Evaluating the Effects of Propionate and Butyrate Supplementation on the Intestinal Health of Healthy Volunteers
Graft Versus Host Disease · Hematopoietic and Lymphatic System Neoplasm · Malignant Solid Neoplasm
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Interventional
- Phase
- Phase 1
- Age range
- 18 years - 75 years
- Sex eligible
- All sexes
- Healthy volunteers
- Accepted
- Participants
- 12 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.
Read the full description
PRIMARY OBJECTIVE:
I. To determine the feasibility of repeated microencapsulated propionate and butyrate (mPB) administration as assessed by compliance; ability to consume at least 75% of the scheduled doses on a weekly basis.
SECONDARY OBJECTIVES:
I. To determine the safety of repeated mPB administration. II. To estimate blood and stool levels of propionate and butyrate metabolite content with repeated administration of mPB.
III. To identify a feasible target dose (TD) of repeated mPB administration in transplant patients as determined by dosing adherence and pharmacokinetic measures in blood and stool of healthy volunteers.
OUTLINE:
Participants receive microencapsulated sodium propionate orally (PO) four times daily (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.
After completion of study intervention, participants are followed up for 1 week.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Not applicable
- Masking
- No masking
Supportive care (mPB)
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
Biospecimen Collection PROCEDURE
Undergo collection of blood samples
Microencapsulated Sodium Butyrate DRUG
Given PO
Microencapsulated Sodium Propionate DRUG
Given PO
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Subjects' ability to take at least 75% of the specified dose on a weekly basis (feasibility)
Time frame: During 2 week intervention period
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.
Secondary measures
Incidence of adverse events
Time frame: 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
Adverse events will be categorized by type, frequency, severity, attribution, onset, and duration. Safety summaries will inform dosing decisions.
blood and stool - Propionate content
Time frame: At baseline and up to 3 weeks
Longitudinal blood and stool concentrations of propionate will be analyzed relative to baseline using complementary modeling approaches. First, repeated measurements over time will be analyzed using linear mixed-effects models with subject-specific random effects to account for within-individual correlation and irregular sampling, allowing estimation of population-level temporal exposure patterns following dosing. Second, cumulative metabolite exposure from baseline will be summarized at the subject level using area-under-the-curve (AUC) metrics, calculated using the trapezoidal rule. These AUC measures provide an integrated summary of longitudinal exposure and will be used to characterize dose-exposure relationships and inter-individual variability. Exposure estimates derived from healthy volunteers will inform dose selection and optimization for subsequent studies in transplant patients.
blood and stool - Butyrate content
Time frame: At baseline and up to 3 weeks
Longitudinal blood and stool concentrations of butyrate will be analyzed relative to baseline using complementary modeling approaches. First, repeated measurements over time will be analyzed using linear mixed-effects models with subject-specific random effects to account for within-individual correlation and irregular sampling, allowing estimation of population-level temporal exposure patterns following dosing. Second, cumulative metabolite exposure from baseline will be summarized at the subject level using area-under-the-curve (AUC) metrics, calculated using the trapezoidal rule. These AUC measures provide an integrated summary of longitudinal exposure and will be used to characterize dose-exposure relationships and inter-individual variability. Exposure estimates derived from healthy volunteers will inform dose selection and optimization for subsequent studies in transplant patients.
Dosing adherence measures
Time frame: During 2 week intervention period
assessed by compliance
subject's ability to take at least 75% of the specified dose on a weekly basis
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
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1 locations
City of Hope Medical CenterDuarte, California, United StatesStatus unknown
Study team and timeline
- Lead sponsor
- City of Hope Medical Center
- Study start
- Jan 4, 2027 Estimated
- Primary completion
- Jun 30, 2027 Estimated
- Study completion
- Jun 30, 2027 Estimated
- First posted
- May 28, 2026 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
No central contact is listed. Check the locations and the official record.
Official study title
A Pilot Feasibility Study of Oral Administration of Microencapsulated Propionate and Butyrate in Healthy Volunteers
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026