New bacteria slurry takes on poop transplants for stubborn gut infection
NCT ID NCT05911997
First seen Jun 24, 2026 · Last updated Sep 04, 2026 · Updated 3 times
Summary
This study tests two treatments for people with repeat C. diff infections: a lab-made bacteria mix called MTC01 and a fecal transplant (FMT) from a healthy donor. Both are given during a colonoscopy. The goal is to see which is safer and better at stopping the infection from coming back. About 60 adults with at least two recent C. diff episodes will take part.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- MTC01 (a slurry of bacteria) and fecal microbiota transplantation (FMT) from a healthy donor
- What this could lead to
- If successful, this could point toward a safer, more effective treatment for recurrent C. difficile infections, reducing the need for repeated antibiotics.
- What could go wrong
- This is an early Phase 1 trial with only 60 participants, so results may not apply broadly. There are risks of serious side effects, including infection or allergic reactions.
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 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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38 people
The number who actually took part.
- Started
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Jan 2024
- Finished
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Dec 2025
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Ages eligible for study: 18 years and older * Able and willing to provide written informed consent * History of recurrent CDI defined as 2 episodes of CDI occurring within the previous 6 months (inclusive of the current episode) * Subjects with a qualifying recurrent CDI episode, defined as: * History of diarrhea (\>=3 unformed stools per day for 2 or more consecutive days that is clinically consistent with CDI * Documented positive stool test by local laboratory for toxigenic C. difficile (toxin EIA or PCR-based testing) for the current CDI episode within 60 days prior to randomization. * Received a course of standard-of-care (SOC) CDI antibiotics for the most recent CDI episode (for 10 to 42 days, with exact duration, antibiotic type and dose at the discretion of the Investigator) * Demonstrated adequate clinical response, defined as \<= 3 unformed stools per day for 2 or more consecutive days during SOC CDI antibiotics prior to randomization. * CDI symptoms started within 60 days prior to randomization. Exclusion Criteria: * Female subjects who are pregnant or breastfeeding or are planning to become pregnant during the study. * Women with reproductive potential should use a reliable method of birth control: * Consistent use of an approved hormonal contraception (birth control pill/patches, rings); An intrauterine device (IUD); Contraceptive injection (Depo-Provera); Double barrier methods (Diaphragm with spermicidal gel or condoms with contraceptive foam); Sexual abstinence (no sexual intercourse) or Sterilization * Known or suspected toxic megacolon, ileus or bowel obstruction at the time of enrollment. * Subjects with active gastroenteritis due to infectious causes other than CDI * Subjects with allergies to ingredients present in the investigational product * Prior participation in studies of investigational live biotherapeutic products or FMT within the last 6 months. * Major gastrointestinal surgery within the last 3 months before enrollment. * Use of drugs that alter gut motility. * History of acute leukemia or hematopoietic stem cell transplantation or myelosuppressive chemotherapy within 2 months prior to enrollment. * 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 * 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 * Clinically significant abnormal lab values including but not limited to WBC \>15 x 103/mm3, ANC \<0.5 x 103/mm3, or laboratory evidence of acute kidney injury at Investigator's discretion, at screening * If a patient is heavily immunosuppressed and is negative for CMV or EBV
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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
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Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States