Evaluating the Effects of Propionate and Butyrate Supplementation on the Intestinal Health of Healthy Volunteers
2026年5月20日 更新者：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.
調査の概要
状態
まだ募集していません
詳細な説明
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.
研究の種類
介入
入学 (推定)
12
段階
- フェーズ 1
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
California
-
Duarte、California、アメリカ、91010
- City of Hope Medical Center
-
コンタクト：
- Karamjeet S. Sandhu
- 電話番号：626-218-2405
- メール：ksandhu@coh.org
-
主任研究者：
- Karamjeet S. Sandhu
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
はい
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
血液サンプルの採取を受ける
他の名前：
Given PO
他の名前：
Given PO
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Subjects' ability to take at least 75% of the specified dose on a weekly basis (feasibility)
時間枠：During 2 week intervention period
|
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.
|
During 2 week intervention period
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence of adverse events
時間枠：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
|
Adverse events will be categorized by type, frequency, severity, attribution, onset, and duration.
Safety summaries will inform dosing decisions.
|
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
時間枠：At baseline and up to 3 weeks
|
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.
|
At baseline and up to 3 weeks
|
|
blood and stool - Butyrate content
時間枠：At baseline and up to 3 weeks
|
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.
|
At baseline and up to 3 weeks
|
|
Dosing adherence measures
時間枠：During 2 week intervention period
|
assessed by compliance subject's ability to take at least 75% of the specified dose on a weekly basis |
During 2 week intervention period
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Karamjeet S Sandhu、City of Hope Medical Center
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年9月30日
一次修了 (推定)
2027年6月30日
研究の完了 (推定)
2027年6月30日
試験登録日
最初に提出
2026年5月14日
QC基準を満たした最初の提出物
2026年5月20日
最初の投稿 (実際)
2026年5月28日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月28日
QC基準を満たした最後の更新が送信されました
2026年5月20日
最終確認日
2026年5月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。