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Microbiota Transplant Therapy for Crohn's Disease

This study is testing two forms of a new treatment for Crohn's disease (CD) called MTP-101C and MTP-101S. These treatments are capsules containing healthy donor microbiota (beneficial gut bacteria). The goal is to see if these capsules can successfully introduce healthy bacteria into the intestines of people with active Crohn's disease. Researchers will also look at how these treatments affect symptoms and changes seen during an endoscopy (a procedure to look inside the digestive tract). You may be able to join if you are between 18 and 89 years old, speak English, have a confirmed diagnosis of active Crohn's disease, and are currently on maintenance therapy for your CD. The study aims to enroll 120 participants, but the current recruitment status is unclear.

Study design
This interventional study plans to enroll 120 participants. It is testing two different forms of encapsulated microbiota transplant therapy.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, donor microbial engraftment, will be measured at 2 months after treatment.

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NCT06631586

Standardized Microbiota Transplant Therapy in Crohn's Disease

Recruiting
PHASE2Ages 18–89InterventionalBasic science
University of Minnesota
~120 participants
Updated 2026-06-22 on ClinicalTrials.gov
What's tested:MTP-101CMTP-101S

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
donor microbial engraftment
Measured over 2months

Conditions

Crohn Disease

Explore related trials

Crohn Disease

Where it's being run

2 sites across 2 states
Minnesota1
New York1

Study leadership

  • Byron Vaughn · PRINCIPAL_INVESTIGATOR · University of Minnesota

Who to contact

Byron Vaughn
[email protected]
612-624-0223
Email the study team

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Eligibility criteria

Inclusion

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).
Able to comply with study measures in the opinion of the investigator.

Exclusion

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.

What this trial measures

  • donor microbial engraftment2months

    measured in intestinal ileal biopsies