RECRUITING

Standardized Microbiota Transplant Therapy in Crohn's Disease

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Conditions

Crohn Disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Standardized Microbiota Transplant Therapy in Crohn's Disease

Quick Facts

Study Start:2025-01-15
Study Completion:2029-06-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06631586

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 89 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Able and willing to provide informed consent.
  2. * 18-89 years of age.
  3. * English speaking.
  4. * Diagnosis of CD based on typical clinical and histologic features.
  5. * Active disease on endoscopy:
  6. * SES-CD \>= 6
  7. * SES-CD \>= 4 for isolated ileal disease
  8. * Current CD therapies are in the maintenance phase of dosing at the time of randomization.
  9. * 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.
  10. * Steroid use 20mg or less by 5 days prior to randomization.
  11. * Steroid use stipulations:
  12. * Prednisone must be tapered below 20mg after 7 days.
  13. * Any use of budesonide over the study period is allowed although tapering is encouraged.
  14. * 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.
  15. * 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).
  16. * Able to comply with study measures in the opinion of the investigator.
  1. * Extensive bowel resection: i.e., subtotal colectomy or substantial removal of small bowel where short bowel syndrome could be a concern.
  2. * Documented gastroparesis
  3. * History of pylorus non-preserving gastric surgery, e.g., Roux-en-Y gastric bypass.
  4. * Symptomatic stricture defined as a stricture that:
  5. * Cannot be traversed by the colonoscope,
  6. * Requires intervention to be traversed,
  7. * Is otherwise responsible for the predominant clinical picture, in the opinion of the investigator.
  8. * Presence of ileostomy or colostomy.
  9. * Entero-vesicular fistula (i.e., fistula from bowel to bladder).
  10. * Suspicion of ischemic colitis, radiation colitis or microscopic colitis.
  11. * Diagnosis of ulcerative colitis.
  12. * Active or untreated infection.
  13. * Adenomatous polyps that have not been removed.
  14. * Use of antibiotics within 14-days of randomization.
  15. * Current pregnancy.
  16. * Current breastfeeding or planning to breastfeed over the study period.
  17. * History of anaphylactic food allergies.
  18. * End stage liver disease or cirrhosis.
  19. * Anticipated need for antibiotics over the study period.
  20. * Anticipated surgical procedure over the study period.
  21. * An absolute neutrophil count \<500 cell/µL.
  22. * Diagnosis of a primary immunodeficiency.
  23. * Active malignancy requiring the use of chemotherapeutic agent (except for localized non-melanomatous skin cancers).
  24. * Patients receiving active cytotoxic therapy for solid tumors and hematologic malignancies.
  25. * Any solid organ transplant within 6 months of randomization.
  26. * Use of chimeric antigen receptor T-cell therapy or hematopoietic cell transplant within the past 12 months
  27. * Life expectancy \>=6 months.

Contacts and Locations

Study Contact

Byron Vaughn
CONTACT
612-624-0223
bvaughn@umn.edu

Principal Investigator

Byron Vaughn
PRINCIPAL_INVESTIGATOR
University of Minnesota

Study Locations (Sites)

University of Minnesota
Minneapolis, Minnesota, 55414
United States

Collaborators and Investigators

Sponsor: University of Minnesota

  • Byron Vaughn, PRINCIPAL_INVESTIGATOR, University of Minnesota

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-15
Study Completion Date2029-06-15

Study Record Updates

Study Start Date2025-01-15
Study Completion Date2029-06-15

Terms related to this study

Additional Relevant MeSH Terms

  • Crohn Disease