Standardized Microbiota Transplant Therapy in Crohn's Disease
ConditionCrohn Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-89
SponsorUniversity of Minnesota
About this trial
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.
Eligibility criteria
Qualifiers
Able and willing to provide informed consent.
18-89 years of age.
English speaking.
Diagnosis of CD based on typical clinical and histologic features.
Disqualifiers
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.
Cannot be traversed by the colonoscope,
Trial design
Treatments tested in this trial
- MTP-101C
- MTP-101S
Treatment groups
120 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov