Supercharged poop pills aim to heal radiation gut damage
NCT ID NCT07331688
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding a special bacterial strain (CMTS0515) to a standard fecal transplant can better relieve gut symptoms caused by radiation therapy for cancer. Sixty adults who completed radiation for abdominal or pelvic cancer will receive either the enhanced or standard transplant via a tube into the intestine. The main goal is to see if the enhanced version is at least as good as the standard at reducing radiation injury scores.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- fecal microbiota transplant (enhanced with CMTS0515)
- What this could lead to
- If it works, this could offer a better way to manage chronic gut problems caused by radiation therapy, improving quality of life for cancer survivors.
- What could go wrong
- This is an early-phase trial with only 60 participants, so results may not apply to everyone. The treatment involves transplanting donor bacteria, which carries a small risk of infection or unexpected side effects.
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
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Dec 2030
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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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 Hide 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: 1. Histopathologically confirmed diagnosis of abdominal or pelvic cancer; 2. Completion of at least one entire course of radiation therapy; 3. Age ≥18 years at the time of cancer diagnosis. Exclusion Criteria: 1. Absence of intestinal symptoms or transient intestinal symptoms; 2. Radiation treatment involving areas outside the abdomen and pelvis; 3. Diagnosis of antibiotic-associated diarrhea or use of antibiotics within four weeks before enrollment; 4. Presence of intestinal comorbidities, including inflammatory bowel disease or pseudomembranous colitis; 5. Presence of severe conditions rendering the patient unsuitable for inclusion; 6. Experience of bowel surgery for RE-associated fistula.
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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.
Contacts and locations
Locations
-
Department of Microbiota Medicine & Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210011, China
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