Evaluating the Effects of Propionate and Butyrate Supplementation on the Intestinal Health of Healthy Volunteers
20 de mayo de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
12
Fase
- Fase 1
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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California
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Duarte, California, Estados Unidos, 91010
- City of Hope Medical Center
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Contacto:
- Karamjeet S. Sandhu
- Número de teléfono: 626-218-2405
- Correo electrónico: ksandhu@coh.org
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Investigador principal:
- Karamjeet S. Sandhu
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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.
|
Someterse a la recolección de muestras de sangre.
Otros nombres:
Given PO
Otros nombres:
Given PO
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Subjects' ability to take at least 75% of the specified dose on a weekly basis (feasibility)
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Incidence of adverse events
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Karamjeet S Sandhu, City of Hope Medical Center
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
30 de septiembre de 2026
Finalización primaria (Estimado)
30 de junio de 2027
Finalización del estudio (Estimado)
30 de junio de 2027
Fechas de registro del estudio
Enviado por primera vez
14 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
20 de mayo de 2026
Publicado por primera vez (Actual)
28 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
28 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
20 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 25518 (Otro identificador: City of Hope Medical Center)
- P30CA033572 (Subvención/contrato del NIH de EE. UU.)
- NCI-2026-03337 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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