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NCT02763033 · ClinicalTrials.gov registry record · Phase 2
Dietary Manipulation of the Microbiome-metabolomic Axis for Mitigating GVHD in Allo HCT Patients
A Phase 2 study of Hematopoietic Stem Cell Transplantation, sponsored by University of Michigan Rogel Cancer Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 125
- Enrollment target
- 1
- Study location
NCT02763033 is a Phase 2 study of Hematopoietic Stem Cell Transplantation that is actively recruiting participants, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 125 participants, below the 9,785-participant average among 26 other Hematopoietic Stem Cell Transplantation trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02763033, a Phase 2 study of Hematopoietic Stem Cell Transplantation, is actively recruiting participants, sponsored by University of Michigan Rogel Cancer Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 125 participants
- Enrollment target
- 1
- Study location
Study Summary
Investigators are evaluating the feasibility, safety and early efficacy of administering a commercially available dietary supplement containing potato-based resistant starch to subjects undergoing allogeneic SCT (stem cell transplant). The intervention will begin immediately prior to the conditioning phase and continue through day 100. Investigators hypothesize that short term administration of a resistant starch is capable of increasing levels of butyrate within the intestine that will reduce rates of acute GVHD (Graft-Versus-Host Disease).
Conditions Studied
Interventions
- DRUG Bob's Red Mill®
- OTHER Starch Placebo
Study Locations (1)
Michigan
- University of Michigan Cancer Center - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 125 participants |
| Start Date | 2017-04-26 |
| Est. Completion | 2026-04 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02763033
The ClinicalTrials.gov registry entry for NCT02763033 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 125 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 9,785-participant average among 26 other Hematopoietic Stem Cell Transplantation trials with a reported enrollment target (99% lower). The listed sponsor is University of Michigan Rogel Cancer Center, which has 292 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Hematopoietic Stem Cell Transplantation appearing as the primary indexed condition, and to 2 interventions - of which Bob's Red Mill® is the first listed.
NCT02763033 reports 1 study location spanning 1 distinct geographic area - top geographies include Michigan.
Frequently Asked Questions
What is clinical trial NCT02763033 about?
NCT02763033 is a clinical study titled "Dietary Manipulation of the Microbiome-metabolomic Axis for Mitigating GVHD in Allo HCT Patients". Investigators are evaluating the feasibility, safety and early efficacy of administering a commercially available dietary supplement containing potato-based resistant starch to subjects undergoing allogeneic SCT (stem cell transplant). The intervention will begin immediately prior to the conditionin...
What is the current status of trial NCT02763033?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 125 participants. The study started on 2017-04-26. Estimated completion is 2026-04.
What conditions does trial NCT02763033 study?
This clinical trial studies the following conditions: Hematopoietic Stem Cell Transplantation.
What interventions are being tested in trial NCT02763033?
The interventions under investigation include: Bob's Red Mill® (DRUG), Starch Placebo (OTHER).
Who is sponsoring clinical trial NCT02763033?
This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02763033 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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