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Could a simple supplement protect your gut during radiation?

NCT ID NCT04700527

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 04, 2026 · Updated 3 times

Summary

This study tests whether taking a short chain fatty acid supplement can reduce gut-related side effects in people receiving radiation therapy for cancers in the abdomen or pelvis. About 122 adults will be randomly assigned to receive either the supplement or a placebo. The goal is to see if this low-cost approach can improve quality of life during treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Short chain fatty acid (sodium butyrate and sodium propionate) supplement
What this could lead to
If it works, this could offer a simple, low-cost way to reduce gut-related side effects from radiation therapy, making treatment more tolerable.
What could go wrong
This is an early-phase trial with only 122 participants, so results may not be conclusive. The supplement might not reduce side effects better than a placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 122 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2023

Expected to finish

May 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information. Consent for the use of any residual material from biopsy and/or surgical resection (archival tissue) and serial blood draws will be required for enrollment. * ≥ 18 years of age on day of signing informed consent. * ECOG performance score ≤ 2 * Subjects with histological or cytological evidence/confirmation of GI, urologic or gynecologic malignancy (including sarcoma) that will be treated with minimum dose of 40Gy (equivalent dose in 2Gy per fraction or EQD2) via 3D conformal fields or IMRT to abdomen or pelvis (multimodality treatment with surgery, systemic anti cancer therapy is permissible) * Subjects may have had prior chemotherapy or surgery. * Subjects deemed healthy for study inclusion by the treating physician based on the laboratory values at screening and general health status. * Prior cancer treatment must be completed at least 14 days prior to registration and the subject must have recovered from all reversible acute toxic effects of the regimen (other than alopecia) to ≤ Grade 1 or baseline. * Females of childbearing potential must have a negative urine pregnancy test within 14 days prior to simulation. NOTE: Females are considered of childbearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least 12 consecutive months. Documentation of postmenopausal status must be provided. * Females of childbearing potential must be willing to abstain from heterosexual activity or to use 2 forms of effective methods of contraception from the time of informed consent until 14 or 28 days after treatment discontinuation. The two contraception methods can be comprised of two barrier methods, or a barrier method plus a hormonal method or an intrauterine device that meets \< 1% failure rate for protection from pregnancy in the product label. * Male subjects with female partners of childbearing potential must have had a prior vasectomy or agree to use an adequate method of contraception (i.e., double barrier method: condom plus spermicidal agent) starting with the first dose of study therapy through 14-28 days after the last dose of study therapy. * Subjects is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee. Exclusion Criteria: * Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study). * Prior abdominopelvic RT to a region with anticipated direct overlap with the present planned course of RT. * History of inflammatory bowel disease or GI motility disorder * Grade 2 or higher diarrhea at baseline unless deemed by the investigator to be caused by laxatives prescribed for symptomatic partial obstruction * Concurrent use of histone deacetylase inhibitors (vorinostat) * Baseline hypernatremia defined as serum sodium concentration \>145 mEg/L * Creatinine clearance \< 50 mL/min * Congestive heart failure * On a salt restricted diet for medical indications * Severe nut allergy * Active central nervous system (CNS) metastases * Subject must have completed treatment with any investigational drug other than the drugs in this study and subjects may not be on another clinical trial by no less than 14 days prior to registration. Subjects participating in interventional trials that does not include an investigational agent or any other drug are allowed at the discretion of the principal investigator. * Subject is receiving prohibited medications or treatments as listed in section 5.6 of the protocol that cannot be discontinued/replaced by an alternative therapy.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Flora Danquah

    RECRUITING

    Chapel Hill, North Carolina, 27599, United States

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