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.
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)
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
Single group
Biospecimen Collection
Procedure/SurgeryUndergo collection of blood samples
Microencapsulated Sodium Butyrate
DrugGiven PO
Microencapsulated Sodium Propionate
DrugGiven PO
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.
Incidence of adverse events
Adverse events will be categorized by type, frequency, severity, attribution, onset, and duration. Safety summaries will inform dosing decisions.
blood and stool - Propionate content
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
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
assessed by compliance subject's ability to take at least 75% of the specified dose on a weekly basis
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City of Hope Medical Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
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