NCT03516461

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

January 7, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 4, 2018

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

March 30, 2025

Status Verified

September 1, 2024

Enrollment Period

7.5 years

First QC Date

January 7, 2018

Last Update Submit

March 27, 2025

Conditions

Radiation Enteritis

Keywords

Gut MicrobiotaRadiation EnteritisFecal Microbiota Transplantation

Outcome Measures

Primary Outcomes (1)

  • Clinical response rate

    The clinical response rate at 8 weeks after fmt treatment

    12 weeks

Secondary Outcomes (2)

  • Scores of gastrointestinal symptoms

    4, 8, 12 weeks

  • Change of toxicity grade

    4, 8, 12 weeks

Study Arms (2)

Fecal Microbiota Transplantation (FMT)

EXPERIMENTAL

Patients receive a course of FMT during hospitalization

Procedure: Fecal Microbiota Transplantation (FMT)

Basic treatment

NO INTERVENTION

Patient receives basic therapy for RE during hospitalization

Interventions

Fecal Microbiota Transplantation (FMT)PROCEDURE

Fecal microbiota transplantation for patients via nasointestinal tube or gastroscopy or colonic TET tube

Also known as: FMT
Fecal Microbiota Transplantation (FMT)

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age ≥18 years old;
  • Radiation enteritis diagnosed by colonoscopy after finishing radiotherapy.

You may not qualify if:

  • Patients who were pregnant or nursing;
  • Patients who were unable or unwilling to undergo a gastroscopy;
  • Patients who had gastrointestinal infection;
  • Patients with cardiopulmonary failure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210011, China

RECRUITING

Related Publications (12)

  • Cui M, Xiao H, Li Y, Zhou L, Zhao S, Luo D, Zheng Q, Dong J, Zhao Y, Zhang X, Zhang J, Lu L, Wang H, Fan S. Faecal microbiota transplantation protects against radiation-induced toxicity. EMBO Mol Med. 2017 Apr;9(4):448-461. doi: 10.15252/emmm.201606932.

    PMID: 28242755BACKGROUND

  • Borody TJ, Khoruts A. Fecal microbiota transplantation and emerging applications. Nat Rev Gastroenterol Hepatol. 2011 Dec 20;9(2):88-96. doi: 10.1038/nrgastro.2011.244.

    PMID: 22183182BACKGROUND

  • Cui B, Feng Q, Wang H, Wang M, Peng Z, Li P, Huang G, Liu Z, Wu P, Fan Z, Ji G, Wang X, Wu K, Fan D, Zhang F. Fecal microbiota transplantation through mid-gut for refractory Crohn's disease: safety, feasibility, and efficacy trial results. J Gastroenterol Hepatol. 2015 Jan;30(1):51-8. doi: 10.1111/jgh.12727.

    PMID: 25168749BACKGROUND

  • Ferreira MR, Muls A, Dearnaley DP, Andreyev HJ. Microbiota and radiation-induced bowel toxicity: lessons from inflammatory bowel disease for the radiation oncologist. Lancet Oncol. 2014 Mar;15(3):e139-47. doi: 10.1016/S1470-2045(13)70504-7.

    PMID: 24599929BACKGROUND

  • Zhang F, Cui B, He X, Nie Y, Wu K, Fan D; FMT-standardization Study Group. Microbiota transplantation: concept, methodology and strategy for its modernization. Protein Cell. 2018 May;9(5):462-473. doi: 10.1007/s13238-018-0541-8. Epub 2018 Apr 24.

    PMID: 29691757BACKGROUND

  • Manichanh C, Varela E, Martinez C, Antolin M, Llopis M, Dore J, Giralt J, Guarner F, Malagelada JR. The gut microbiota predispose to the pathophysiology of acute postradiotherapy diarrhea. Am J Gastroenterol. 2008 Jul;103(7):1754-61. doi: 10.1111/j.1572-0241.2008.01868.x. Epub 2008 Jun 28.

    PMID: 18564125BACKGROUND

  • Wang A, Ling Z, Yang Z, Kiela PR, Wang T, Wang C, Cao L, Geng F, Shen M, Ran X, Su Y, Cheng T, Wang J. Gut microbial dysbiosis may predict diarrhea and fatigue in patients undergoing pelvic cancer radiotherapy: a pilot study. PLoS One. 2015 May 8;10(5):e0126312. doi: 10.1371/journal.pone.0126312. eCollection 2015.

    PMID: 25955845BACKGROUND

  • Kim YS, Kim J, Park SJ. High-throughput 16S rRNA gene sequencing reveals alterations of mouse intestinal microbiota after radiotherapy. Anaerobe. 2015 Jun;33:1-7. doi: 10.1016/j.anaerobe.2015.01.004. Epub 2015 Jan 16.

    PMID: 25600706BACKGROUND

  • Delia P, Sansotta G, Donato V, Messina G, Frosina P, Pergolizzi S, De Renzis C, Famularo G. Prevention of radiation-induced diarrhea with the use of VSL#3, a new high-potency probiotic preparation. Am J Gastroenterol. 2002 Aug;97(8):2150-2. doi: 10.1111/j.1572-0241.2002.05946.x. No abstract available.

    PMID: 12190202BACKGROUND

  • Demers M, Dagnault A, Desjardins J. A randomized double-blind controlled trial: impact of probiotics on diarrhea in patients treated with pelvic radiation. Clin Nutr. 2014 Oct;33(5):761-7. doi: 10.1016/j.clnu.2013.10.015. Epub 2013 Oct 24.

    PMID: 24200199BACKGROUND

  • Nascimento M, Aguilar-Nascimento JE, Caporossi C, Castro-Barcellos HM, Motta RT. Efficacy of synbiotics to reduce acute radiation proctitis symptoms and improve quality of life: a randomized, double-blind, placebo-controlled pilot trial. Int J Radiat Oncol Biol Phys. 2014 Oct 1;90(2):289-95. doi: 10.1016/j.ijrobp.2014.05.049.

    PMID: 25304789BACKGROUND

  • Ding X, Li Q, Li P, Chen X, Xiang L, Bi L, Zhu J, Huang X, Cui B, Zhang F. Fecal microbiota transplantation: A promising treatment for radiation enteritis? Radiother Oncol. 2020 Feb;143:12-18. doi: 10.1016/j.radonc.2020.01.011. Epub 2020 Feb 7.

    PMID: 32044171DERIVED

MeSH Terms

Interventions

Fecal Microbiota Transplantation

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeutics

Study Officials

  • Faming Zhang, MD; PHD

    The Second Hospital of Nanjing Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Faming Zhang, MD; PHD

CONTACT

086-25-58509883fzhang@njmu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Microbiota Medicine, Gastroenterology

Study Record Dates

First Submitted

January 7, 2018

First Posted

May 4, 2018

Study Start

January 7, 2018

Primary Completion

July 1, 2025

Study Completion

July 1, 2025

Last Updated

March 30, 2025

Record last verified: 2024-09

Locations

CN(1)