Graft Versus Host DiseasePhase 1NCT07611370
Evaluating the Effects of Propionate and Butyrate Supplementation on the Intestinal Health of Healthy Volunteers
A Phase 1 study testing Biospecimen Collection, Microencapsulated Sodium Butyrate and Microencapsulated Sodium Propionate in people with Graft Versus Host Disease and Hematopoietic and Lymphatic System Neoplasm, run by City of Hope Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Graft Versus Host Disease, Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
- What is being tested?
- Biospecimen Collection, Microencapsulated Sodium Butyrate and Microencapsulated Sodium Propionate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2026to 30 Jun 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
City of Hope Medical Center
Duarte, California, 91010
Karamjeet S. Sandhu, 626-218-2405, ksandhu@coh.org
Karamjeet S. Sandhu
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
- Conditions
- Graft Versus Host Disease, Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
- Being tested
- Biospecimen Collection, Microencapsulated Sodium Butyrate, Microencapsulated Sodium Propionate
- Medical subject headings
- Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection
Undergo collection of blood samples
Microencapsulated Sodium ButyrateDrug
Also called Microencapsulated Formulation-containing Sodium Butyrate, MSB
Given PO
Microencapsulated Sodium PropionateDrug
Also called Microencapsulated Formulation-containing Sodium Propionate
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (mPB) | Experimental | 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. Receives: Procedure: Biospecimen Collection; Drug: Microencapsulated Sodium Butyrate; Drug: Microencapsulated Sodium Propionate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjects' ability to take at least 75% of the specified dose on a weekly basis (feasibility)
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.
Measured: During 2 week intervention period
Secondary outcomes (4)
Incidence of adverse events
Adverse events will be categorized by type, frequency, severity, attribution, onset, and duration. Safety summaries will inform dosing decisions.
Measured: 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
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.
Measured: At baseline and up to 3 weeks
blood and stool - Butyrate content
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.
Measured: At baseline and up to 3 weeks
Dosing adherence measures
assessed by compliance
subject's ability to take at least 75% of the specified dose on a weekly basis
Measured: During 2 week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start30 Sep 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graft Versus Host DiseaseStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Karamjeet S Sandhu, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07611370
- Sponsor's protocol ID
- 25518
- Other IDs
- NCI-2026-03337, 25518, P30CA033572
- Status last verified
- May 2026
- First submitted
- 14 May 2026
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Feasibility Study of Oral Administration of Microencapsulated Propionate and Butyrate in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT07611370
- Acronym / sponsor ID
- 25518
- Conditions
- Graft Versus Host Disease, Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 28 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (mPB) | Experimental | Procedure: Biospecimen Collection, Drug: Microencapsulated Sodium Butyrate, Drug: Microencapsulated Sodium PropionateParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen CollectionUndergo collection of blood samples | Procedure or surgery | Supportive care (mPB) |
| Microencapsulated Sodium ButyrateAlso: Microencapsulated Formulation-containing Sodium Butyrate, MSBGiven PO | Drug | Supportive care (mPB) |
| Microencapsulated Sodium PropionateAlso: Microencapsulated Formulation-containing Sodium PropionateGiven PO | Drug | Supportive care (mPB) |
Primary outcome
Subjects' ability to take at least 75% of the specified dose on a weekly basis (feasibility)
Time frame: 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.
4 secondary outcomes
Incidence of adverse events
Time frame: 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
Time frame: At baseline and up to 3 weeks
blood and stool - Butyrate content
Time frame: At baseline and up to 3 weeks
Dosing adherence measures
Time frame: During 2 week intervention period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Karamjeet S Sandhu principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Biospecimen Collection, Microencapsulated Sodium Butyrate and Microencapsulated Sodium Propionate in people with Graft Versus Host Disease and Hematopoietic and Lymphatic System Neoplasm, run by City of Hope Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjects' ability to take at least 75% of the specified dose on a weekly basis (feasibility) (time frame: During 2 week intervention period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.