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NCT06776029

Fecal Microbiota Transplantation for Radiation-Induced Proctopathy

Recruiting now Phase 2 Last updated 10 March 2025
What this trial tests

Phase 2 trial testing Fecal Microbiota Transplantation Capsule in Radiation Induced Proctitis in 20 participants. Currently enrolling.

Timeline
1 February 2025
Primary endpoint
31 March 2026
30 June 2026

Quick facts

Lead sponsorSixth Affiliated Hospital, Sun Yat-sen University
PhasePhase 2
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment20
Start date1 February 2025
Primary completion31 March 2026
Estimated completion30 June 2026
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Who can join

Adults 18 to 75, any sex, with Radiation Induced Proctitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of this single-arm trial is to learn if Fecal Microbiota Transplantation (FMT) works to treat hemorrhagic radiation-induced proctopathy. The main questions it aims to answer are: * Dose FMT alleviate the symptom of severe rectal bleeding? * Dose FMT improve the endoscopic findings of proctopathy? Participants will: * Take fecal microbiota capsules by 8 sessions over a 12-week period. * Visit the clinic once every 4 weeks for checkups and tests. * Keep a diary of their symptoms and the number of times they use other supportive care.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Radiomitigators: Breakthroughs in Post-Radiation Recovery.
    Obrador E, Estrela JM, López-Blanch R, Moreno-Murciano P, et al · · 2026 · PMID 41897526 · DOI 10.3390/antiox15030381

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Other trials of Fecal Microbiota Transplantation Capsule

Trials testing the same drug.

Other Sixth Affiliated Hospital, Sun Yat-sen University trials

Trials by the same sponsor.

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Data sources for this page

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