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NCT03621657 · ClinicalTrials.gov registry record · Phase 2
The GRAFT Study: Gut RecolonizAtion by Fecal Transplantation
A Phase 2 study of Clostridium Difficile Infection and CDI, sponsored by University of Wisconsin, Madison.
- Completed
- Registry status
- Phase 2
- Development phase
- 1
- Enrollment target
- 1
- Study location
NCT03621657: Completed Phase 2 study of Clostridium Difficile Infection and CDI, sponsored by University of Wisconsin, Madison.
NCT03621657 is a Phase 2 study of Clostridium Difficile Infection and CDI that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 1 participants, below the 12,066-participant average among 13 other Clostridium Difficile Infection trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03621657, a Phase 2 study of Clostridium Difficile Infection and CDI, has completed, sponsored by University of Wisconsin, Madison.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 1 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary objective of this study is to compare the gut microbiota and clinical outcomes of oral FMT during antibiotic treatment, immediately following antibiotic treatment, and placebo. The second objective is to assess the safety and feasibility of daily oral Fecal Microbiome Transplant (FMT) as a treatment option.
Primary Outcome
Assess microbial composition of stool using 16s targeted sequencing and shotgun metagenomics
Conditions Studied
Interventions
- DRUG Placebo oral capsule
- DRUG Low Dose FMT Capsule DE
- DRUG Single Dose FMT Capsule DE
Study Locations (1)
Wisconsin
- University of Wisconsin Hospital & Clinics - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2019-03-21 |
| Est. Completion | 2020-02-27 |
| Phase | Phase 2 |
What the finished NCT03621657 record still lists
NCT03621657 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 12,066-participant average among 13 other Clostridium Difficile Infection trials with a reported enrollment target (100% lower).
The record links to 3 conditions, with Clostridium Difficile Infection appearing as the primary indexed condition, and to 3 interventions - of which Placebo oral capsule is the first listed.
NCT03621657 reports a single indexed study location in Wisconsin.
Frequently Asked Questions
What is clinical trial NCT03621657 about?
NCT03621657 is a clinical study titled "The GRAFT Study: Gut RecolonizAtion by Fecal Transplantation". The primary objective of this study is to compare the gut microbiota and clinical outcomes of oral FMT during antibiotic treatment, immediately following antibiotic treatment, and placebo. The second objective is to assess the safety and feasibility of daily oral Fecal Microbiome Transplant (FMT) as...
What is the current status of trial NCT03621657?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 1 participants. The study started on 2019-03-21. Estimated completion is 2020-02-27.
What conditions does trial NCT03621657 study?
This clinical trial studies the following conditions: Clostridium Difficile Infection, CDI, C.Difficile Diarrhea.
What interventions are being tested in trial NCT03621657?
The interventions under investigation include: Placebo oral capsule (DRUG), Low Dose FMT Capsule DE (DRUG), Single Dose FMT Capsule DE (DRUG).
Who is sponsoring clinical trial NCT03621657?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03621657 being conducted?
This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03621657's enrollment target sits among peer trials
1 14th of 13 the lowest of 13 other Clostridium Difficile Infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Clostridium Difficile Infection 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.
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