Evaluating the Effects of Propionate and Butyrate Supplementation on the Intestinal Health of Healthy Volunteers

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCity of Hope Medical Center

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Biospecimen Collection
  • Microencapsulated Sodium Butyrate
  • Microencapsulated Sodium Propionate

Treatment groups

12 Participants
are divided into 1 treatment group

Sponsors and collaborators

City of Hope Medical Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator