Standardized Microbiota Transplant Therapy in Crohn's Disease
Recruiting
Phase 2
Interventional Study
Crohn Disease
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 89
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Basic Science
- Participants needed
- 120 (estimated)
- Sponsor
- University of Minnesota · Other
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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 restorat…
Trial Locations
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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 …
Contacts