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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03621657
The ClinicalTrials.gov registry entry for NCT03621657 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 12,066-participant average among 13 other Clostridium Difficile Infection trials with a reported enrollment target (100% lower). The listed sponsor is University of Wisconsin, Madison, which has 1,039 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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