Actively Recruiting

Phase 2
Age: 18Years - 89Years
All Genders
NCT06631586

Standardized Microbiota Transplant Therapy in Crohn's Disease

Led by University of Minnesota · Updated on 2026-04-29

120

Participants Needed

2

Research Sites

230 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Standardized Microbiota Transplant Therapy in Crohn's Disease

Who Can Participate

Age: 18Years - 89Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Able and willing to provide informed consent.
  • 18-89 years of age.
  • English speaking.
  • Diagnosis of Crohn's disease based on typical clinical and histologic features.
  • Active disease on endoscopy with SES-CD score 6 or 4 for isolated ileal disease.
  • Current Crohn's disease therapies are in maintenance dosing phase at randomization.
  • Ongoing Crohn's disease therapy (except steroids) must be stable for 4 weeks prior and during the study.
  • Steroid use at 20mg or less by 5 days before randomization.
  • Prednisone must be tapered below 20mg after 7 days.
  • Budesonide use allowed during study, tapering encouraged.
  • Rescue steroid courses (up to 40mg for two weeks with planned taper) allowed as per provider discretion.
  • Women not post-menopausal or surgically sterile must use effective birth control or remain abstinent; periodic abstinence or early withdrawal not acceptable.
  • Able to comply with study procedures as judged by investigator.
Not Eligible

You will not qualify if you...

  • Extensive bowel resection causing short bowel syndrome risk.
  • Documented gastroparesis.
  • History of pylorus non-preserving gastric surgery such as Roux-en-Y gastric bypass.
  • Symptomatic strictures preventing or requiring intervention for colonoscope passage or causing predominant symptoms.
  • Presence of ileostomy or colostomy.
  • Entero-vesicular fistula (bowel to bladder).
  • Suspicion of ischemic colitis, radiation colitis, or microscopic colitis.
  • Diagnosis of ulcerative colitis.
  • Active or untreated infection.
  • Adenomatous polyps not removed.
  • Antibiotic use within 14 days before randomization.
  • Current pregnancy.
  • Currently breastfeeding or planning to breastfeed.
  • History of anaphylactic food allergies.
  • End stage liver disease or cirrhosis.
  • Anticipated need for antibiotics during study.
  • Anticipated surgical procedure during study.
  • Absolute neutrophil count below 500 cells/bcL.
  • Diagnosis of primary immunodeficiency.
  • Active malignancy needing chemotherapy (except localized non-melanomatous skin cancers).
  • Receiving active cytotoxic therapy for solid tumors or blood cancers.
  • Solid organ transplant within 6 months before randomization.
  • Chimeric antigen receptor T-cell therapy or hematopoietic cell transplant within past 12 months.
  • Life expectancy less than 6 months.

AI-Screening

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Trial Site Locations

Total: 2 locations

1

University of Minnesota

Minneapolis, Minnesota, United States, 55414

Actively Recruiting

2

NYU Langone Health

New York, New York, United States, 10016

Not Yet Recruiting

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Research Team

B

Byron Vaughn

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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