Ignite Creation Date:
2024-05-06 @ 3:24 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04629430
Status:
COMPLETED
Last Update Posted:
2023-01-04
First Post:
2020-11-10
Brief Title:
Effects of Prebiotics on Gut Microbiome in Patients Undergoing HSCT
Sponsor:
University of Virginia
Organization:
University of Virginia
Study Overview
Official Title:
Effects of Prebiotics on Gut Microbiome in Patients Undergoing Stem Cell Transplants
Status:
COMPLETED
Status Verified Date:
2023-01
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:
HCTDiet
Brief Summary:
The purpose of this study is to see whether hematopoietic stem cell transplant HSCT patients can consistently eat a diet rich in prebiotics This type of diet may be helpful in maintaining diversity in the gastrointestinal GI system and therefore potentially decreasing risk of other GI problems
Detailed Description:
Maintaining gastrointestinal GI microbiome diversity has been shown to improve treatment related mortality in HSCT patients Interventions to improve GI microbial diversity could be beneficial to this patient population Diets rich in prebiotics have been shown to increase gut microbial diversity and improve symptoms in other gastrointestinal diseases Prebiotics are non-digestible carbohydrates that promote growth of commensal organisms in the gut by providing nutrition Some examples are brown rice green apples and tomatoes Our theory is that consuming a diet rich in prebiotics pre- and during the first 100 days following HSCT will help to reduce acute graft versus host disease aGVHD overall and specifically acute GI GVHD and clostridium difficile CDiff Participants will be encouraged to eat at least 2 servings of a prebiotic-rich food from time of admission for HSCT through 100 days following HSCT and will be clinically monitored including for acute GVHD acute GI GVHD and CDiff Stool samples will be collected from all participants about once every 4 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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?:
None