Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 2 study, sponsored by Children's Hospital of Philadelphia.
NCT03476317 is a Phase 2 study that has completed, run by Children's Hospital of Philadelphia. The registered enrollment target is 10 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Change in fecal calprotectin between stool samples collected at baseline and day 12 after procedure in Group 2 participants.
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 |
What the finished NCT03476317 record still lists
NCT03476317 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 5 interventions - of which Vancomycin is the first listed.
NCT03476317 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03476317's enrollment target sits among peer trials
10 1968th of 2000 higher than 12 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00623389 · 10 participants · NA
Evaluation of an Advanced Lower Extremity Neuroprostheses
- NCT01241864 · 10 participants · Phase 2
Islet Transplantation in Type 1 Diabetic Kidney Allograft
- NCT01293214 · 10 participants · NA
Vascularized Composite Allotransplantation for Multiple Extremity Amputations
- NCT01474148 · 10 participants · NA
A Neuroprosthesis for Seated Posture and Balance
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI