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NCT03516461
Fecal Microbiota Transplantation for Radiation Enteritis
NA trial testing Fecal Microbiota Transplantation (FMT) in Radiation Enteritis in 70 participants. Currently enrolling.
1 July 2025
Quick facts
| Lead sponsor | The Second Hospital of Nanjing Medical University |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 70 |
| Start date | 7 January 2018 |
| Primary completion | 1 July 2025 |
| Estimated completion | 1 July 2025 |
| Sites | 1 location across China |
Drugs / interventions tested
- Fecal Microbiota Transplantation (FMT) — full drug profile →
Conditions studied
- Radiation Enteritis — all drugs for Radiation Enteritis →
Sponsor
The Second Hospital of Nanjing Medical University
Who can join
Adults 18 to 85, any sex, with Radiation Enteritis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Radiation enteritis is one of the most feared complications after abdominal or pelvic radiation therapy.The gut microbiota is considered to constitute a "microbial organ" which has pivotal roles in the intestinal diseases and body metabolism. Evidence from animal studies demonstrated the link between intestinal bacteria and radiation enteritis. This clinical trial aims to evaluate the efficacy and safety of fecal microbiota transplantation (FMT) for radiation enteritis.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Fecal microbiota transplantation: A promising treatment for radiation enteritis?
Ding X, Li Q, Li P, Chen X, et al · · 2020 · cited 100× · PMID 32044171 · DOI 10.1016/j.radonc.2020.01.011 -
Acute Radiation Syndrome and the Microbiome: Impact and Review.
Hollingsworth BA, Cassatt DR, DiCarlo AL, Rios CI, et al · · 2021 · cited 42× · PMID 34084131 · DOI 10.3389/fphar.2021.643283 -
Novel directions of precision oncology: circulating microbial DNA emerging in cancer-microbiome areas.
You L, Zhou J, Xin Z, Hauck JS, et al · · 2022 · cited 23× · PMID 35692444 · DOI 10.1093/pcmedi/pbac005 -
Microbiota modification in hematology: still at the bench or ready for the bedside?
Severyn CJ, Brewster R, Andermann TM. · · 2019 · cited 22× · PMID 31714965 · DOI 10.1182/bloodadvances.2019000365 -
UEG Week 2019 Poster Presentations.
· 2019 · cited 5× · PMID 32213001 · DOI 10.1177/2050640619854671 -
Microbiota modification in hematology: still at the bench or ready for the bedside?
Severyn CJ, Brewster R, Andermann TM. · · 2019 · cited 5× · PMID 31808861 · DOI 10.1182/hematology.2019000365 -
Microbiome profiling and Co-metabolism pathway analysis in cervical cancer patients with acute radiation enteritis.
Ma CY, Zhao J, Zhou JY. · · 2024 · cited 3× · PMID 38655340 · DOI 10.1016/j.heliyon.2024.e29598 -
Radiation-induced intestinal injury: from molecular mechanisms to clinical translation.
Wu W, Cai Y, Yang Z, Chen M, et al · · 2025 · cited 1× · PMID 40951837 · DOI 10.3389/or.2025.1613704
Verify or expand the search:
- PubMed search for NCT03516461
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Fecal Microbiota Transplantation (FMT)
Trials testing the same drug.
- NCT05373784 — FMT in Uncomplicated Diverticulitis · EARLY_PHASE1 · active not recruiting
- NCT05911997 — MTC Versus FMT in for RCDI · Phase 1 · recruiting
- NCT05273255 — Fecal Microbiota Transplantation in Patients With Malignancies Not Responding to Cancer Immunotherapy · NA · completed
- NCT04997733 — Fecal Microbiota Transplantation in Crohn's Disease as Relay After Anti-TNF Withdrawal · Phase 3 · recruiting
- NCT04124211 — Fecal Microbiome Transplantation (FMT) for Type 1 Diabetes · NA · unknown
Other recruiting trials for Radiation Enteritis
Currently open trials in the same condition.
- NCT07331688 — CMTS0515-auWMT for Radiation Enteritis · Phase 1, PHASE2 · active not recruiting
- NCT06617182 — Efficacy and Safety of Thalidomide Combined With Glutamine in the Treatment of Radiation Intestinal Injury. · Phase 2 · recruiting
Other The Second Hospital of Nanjing Medical University trials
Trials by the same sponsor.
- NCT07331688 — CMTS0515-auWMT for Radiation Enteritis · Phase 1, PHASE2 · active not recruiting
- NCT06839586 — CMTS4520 for Chronic Diarrhoea in Adults · Phase 1, PHASE2 · active not recruiting
- NCT06839599 — CMTS4520-Assisted Washed Microbiota Transplantation for Chronic Diarrhoea in Adults · Phase 1, PHASE2 · not yet recruiting
- NCT06844708 — CMTS0929 for Inflammatory Bowel Disease · EARLY_PHASE1 · not yet recruiting
- NCT06836427 — CMTS0929 for Clostridioides Difficile Infection · EARLY_PHASE1 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03516461 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by The Second Hospital of Nanjing Medical University
- Last refreshed: 30 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03516461.
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