Ignite Creation Date:
2025-12-25 @ 2:52 AM
Ignite Modification Date:
2026-03-04 @ 7:50 PM
Study NCT ID:
NCT02763033
Status:
RECRUITING
Last Update Posted:
2025-11-28
First Post:
2016-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dietary Manipulation of the Microbiome-metabolomic Axis for Mitigating GVHD in Allo HCT Patients
Sponsor:
University of Michigan Rogel Cancer Center
Organization:
Study Overview
Official Title:
Dietary Manipulation of the Microbiome-metabolomic Axis for Mitigating GVHD in Allo HCT Patients
Status:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| HUM00112318 | OTHER | The University of Michigan | View | |
| P01HL149633 | NIH | None | https://reporter.nih.gov/quic… | View |