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Clinical trial exploring the diet-microbiome axis in allo-HCT patients

探索异基因 HCT 患者饮食-微生物组轴的临床试验

基本信息

批准号：
10241908
负责人：
MUNEESH TEWARI
金额：
$ 45.01万
依托单位：
UNIVERSITY OF MICHIGAN AT ANN ARBOR
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-09-01 至 2025-05-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10241908
关键词：
Acute Acute Graft Versus Host Disease Allogenic Bacteria Benign Bile Acids Bioinformatics Biological Biometry Butyrates Cell Therapy Clinic Clinical Clinical Data Clinical Trials Collection DNA Data Death Rate Development Diet Dietary Intervention Dietary Supplementation Digestive System Disorders Disease Enzymes Epithelial Cells Face Feces Gastrointestinal tract structure Hematological Disease Hematology Hematopoietic Stem Cell Transplantation Human Immunocompromised Host Immunosuppression Incidence Institution Intervention Intestines Joints Laboratories Life Malignant - descriptor Measurement Mediating Metabolism Metagenomics Microbe Mus Pathogenesis Patient-Focused Outcomes Patients Phase II Clinical Trials Pilot Projects Plasma Plasma Cells Play Potato Probiotics RNA Reporting Research Research Personnel Resistance Role Safety Savings Severities Severity of illness Specimen Starch T-Lymphocyte Technology Testing Tissues Translating Volatile Fatty Acids Work base bench to bedside cost dietary dietary manipulation epithelial injury fecal transplantation gastrointestinal gastrointestinal epithelium graft vs host disease gut bacteria gut microbiome gut microbiota host microbiota improved improved outcome intestinal epithelium member metabolome metabolomics microbial microbiome microbiome alteration microbiome composition microbiome therapeutics microbiota metabolites mortality mouse model new technology novel phase II trial pre-clinical prebiotics prophylactic safety and feasibility standard of care stool sample

项目摘要

PROJECT SUMMARY/ABSTRACT – PROJECT 4 Allogeneic hematopoietic stem cell transplantation (allo-HCT) is a potent form of cellular therapy that has the potential to cure malignant and benign hematological conditions. However, its utility is limited by the development of graft-versus-host disease (GVHD). GI GVHD is the principal cause of non- relapse mortality (NRM) after allo-HCT. Recent evidence has brought into focus the role played by the metabolites derived from host-microbiota interactions in the severity of GI GVHD. However, the biological mechanisms, clinical feasibility, and the impact of altering the GI microbial metabolites on GI GVHD remain unknown. Project 4 will focus on dietary manipulation of the microbiome-metabolomic axis via dietary supplementation with resistant potato starch (RPS) for mitigating GVHD in allo-HCT patients. This project encompasses an investigator initiated proof-of-concept clinical trial that has been developed to translate the preliminary data generated from Projects 1 and 3. This trial is being performed under an IND from the FDA. It includes serial biosample (stool and plasma) collection and analyses for the microbiota and metabolite alterations, informed by mechanistic studies from projects 1, 2, and 3. We will also combine these data with longitudinal measurement of molecules reflecting intestinal epithelial injury, collectively comprising discovery approaches to more comprehensively study the effects of RPS on the microbiome, its dependent metabolites and host in allo-HCT patients.

项目摘要/摘要-项目4