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

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.

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