Standardized Microbiota Transplant Therapy in Crohn's Disease
Phase 2 · Testing MTP-101C and MTP-101S · 3 sites · University of Minnesota
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing MTP-101C (a biologic) and MTP-101S (a biologic) to better understand how the disease works. Condition(s) listed: Crohn Disease.
Participants are assigned to groups by chance (randomized).
It is blinded: participants and the study team do not know who receives what.
Phase 2 studies test whether a treatment shows signs of working, and keep checking safety, in a larger group of people with the condition.
Who can join
- Ages 18 to 89
- Any sex
Some of the main requirements, copied from the record:
- Able and willing to provide informed consent.
- 18-89 years of age.
- English speaking.
Plus 14 more requirement(s). There are also 27 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 120 participants are expected to take part.
- Start date: 2025-01-15.
- Main results expected around 2029-06-15 (estimate from the record).
- 3 study sites listed (2 marked recruiting) in United States.
Main thing being measured
- donor microbial engraftment (2months)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Phase 2 |
| Study type | Interventional |
| Conditions | Crohn Disease |
| Lead sponsor | University of Minnesota |
| Enrollment | 120 (estimated) |
| Start date | 2025-01-15 |
| Primary completion (est.) | 2029-06-15 |
| First posted | 2024-10-08 |
| Last updated | 2026-09-08 |
| Official title | Standardized Microbiota Transplant Therapy in Crohn's Disease |
| ClinicalTrials.gov ID | NCT06631586 |
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. - 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.
Full eligibility criteria (from the record)
Inclusion Criteria: * 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). o Periodic abstinence and early withdraw are not acceptable methods. * Able to comply with study measures in the opinion of the investigator. Exclusion Criteria: * 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.
Locations (3)
| Site | City | Country | Site status |
|---|---|---|---|
| University of Minnesota | Minneapolis, Minnesota | United States | Recruiting |
| NYU Langone Health | New York, New York | United States | Not yet recruiting |
| UT Southwestern | Dallas, Texas | United States | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.