Clinical trial · Interventional
Evaluating the Effects of Propionate and Butyrate Supplementation on the Intestinal Health of Healthy Volunteers
A Pilot Feasibility Study of Oral Administration of Microencapsulated Propionate and Butyrate in Healthy Volunteers
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Graft Versus Host Disease | — | UNRESOLVED | — |
| Hematopoietic and Lymphatic System Neoplasm | Hematopoietic and Lymphatic System Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Malignant Solid Neoplasm | Malignant Solid Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Microencapsulated Sodium Butyrate | Drug | — | UNRESOLVED |
| Microencapsulated Sodium Propionate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Supportive care (mPB)
- description
- 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.
- interventionNames
- Procedure: Biospecimen Collection
- Drug: Microencapsulated Sodium Butyrate
- Drug: Microencapsulated Sodium Propionate
Primary outcomes (1)
- measure
- Subjects' ability to take at least 75% of the specified dose on a weekly basis (feasibility)
- timeFrame
- During 2 week intervention period
- description
- 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 outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available