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Набор скоро начнётся NCT07611370

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

Фаза I С лечением Graft Versus Host Disease Hematopoietic and Lymphatic System Neoplasm Malignant Solid Neoplasm

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Biospecimen Collection, Microencapsulated Sodium Butyrate, Microencapsulated Sodium Propionate.
Кому может быть актуально
Состояния в реестре: Graft Versus Host Disease, Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm. Базовые параметры: 18 лет — 75 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

A Pilot Feasibility Study of Oral Administration of Microencapsulated Propionate and Butyrate in Healthy Volunteers

Обзор

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.

Подробное описание

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.

Вмешательства

  • Процедура Biospecimen Collection
    Undergo collection of blood samples
  • Препарат Microencapsulated Sodium Butyrate
    Given PO
  • Препарат Microencapsulated Sodium Propionate
    Given PO

Первичные конечные точки

  • Subjects' ability to take at least 75% of the specified dose on a weekly basis (feasibility) [Срок оценки: During 2 week intervention period]
Вторичные конечные точки (4)
  • Incidence of adverse events [Срок оценки: 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]
  • blood and stool - Propionate content [Срок оценки: At baseline and up to 3 weeks]
  • blood and stool - Butyrate content [Срок оценки: At baseline and up to 3 weeks]
  • Dosing adherence measures [Срок оценки: During 2 week intervention period]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

США · 1 центр
  • City of Hope Medical Center — Duarte

Идентификаторы

NCT: NCT07611370 · 25518 · NCI-2026-03337 · 25518 · P30CA033572

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗