RecruitingPhase 2NCT06631586

Standardized Microbiota Transplant Therapy in Crohn's Disease


Sponsor

University of Minnesota

Enrollment

120 participants

Start Date

Jan 15, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Crohn's disease (CD) develops because of a disruption of homeostasis between the gut microbiota and the host immune system resulting in excessive inflammation in the intestinal tract. Current drug therapies for CD are directed at the immune system. The emergence of fecal microbiota transplantation (FMT) for the treatment of recurrent C. difficile infections (rCDI) has opened a frontier of restorative therapies targeting the gut microbiome. This study aims to assess if two forms of encapsulated FMT material (MTP101C and MTP101S) can effectively engraft in the ileum and colon of individuals with CD. This study will also assess how the impact of CD phenotype impacts engraftment. Finally this study will explore symptom and endoscopic changes before and after these two therapies.


Eligibility

Min Age: 18 YearsMax Age: 89 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a standardized gut microbiome transplant (also called fecal microbiota transplant, or FMT) can help people with active Crohn's disease who are not responding adequately to their current medications. **You may be eligible if...** - You are between 18 and 89 years old - You speak English - You have a confirmed Crohn's disease diagnosis with active inflammation visible on colonoscopy - Your current medications are at a stable dose **You may NOT be eligible if...** - You have had significant bowel surgery (such as removal of most of your colon or small bowel) - You have gastroparesis or a history of gastric bypass surgery - You have a symptomatic intestinal narrowing (stricture) or a bowel-to-bladder fistula - You have a colostomy or ileostomy - You are pregnant or breastfeeding - You have an active or untreated infection - You have a primary immune deficiency or are receiving active cancer chemotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALMTP-101C

MTP-101C composed of double-encapsulated freeze-dried healthy donor microbiota. The fecal microbiota is frozen in the presence of a lyoprotectant (trehalose), freeze-dried, and double encapsulated into hypromellose capsules (Lonza, Morristown, NJ). Each capsule contains ≥ 1 x 10 11 and ≤ 2.0 x 10 11 bacterial cells.

BIOLOGICALMTP-101S

MTP-101S contains identical healthy donor microbiota double encapsulated in VCaps Plus (Lonza). These capsules are also composed of hypromellose but disintegrate in the proximal small bowel. Each capsule contains ≥ 1 x 10 11 and ≤ 2.0 x 10 11 bacterial cells.


Locations(2)

University of Minnesota

Minneapolis, Minnesota, United States

NYU Langone Health

New York, New York, United States

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NCT06631586


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