Gut bacteria transplant could tame Crohn's inflammation
NCT ID NCT06631586
First seen Jun 27, 2026 · Last updated Sep 09, 2026 · Updated 2 times
Summary
This study tests whether capsules containing freeze-dried healthy donor gut bacteria can take root in the intestines of people with Crohn's disease. Researchers will check if the bacteria engraft in the ileum and colon, and explore changes in symptoms and inflammation. The trial involves 120 adults with active Crohn's disease who are already on stable treatment.
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 transplant (FMT) capsules
- What this could lead to
- If successful, this could point toward a new way to treat Crohn's disease by restoring healthy gut bacteria, potentially reducing inflammation and symptoms.
- What could go wrong
- This is an early phase 2 trial with only 120 participants, so results may not apply to everyone. The treatment may not engraft effectively or improve symptoms, and side effects like bloating or infection are possible.
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
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2025
- Expected to finish
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Jun 2029
An estimate. End dates often move.
- 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 to 89 years
- 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: * Able and willing to provide informed consent. * 18-89 years of age. * English speaking. * Diagnosis of CD based on typical clinical and histologic features. * Active disease on endoscopy: * SES-CD \>= 6 * SES-CD \>= 4 for isolated ileal disease * Current CD therapies are in the maintenance phase of dosing at the time of randomization. * Any ongoing CD therapy (apart from steroid use) must be at stable doses for 4 weeks prior to randomization and remain stable over study course. * Steroid use 20mg or less by 5 days prior to randomization. * Steroid use stipulations: * Prednisone must be tapered below 20mg after 7 days. * Any use of budesonide over the study period is allowed although tapering is encouraged. * Rescue medications: Steroid courses (up to 40mg for two weeks with a planned taper) are allowed at the discretion of the treating provider. Study drug therapy will be stopped on a case-by-case basis on discussion with the participant and treating provider. * Women who are not post-menopausal (at least 12 months of non-therapy induced amenorrhea) or surgically sterile (e.g., absence of ovaries and/or uterus) must remain abstinent or use a highly effective form of birth control (e.g., oral contraception, transdermal patch, barrier, intrauterine device). o Periodic abstinence and early withdraw are not acceptable methods. * Able to comply with study measures in the opinion of the investigator. Exclusion Criteria: * Extensive bowel resection: i.e., subtotal colectomy or substantial removal of small bowel where short bowel syndrome could be a concern. * Documented gastroparesis * History of pylorus non-preserving gastric surgery, e.g., Roux-en-Y gastric bypass. * Symptomatic stricture defined as a stricture that: * Cannot be traversed by the colonoscope, * Requires intervention to be traversed, * Is otherwise responsible for the predominant clinical picture, in the opinion of the investigator. * Presence of ileostomy or colostomy. * Entero-vesicular fistula (i.e., fistula from bowel to bladder). * Suspicion of ischemic colitis, radiation colitis or microscopic colitis. * Diagnosis of ulcerative colitis. * Active or untreated infection. * Adenomatous polyps that have not been removed. * Use of antibiotics within 14-days of randomization. * Current pregnancy. * Current breastfeeding or planning to breastfeed over the study period. * History of anaphylactic food allergies. * End stage liver disease or cirrhosis. * Anticipated need for antibiotics over the study period. * Anticipated surgical procedure over the study period. * An absolute neutrophil count \<500 cell/µL. * Diagnosis of a primary immunodeficiency. * Active malignancy requiring the use of chemotherapeutic agent (except for localized non-melanomatous skin cancers). * Patients receiving active cytotoxic therapy for solid tumors and hematologic malignancies. * Any solid organ transplant within 6 months of randomization. * Use of chimeric antigen receptor T-cell therapy or hematopoietic cell transplant within the past 12 months * Life expectancy \<=6 months.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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NYU Langone Health
NOT_YET_RECRUITINGNew York, New York, 10016, United States
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UT Southwestern
RECRUITINGDallas, Texas, 75390-9151, United States
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University of Minnesota
RECRUITINGMinneapolis, Minnesota, 55414, United States
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Other studies related to the condition(s) this trial covers.
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- Can a liquid diet calm Crohn's in kids?
- Which IBD therapy works best for kids? researchers compare two approaches
- Can trained peer mentors ease the mental toll of IBD?
- Can a new pill tame inflammatory bowel disease?