Standardized Microbiota Transplant Therapy in Crohn's Disease

NCT06631586 | Recruiting Phase 2

• 1 other identifier: GI-2024-33127
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (1)

• donor microbial engraftment

  measured in intestinal ileal biopsies

  2months

Secondary Outcomes (8)

• Changes in ileal microbial composition

  2 months

• Colonic engraftment of donor microbiota

  2 months

• Changes in colonic microbial composition

  2 months

• Engraftment

  2 months

• Microbial compositional changes

  2 months

Study Arms (2)

CD patients randomized to MTP-101C

EXPERIMENTAL

Biological: MTP-101C

CD patients randomized to MTP-101S

EXPERIMENTAL

Biological: MTP-101S

Interventions

MTP-101C BIOLOGICAL

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.

CD patients randomized to MTP-101C

MTP-101S BIOLOGICAL

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.

CD patients randomized to MTP-101S

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able and willing to provide informed consent.
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (2)

University of Minnesota

Minneapolis, Minnesota, 55414, United States

RECRUITING

NYU Langone Health

New York, New York, 10016, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Byron Vaughn

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Byron Vaughn

CONTACT

612-624-0223; bvaughn@umn.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2024
• First Posted: October 8, 2024
• Study Start: January 15, 2025
• Primary Completion (Estimated): June 15, 2029
• Study Completion (Estimated): June 15, 2029
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

US (2)