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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: Recruiting Phase 2 study of Hematopoietic Stem Cell Transplantation, sponsored by University of Michigan Rogel Cancer Center.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
The incidence of grade II, III and IV GVHD (Graft Versus Host Disease) as documented on day 100 Grade II: Rash 25-50% of Body Surface Area (BSA), Bilirubin 3.1-6mg/dL, adult stool output 1000-1500mL/day or child 20-30mL/kg/day. Grade III: Rash greater than 50% BSA, bilirubin 6.1-15mg/dL, adult stool output greater than 1500mL/day or child stool output greater than 30mL/kg/day Grade IV: generalized erythroderma plus bullous formation and desquamation greater than 5% BSA, bilirubin greater than
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 |
What NCT02763033 shows while recruiting
NCT02763033 is an interventional study that assigns participants to a tested intervention. The registered 125 participants enrollment target is mid-sized for trials with a published cap, below the 9,785-participant average among 26 other Hematopoietic Stem Cell Transplantation trials with a reported enrollment target (99% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT02763033's enrollment target sits among peer trials
125 8th of 26 higher than 19 of 26 other Hematopoietic Stem Cell Transplantation trials
participants (enrollment target), bucketed by value
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