Microbiota transplant therapy for Crohn's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of two forms of encapsulated fecal microbiota transplantation (MTP101C and MTP101S) in patients with Crohn's disease. It aims to determine how well these therapies can engraft in the ileum and colon, and how the phenotype of Crohn's disease affects this engraftment. Additionally, the study will assess changes in symptoms and endoscopic findings before and after treatment. Participants will be monitored for their response to these therapies over the course of the study.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Minnesota
  Minneapolis, Minnesota, United States Recruiting
• UT Southwestern
  Dallas, Texas, United States Recruiting
• NYU Langone Health
  New York, New York, United States Not yet recruiting

Study contacts

• Principal investigator: Byron Vaughn — University of Minnesota
• Study coordinator: Byron Vaughn
• Email: bvaughn@umn.edu
• Phone: 612-624-0223

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.