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RecruitingPhase 2

Standardized Microbiota Transplant Therapy in Crohn's Disease

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 89 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests two capsule forms of fecal microbiota transplant, MTP101C and MTP101S, in adults with active Crohn’s disease. It checks whether microbes from the capsules settle in the small and large bowel, and whether this differs by the type of Crohn’s disease. It also looks at changes in symptoms and bowel exams.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18–89 years old, speak English, and can give informed consent and follow study steps.
  • You have Crohn’s disease confirmed by symptoms and tissue tests.
  • A bowel exam with a camera shows active disease: an SES-CD score of at least 6, or at least 4 if only the last part of the small bowel is affected.
  • Your Crohn’s treatments are in the maintenance phase, meaning ongoing treatment after the starting doses.
  • Except for steroids, your Crohn’s medicine doses have been stable for 4 weeks before treatment assignment and must stay stable during the study.
  • Steroid use must be 20 mg or less by 5 days before treatment assignment. Prednisone must drop below 20 mg after 7 days.
  • Budesonide is allowed, though lowering the dose is encouraged. Your provider may allow rescue steroids up to 40 mg for 2 weeks, with a plan to lower the dose.
  • Women who have not gone through menopause or had surgery that prevents pregnancy must avoid sex or use highly effective birth control. Periodic abstinence and withdrawal do not count.

Who can't join

  • You have had most of your colon or a large amount of small bowel removed, certain stomach surgeries such as Roux-en-Y bypass, or have slow stomach emptying.
  • You have bowel narrowing that blocks the scope, needs treatment to let it pass, or causes your main symptoms; a bowel opening into a bag; or an abnormal connection between the bowel and bladder.
  • You have ulcerative colitis, suspected bowel inflammation from poor blood flow or radiation, suspected microscopic colitis, or certain growths called adenomatous polyps that have not been removed.
  • You have an active or untreated infection, used antibiotics within 14 days before treatment assignment, or expect to need antibiotics or surgery during the study.
  • You are pregnant, breastfeeding, or plan to breastfeed during the study.
  • You have had a life-threatening food allergy, have severe liver disease or liver scarring, or are expected to live 6 months or less.
  • You have fewer than 500 neutrophils per microliter of blood (a type of infection-fighting cell), an immune-system disorder called primary immunodeficiency, or cancer needing chemotherapy. Localized skin cancers other than melanoma are excepted.
  • You are receiving cell-killing cancer treatment, had an organ transplant within 6 months, or had CAR T-cell therapy or a blood-forming cell transplant within 12 months.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (3)

MN

NY

TX