Modification of the Intestinal Microbiome by Diet Intervention to Mitigate Acute Graft-Versus-Host Disease
| Status: | Recruiting |
|---|---|
| Conditions: | Blood Cancer, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | 10 - Any |
| Updated: | 8/4/2018 |
| Start Date: | January 13, 2017 |
| End Date: | December 2020 |
| Contact: | Pavan Reddy, M.D. |
| Email: | reddypr@umich.edu |
| Phone: | 734-936-8785 |
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).
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).
Inclusion Criteria:
- Subjects undergoing matched related full intensity allogeneic HSCT (hematopoietic stem
cell transplantation)
- Age ≥ 18 years for the feasibility phase. Age ≥10 years old AND ≥50 kg for the phase
II portion.
- Karnofsky >70%, (Karnofsky Performance Status: an attempt to quantify cancer patients'
general well-being and activities of daily life. The score ranges from 0 to 100 where
100 is "perfect" health and 0 is death.)
- Subjects must be able to swallow capsules/tablets
- Ability to understand and the willingness to sign a written informed consent
- Willingness to consent / co-enroll on BMT long term follow up study or HUM00043287
(UMCC2001-0234)
- Availability of an HLA (human leukocyte antigen) matched related donor.
Exclusion Criteria:
- Patients with inflammatory bowel disease.
- Patients with a history of gastric bypass surgery.
- Patients with active Clostridium difficile infection at the time of study enrollment.
Active infection is defined as a stool sample positive for Clostridium difficile toxin
via EIA (enzyme immunoassay) and either symptoms (frequent loose stools) OR imaging
findings consistent with toxic megacolon.
- Patients actively enrolled on any other GVHD prevention trial.
- Any physical or psychological condition that, in the opinion of the investigator,
would post unacceptable risk to the patient or raise concern that the patient would
not comply with protocol procedures.
We found this trial at
1
site
Ann Arbor, Michigan 48109
Principal Investigator: Pavan Reddy, MD
Phone: 734-936-8785
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