Stool transplant plus antibody drug shows promise against recurrent c. diff in IBD patients
NCT ID NCT03829475
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether combining a fecal microbiota transplant (FMT) with the drug bezlotoxumab could prevent repeat Clostridium difficile infections in people with inflammatory bowel disease (IBD). Sixty-one adults with at least two prior C. diff infections were randomly assigned to receive FMT plus bezlotoxumab or FMT plus a placebo. Participants were followed for three months to see if the infection came back.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- fecal microbiota transplantation (FMT) plus bezlotoxumab (Zinplava)
- What this could lead to
- If it works, this combination could offer a more effective way to prevent repeat C. diff infections in people with inflammatory bowel disease.
- What could go wrong
- This is a small, early-phase study (61 participants) and results may not apply to everyone. The treatment involves infusing donor stool, which carries unknown infection risks.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
61 people
The number who actually took part.
- Started
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Jan 2020
- Finished
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Jun 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Adults age 18 or greater * History of ≥ 2 episodes of recurrent CDI. CDI is defined as the presence of diarrhea ( Bristol 6 or 7 for 48 hours and a confirmatory test for CDI). Preferred testing will be a two-step method using GDH/EIA toxin, though PCR will be accepted based on hospital availability with confirmation of the most recent episode occurring within the prior 3 months * Confirmed diagnosis of IBD (ulcerative colitis, Crohn's disease or indeterminate colitis) * Undergoing FMT via colonoscopy for CDI as part of standard medical care Exclusion Criteria: * Unable or unwilling to undergo a colonoscopy * Inpatient status, though patients can be screened while inpatients, the must be outpatient for the planned colonoscopy. * Anticipated immediate or upcoming surgery within 30 days * Need for continued non-anti-CDI antibiotic therapy * History of total proctocolectomy * Female patients who are pregnant or breastfeeding or plan to become pregnant in the next 6 months. * Patients who are unable to give informed consent * Participation in a clinical trial in the preceding 30 days or simultaneously during this trial * Severe food allergy (anaphylaxis or anaphylactoid-like reaction) * Life expectancy \< 6 months * Unable to adhere to protocol requirements * Patient who have received an FMT in the past year * Any condition that the physician investigators deems unsafe, including other conditions or medications that the investigator determines that it will put the subject at greater risk from FMT * Patient who is diagnosed with NYHA class 3 or 4 Heart Failure * Lab value of WBC \<3.0 x 103/mm3 , Platelets \<100 x 103/mm3 , ALT or AST \> 1.5 x institutional ULN * EBV or CMV negative if a patient is severely immunosuppressed ( defined as 3 or more immunosuppressing agents)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
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Other studies related to the condition(s) this trial covers.
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