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

NCT07611370 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 3 other identifiers: 25518NCI-2026-03337P30CA033572
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Graft Versus Host Disease; Hematopoietic and Lymphatic System Neoplasm; Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (1)

• Subjects' ability to take at least 75% of the specified dose on a weekly basis (feasibility)

  Evaluated by assessment of subject's ability to take at least 75% of the specified dose on a weekly basis. Vomiting within an hour after taking a dose will be considered a missed dose. Participants who do not meet this criterion will be considered as feasibility failure.

  During 2 week intervention period

Secondary Outcomes (4)

• Incidence of adverse events

  From the first dose of microencapsulated sodium propionate to the first observation of toxicities or by day +7 after the last dose of microencapsulated propionate and butyrate

• blood and stool - Propionate content

  At baseline and up to 3 weeks

• blood and stool - Butyrate content

  At baseline and up to 3 weeks

• Dosing adherence measures

  During 2 week intervention period

Study Arms (1)

Supportive care (mPB)

EXPERIMENTAL

Participants receive microencapsulated sodium propionate PO QID for 1 week. Participants then receive microencapsulated sodium propionate PO QID and microencapsulated sodium butyrate PO QID for 1 week. Participants also undergo collection of blood samples throughout the study.

Procedure: Biospecimen Collection; Drug: Microencapsulated Sodium Butyrate; Drug: Microencapsulated Sodium Propionate

Interventions

Biospecimen Collection PROCEDURE

Undergo collection of blood samples

Also known as: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

Supportive care (mPB)

Microencapsulated Sodium Butyrate DRUG

Given PO

Also known as: Microencapsulated Formulation-containing Sodium Butyrate, MSB

Supportive care (mPB)

Microencapsulated Sodium Propionate DRUG

Given PO

Also known as: Microencapsulated Formulation-containing Sodium Propionate

Supportive care (mPB)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented informed consent of the participant and/or legally authorized representative
• Age: ≥ 18 years and ≤ 75 years old
• Ability to read and understand and willingness to sign a written informed consent
• Ability to understand English to fill out required forms (e.g. Pill Diary and Symptom Diary)
• Participants are not taking butyrate or propionate as supplement(s)
• Those who are already taking butyrate or propionate as supplement(s) are allowed only if they are willing to stop the supplement(s) ≥ 7 days prior to baseline samples and for the duration of this study

You may not qualify if:

• History of migraines and chronic gastrointestinal diseases, such as inflammatory bowel disease or Crohn's disease
• History of allergic reactions to compounds of similar chemical or biologic composition to study agent
• Females only: Pregnant, breastfeeding, or planning to get pregnant
• Antibiotic exposure within 2 weeks prior to day 1 of study

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

Specimen Handling

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Karamjeet S Sandhu

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: May 28, 2026
• Study Start (Estimated): September 30, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: May 28, 2026

Record last verified: 2026-05

Locations

US (1)