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NCT03476317 · ClinicalTrials.gov registry record · Phase 2
Pilot Study of Fundamental Modification of the Gut Microbiota in the Treatment of Refractory Crohn's Disease
A Phase 2 study, sponsored by Children's Hospital of Philadelphia.
- Completed
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
NCT03476317 is a Phase 2 study that has completed, run by Children's Hospital of Philadelphia. The registered enrollment target is 10 participants.
The verdict
NCT03476317, a Phase 2 study, has completed, sponsored by Children's Hospital of Philadelphia.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the effect of a novel gut microbiota-targeted therapeutic regimen (bowel lavage and antibiotics with or without an antifungal) in the management of active Crohn's Disease (CD) or indeterminate colitis (IBDU) that is refractory to conventional, immunosuppressive therapy. In addition, the study will determine the effect of PEG lavage alone on fecal calprotectin and gut microbiota in patients who are undergoing a PEG lavage for clinical care.
Interventions
- DRUG Vancomycin
- DRUG Fluconazole
- DRUG Ciprofloxacin
- DRUG Polyethylene Glycol 3350
- DRUG Neomycin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2018-07-12 |
| Est. Completion | 2020-12-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03476317
The ClinicalTrials.gov registry entry for NCT03476317 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Hospital of Philadelphia, which has 431 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Vancomycin is the first listed.
NCT03476317 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03476317 about?
NCT03476317 is a clinical study titled "Pilot Study of Fundamental Modification of the Gut Microbiota in the Treatment of Refractory Crohn's Disease". The purpose of this study is to determine the effect of a novel gut microbiota-targeted therapeutic regimen (bowel lavage and antibiotics with or without an antifungal) in the management of active Crohn's Disease (CD) or indeterminate colitis (IBDU) that is refractory to conventional, immunosuppress...
What is the current status of trial NCT03476317?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2018-07-12. Estimated completion is 2020-12-31.
What interventions are being tested in trial NCT03476317?
The interventions under investigation include: Vancomycin (DRUG), Fluconazole (DRUG), Ciprofloxacin (DRUG), Polyethylene Glycol 3350 (DRUG), Neomycin (DRUG).
Who is sponsoring clinical trial NCT03476317?
This trial is sponsored by Children's Hospital of Philadelphia, which has 431 total clinical trials registered on ClinicalTrials.gov.
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