens detailed here are based on IDSA/SHEA guidance.[2]​​​[74]

Primary options

fidaxomicin: 200 mg orally twice daily for 10 days; or 200 mg orally twice daily for 5 days, followed by 200 mg on alternate days for 20 days

Secondary options

vancomycin: standard regimen: 125 mg orally four times daily for 10 days; tapered and pulsed regimen: 125 mg orally four times daily for 10-14 days, followed by 125 mg twice daily for 7 days, then 125 mg once daily for 7 days, then 125 mg every 2-3 days for 2-8 weeks

More

Consider – bezlotoxumab

Back
ONGOING
|
first recurrence
Consider – 

bezlotoxumab

Additional treatment recommended for SOME patients in selected patient group

Bezlotoxumab, a human monoclonal antibody that binds to Clostridioides difficile toxin B, has been approved to reduce the recurrence of C difficile infection in adults who are receiving antibacterial treatment for C difficile infection and who have a high risk of recurrence. It is not indicated for the treatment of C difficile infection and is not an antibacterial drug so must be used in combination with antibiotic therapy. Bezlotoxumab should be used under specialist guidance.

IDSA/SHEA recommends using bezlotoxumab alongside standard of care antibiotics for the prevention of recurrence in patients who have had a recurrent episode within the last 6 months, particularly those who are at high risk of recurrence (e.g., age ≥65 years, immunocompromised, severe disease on presentation) and provided logistics for intravenous administration is not an issue. This recommendation is based on very low certainty evidence.[74] The ACG also recommends considering bezlotoxumab for the prevention of recurrence in patients who are at high risk of recurrence.[58]

International guidelines may recommend different treatments and local guidance should be consulted. In the UK, the National Institute for Health and Care Excellence does not recommend offering bezlotoxumab to prevent recurrent infection as it is not cost effective.[78] In Europe, the European Society of Clinical Microbiology and Infectious Diseases recommends bezlotoxumab (in addition to standard of care antibiotics) for the treatment of an initial episode in those at high risk of recurrence, as a first-line option for a first recurrence, and a second line-option for a subsequent recurrence.[79]

A single intravenous dose of bezlotoxumab (given in combination with standard antibiotic treatment) for primary or recurrent C difficile infection was associated with a 38% lower rate of recurrent infection compared with antibiotic treatment alone in 2 phase III trials. Sustained cure (no recurrent infection in 12 weeks) was achieved by 64% of patients compared with 54% of patients in the placebo group. The most common adverse effects were nausea and diarrhoea, and the drug had a similar adverse effect profile to placebo.[99] Bezlotoxumab was no better at resolving recurrent infection compared with fecal microbiota transplant.[101] Data on the use of bezlotoxumab when fidaxomicin is used as the standard of care antibiotic are limited.[74] 

In patients with a history of congestive heart failure, bezlotoxumab should be reserved for use when the benefits outweigh the risks. Heart failure was reported more commonly with bezlotoxumab compared to placebo in clinical trials, primarily in patients with underlying congestive heart failure.[74]

Primary options

bezlotoxumab: 10 mg/kg intravenously as a single dose

subsequent recurrence

1st line – repeat course of antibiotic therapy

Back
ONGOING
|
subsequent recurrence
1st line – 

repeat course of antibiotic therapy

IDSA/SHEA recommends subsequent recurrences may be treated with the following antibiotic regimens: a standard 10- or 20-day course of fidaxomicin; a prolonged tapered and pulsed-dose regimen of oral vancomycin; or a standard 10-day course of oral vancomycin followed by rifaximin for 20 days.[2]​​​[74] The ACG recommends that oral vancomycin may be considered for subsequent recurrences.[58]

Taper and pulsed-dose regimens of vancomycin were superior to taper alone and pulsed-dose alone regimens (resolution rates of 83% versus 68% and 54%, respectively) for recurrent infection. However, evidence is limited.[98]

International guidelines may recommend different treatments and local guidance should be consulted. In the UK, the National Institute for Health and Care Excellence recommends fidaxomicin as the treatment of choice for a further episode of infection within 12 weeks of symptom resolution, or vancomycin or fidaxomicin if the further episode is more than 12 weeks after symptom resolution.[78] In Europe, the European Society of Clinical Microbiology and Infectious Diseases recommends vancomycin taper and pulse for a subsequent recurrence.[79]

While therapeutic drug monitoring is not usually recommended with the use of oral vancomycin, it may be considered on a case-by-case basis, particularly in high-risk situations where high blood levels are anticipated (e.g., renal impairment, severe disease, inflammatory bowel disease).[87]

The recommended drug regimens detailed here are based on IDSA/SHEA guidance.[2]​​​[74]

Primary options

fidaxomicin: 200 mg orally twice daily for 10 days; or 200 mg orally twice daily for 5 days, followed by 200 mg on alternate days for 20 days

Secondary options

vancomycin: tapered and pulsed regimen: 125 mg orally four times daily for 10-14 days, followed by 125 mg twice daily for 7 days, then 125 mg once daily for 7 days, then 125 mg every 2-3 days for 2-8 weeks

More

OR

vancomycin: standard regimen: 125 mg orally four times daily for 10 days

More

and

rifaximin: 400 mg orally three times daily for 20 days; start after 10-day course of vancomycin is complete

Consider – bezlotoxumab

Back
ONGOING
|
subsequent recurrence
Consider – 

bezlotoxumab

Additional treatment recommended for SOME patients in selected patient group

Bezlotoxumab, a human monoclonal antibody that binds to Clostridioides difficile toxin B, has been approved to reduce the recurrence of C difficile infection in adults who are receiving antibacterial treatment for C difficile infection and who have a high risk of recurrence. It is not indicated for the treatment of C difficile infection and is not an antibacterial drug so must be used in combination with antibiotic therapy. Bezlotoxumab should be used under specialist guidance.

IDSA/SHEA recommends using bezlotoxumab alongside standard of care antibiotics for the prevention of recurrence in patients who have had a recurrent episode within the last 6 months, particularly those who are at high risk of recurrence (e.g., age ≥65 years, immunocompromised, severe disease on presentation) and provided logistics for intravenous administration is not an issue. This recommendation is based on very low certainty evidence.[74] The ACG also recommends considering bezlotoxumab for the prevention of recurrence in patients who are at high risk of recurrence.[58]

International guidelines may recommend different treatments and local guidance should be consulted. In the UK, the National Institute for Health and Care Excellence does not recommend offering bezlotoxumab to prevent recurrent infection as it is not cost effective.[78] In Europe, the European Society of Clinical Microbiology and Infectious Diseases recommends bezlotoxumab (in addition to standard of care antibiotics) for the treatment of an initial episode in those at high risk of recurrence, as a first-line option for a first recurrence, and a second line-option for a subsequent recurrence.[79]

A single intravenous dose of bezlotoxumab (given in combination with standard antibiotic treatment) for primary or recurrent C difficile infection was associated with a 38% lower rate of recurrent infection compared with antibiotic treatment alone in 2 phase III trials. Sustained cure (no recurrent infection in 12 weeks) was achieved by 64% of patients compared with 54% of patients in the placebo group. The most common adverse effects were nausea and diarrhoea, and the drug had a similar adverse effect profile to placebo.[99] Bezlotoxumab was no better at resolving recurrent infection compared with faecal microbiota transplant.[101] Data on the use of bezlotoxumab when fidaxomicin is used as the standard of care antibiotic are limited.[74]

​In patients with a history of congestive heart failure, bezlotoxumab should be reserved for use when the benefits outweigh the risks. Heart failure was reported more commonly with bezlotoxumab compared to placebo in clinical trials, primarily in patients with underlying congestive heart failure.[74]

Primary options

bezlotoxumab: 10 mg/kg intravenously as a single dose

1st line – faecal microbiota-based therapy

Back
ONGOING
|
subsequent recurrence
1st line – 

faecal microbiota-based therapy

Faecal microbiota-based therapies include conventional faecal microbiota transplantation (FMT) and live biotherapeutic products.

US guideline recommendations on faecal microbiota-based therapies for recurrent infection vary. IDSA/SHEA recommends conventional FMT as an option in patients with at least two recurrences and where antibiotic therapy has failed.[2]​​ However, the ACG recommends considering conventional FMT as a first-line option in patients experiencing their second or further recurrence of disease to prevent further recurrences.[58] The ACG recommends that conventional FMT should be considered for recurrent infection in patients with inflammatory bowel disease.[58]​​

The American Gastroenterological Association (AGA) recommends faecal microbiota-based therapies (conventional FMT or live biotherapeutic products) for immunocompetent patients with recurrent infection after the completion of standard-of-care antibiotic therapy. The AGA recommends conventional FMT specifically for mild to moderately immunocompromised patients, and recommends against the use of all faecal microbiota-based therapies in severely immunocompromised patients. There is insufficient evidence to recommend live biotherapeutic products in immunocompromised patients.[77] Live biotherapeutic products are not included in guidelines from IDSA/SHEA or the ACG as yet as these guidelines were published before the availability of these products.​

International guidelines may recommend different treatments and local guidance should be consulted. In the UK, the National Institute for Health and Care Excellence recommends considering conventional FMT for a recurrent episode of infection in adults who have had two or more previous confirmed episodes.[102] In Europe, the European Society of Clinical Microbiology and Infectious Diseases also recommends considering conventional FMT first line for a recurrent episode in those who have had two or more previous episodes.[79]

Conventional FMT involves implanting processed stool collected from a healthy donor into the intestinal tract of infected patients to correct intestinal dysbiosis. A short induction course of oral vancomycin may be used prior to conventional FMT to reduce C difficile burden in patients who are not receiving antibiotic therapy prior to planned FMT.[2] Conventional FMT is generally well tolerated, but adverse effects may include fever, abdominal tenderness or discomfort, flatulence, nausea/vomiting, diarrhoea/constipation, and infections.[121] Conventional FMT may transmit multidrug-resistant organisms, leading to serious or life-threatening infections, particularly in patients who are immunocompromised.[128][129]​ Clinical use of FMT has the potential to transmit the SARS-CoV-2 virus and the monkeypox virus.[130][131] Faecal products may also contain food allergens. Safety concerns and the lack of large-scale availability are barriers to the widespread use of conventional FMT, and its use has decreased in recent years, partly due to the availability of approved live biotherapeutic products.

Live biotherapeutic products have become commercially available in recent years and are being used in place of conventional FMT in some centers (where they are available). These products have better standardised safety and efficacy data compared with conventional FMT, are manufactured under a standardised process, have less risk of containing known infectious pathogens, can be prescribed by any healthcare provider, and offer simpler modes of delivery.[134][135] The Food and Drug Administration (FDA) has approved two donor-derived products for the prevention of recurrence of C difficile infection in patients aged ≥18 years: faecal microbiota live (known commercially as Rebyota® in the US); faecal microbiota spores live (known commercially as Vowst® in the US). Other proprietary products may be available in other countries. Evidence is limited. The most common adverse effects were mild to moderate gastrointestinal adverse effects.​​[134][136][137]

Primary options

faecal microbiota (live) rectal: 150 mL rectally as a single dose 24-72 hours after last antibiotic dose

More

OR

faecal microbiota spores (live): 4 capsules orally once daily for 3 days starting 2-4 days after last antibiotic dose

More
back arrow

Choose a patient group to see our recommendations

Please note that formulations/routes and doses may differ between drug names and brands, drug formularies, or locations. Treatment recommendations are specific to patient groups. See disclaimer

Use of this content is subject to our disclaimer