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Recruiting Phase 2 Interventional

Standardized Microbiota Transplant Therapy in Crohn's Disease

ClinicalTrials.gov ID: NCT06631586

Public ClinicalTrials.gov record NCT06631586. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 9, 2026, 3:53 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT06631586
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 2
Lead sponsor
University of Minnesota
Other
Enrollment
120 participants

Conditions and interventions

Conditions

Interventions

Biological

Eligibility (public fields only)

Age range
18 Years to 89 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 14, 2025
Primary completion
Jun 14, 2029
Completion
Jun 14, 2029
Last update posted
Sep 7, 2026

2025 – 2029

United States locations

U.S. sites
3
U.S. states
3
U.S. cities
3
Facility City State ZIP Site status
University of Minnesota Minneapolis Minnesota 55414 Recruiting
NYU Langone Health New York New York 10016 Not yet recruiting
UT Southwestern Dallas Texas 75390-9151 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06631586, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 7, 2026 · Synced Sep 9, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06631586 live on ClinicalTrials.gov.

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