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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2026-03337 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 25518 | Other Identifier | City of Hope Medical Center | |
| P30CA033572 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biospecimen Collection | Procedure | Undergo collection of blood samples |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | Adverse events will be categorized by type, frequency, severity, attribution, onset, and duration. Safety summaries will inform dosing decisions. | 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 |
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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)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karamjeet S Sandhu | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | 91010 | United States |
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| Microencapsulated Sodium Butyrate | Drug | Given PO |
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| Microencapsulated Sodium Propionate | Drug | Given PO |
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| 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. | At baseline and up to 3 weeks |
| 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. | At baseline and up to 3 weeks |
| Dosing adherence measures | assessed by compliance subject's ability to take at least 75% of the specified dose on a weekly basis | During 2 week intervention period |
| ID | Term |
|---|---|
| D006086 | Graft vs Host Disease |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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