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NCT05067595 · ClinicalTrials.gov registry record · Phase 1
Fecal Microbiota Transplant and Dietary Fiber Supplementation for the Treatment of Gut Graft Versus Host Disease
A Phase 1 study of Intestinal Graft Versus Host Disease, sponsored by Fred Hutchinson Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 72
- Enrollment target
- 1
- Study location
NCT05067595: Recruiting Phase 1 study of Intestinal Graft Versus Host Disease, sponsored by Fred Hutchinson Cancer Center.
NCT05067595 is a Phase 1 study of Intestinal Graft Versus Host Disease that is actively recruiting participants, run by Fred Hutchinson Cancer Center. The registered enrollment target is 72 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05067595, a Phase 1 study of Intestinal Graft Versus Host Disease, is actively recruiting participants, sponsored by Fred Hutchinson Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 72 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial studies how well fecal microbiota transplant and dietary fiber supplementation work in treating patients with gut graft versus host disease. Fecal microbiota transplant entails inoculating donor stool into a recipient's gastrointestinal tract. Changing the gut microbiome by fecal microbiota transplant and fiber supplementation may help treat gut graft versus host disease.
Primary Outcome
Analyses will consist of summary statistics of the bacterial diversity in the microbiome (e.g., the alpha diversity, the abundance of bacterial species associated with protection from graft versus host disease \[GvHD\]).
Conditions Studied
Interventions
- PROCEDURE Colonoscopy
- OTHER Survey Administration
- BIOLOGICAL Fecal Microbiota Transplantation
- DIETARY_SUPPLEMENT Nutritional Supplementation
Study Locations (1)
Washington
- Fred Hutch/University of Washington Cancer Consortium - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2025-01-24 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 1 |
What NCT05067595 shows while recruiting
NCT05067595 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% higher).
The record links to 1 condition, with Intestinal Graft Versus Host Disease appearing as the primary indexed condition, and to 4 interventions - of which Colonoscopy is the first listed.
NCT05067595 reports a single indexed study location in Washington.
Frequently Asked Questions
What is clinical trial NCT05067595 about?
NCT05067595 is a clinical study titled "Fecal Microbiota Transplant and Dietary Fiber Supplementation for the Treatment of Gut Graft Versus Host Disease". This phase I trial studies how well fecal microbiota transplant and dietary fiber supplementation work in treating patients with gut graft versus host disease. Fecal microbiota transplant entails inoculating donor stool into a recipient's gastrointestinal tract. Changing the gut microbiome by fecal ...
What is the current status of trial NCT05067595?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 72 participants. The study started on 2025-01-24. Estimated completion is 2027-12-31.
What conditions does trial NCT05067595 study?
This clinical trial studies the following conditions: Intestinal Graft Versus Host Disease.
What interventions are being tested in trial NCT05067595?
The interventions under investigation include: Colonoscopy (PROCEDURE), Survey Administration (OTHER), Fecal Microbiota Transplantation (BIOLOGICAL), Nutritional Supplementation (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT05067595?
This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05067595 being conducted?
This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05067595's enrollment target sits among peer trials
72 736th of 2000 higher than 1,254 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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
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