Evaluating the Effects of Propionate and Butyrate Supplementation on the Intestinal Health of Healthy Volunteers
20 mai 2026 mis à jour par: City of Hope Medical Center
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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
12
Phase
- La phase 1
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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California
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Duarte, California, États-Unis, 91010
- City of Hope Medical Center
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Contact:
- Karamjeet S. Sandhu
- Numéro de téléphone: 626-218-2405
- E-mail: ksandhu@coh.org
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Chercheur principal:
- Karamjeet S. Sandhu
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Oui
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Supportive care (mPB)
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.
|
Subir une collecte d'échantillons de sang
Autres noms:
Given PO
Autres noms:
Given PO
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Subjects' ability to take at least 75% of the specified dose on a weekly basis (feasibility)
Délai: During 2 week intervention period
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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.
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During 2 week intervention period
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Incidence of adverse events
Délai: 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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Adverse events will be categorized by type, frequency, severity, attribution, onset, and duration.
Safety summaries will inform dosing decisions.
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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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blood and stool - Propionate content
Délai: At baseline and up to 3 weeks
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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.
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At baseline and up to 3 weeks
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blood and stool - Butyrate content
Délai: At baseline and up to 3 weeks
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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.
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At baseline and up to 3 weeks
|
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Dosing adherence measures
Délai: During 2 week intervention period
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assessed by compliance subject's ability to take at least 75% of the specified dose on a weekly basis |
During 2 week intervention period
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Karamjeet S Sandhu, City of Hope Medical Center
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
30 septembre 2026
Achèvement primaire (Estimé)
30 juin 2027
Achèvement de l'étude (Estimé)
30 juin 2027
Dates d'inscription aux études
Première soumission
14 mai 2026
Première soumission répondant aux critères de contrôle qualité
20 mai 2026
Première publication (Réel)
28 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
28 mai 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
20 mai 2026
Dernière vérification
1 mai 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 25518 (Autre identifiant: City of Hope Medical Center)
- P30CA033572 (Subvention/contrat des NIH des États-Unis)
- NCI-2026-03337 (Identificateur de registre: CTRP (Clinical Trial Reporting Program))
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Oui
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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