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Evaluating the Effects of Propionate and Butyrate Supplementation on the Intestinal Health of Healthy Volunteers

NCT07611370 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-05-28

No results posted yet for this study

Summary

This clinical trial evaluates how propionate and butyrate supplementation alters intestinal health in healthy volunteers and whether it would be feasible to administer these supplements to patients undergoing allogeneic hematopoietic stem cell transplant in the future. Propionate and butyrate are short chain fatty acids naturally produced in the intestines during the fermentation of dietary fibers. Greater levels of propionate and butyrate may improve intestinal barrier function, and propionate specifically has been shown to modulate immunity, energy metabolism, and gut-brain communication. The protective effects of propionate and butyrate supplementation on intestinal health may be especially beneficial for patients undergoing donor stem cell transplant, as these patients can experience significant gastrointestinal injury during treatment. The results of this study may help researchers determine whether propionate and butyrate supplementation positively alters the gut microbiome and whether or not supplementation could be used in the future for patients undergoing a donor stem cell transplant.

Conditions

Interventions

PROCEDURE

Biospecimen Collection

Undergo collection of blood samples

DRUG

Microencapsulated Sodium Butyrate

Given PO

DRUG

Microencapsulated Sodium Propionate

Given PO

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • City of Hope Medical Center

    lead OTHER

Principal Investigators

  • Karamjeet S Sandhu · City of Hope Medical Center

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2027-06-30
Completion
2027-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07611370 on ClinicalTrials.gov