Fecal Microbiota Transplantation for Radiation Enteritis

NCT ID: NCT03516461

Last Updated: 2025-03-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-07
• Study Completion Date: 2025-07-01

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.

Detailed Description

The present clinical trial aims to re-establish a gut functionality state of intestinal microbiota through fecal microbiota transplantation (FMT) for radiation enteritis (RE). FMT is the whole profile of fecal microbiota transplantation. At enrollment, "Shared Decision Making" intervention was applied to support patient involvement in making health decisions. Patients have opportunity to choose fecal microbiota transplantation (FMT). Patients will receive follow-up for at least 12 weeks. Blood test, endoscopy and questionnaire will be used to access participants at study start and at study completion. Fecal microbiota compositions, blood and urinary metabolic profiles of patients will be analyzed to assess associated microbial changes.

Conditions

Radiation Enteritis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fecal Microbiota Transplantation (FMT)

Patients receive a course of FMT during hospitalization

Group Type: EXPERIMENTAL

Fecal Microbiota Transplantation (FMT)

Intervention Type: PROCEDURE

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

Basic treatment

Patient receives basic therapy for RE during hospitalization

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Fecal Microbiota Transplantation (FMT)

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

Intervention Type: PROCEDURE

Other Intervention Names

FMT

Eligibility Criteria

Inclusion Criteria

1. age ≥18 years old;

2. Radiation enteritis diagnosed by colonoscopy after finishing radiotherapy.

Exclusion Criteria

1. Patients who were pregnant or nursing;

2. Patients who were unable or unwilling to undergo a gastroscopy;

3. Patients who had gastrointestinal infection;

4. Patients with cardiopulmonary failure.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangxi Provincial Cancer Hospital

OTHER

Sponsor Role: collaborator

The Second Hospital of Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Faming Zhang

Professor, Microbiota Medicine, Gastroenterology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Faming Zhang, MD; PHD

Role: PRINCIPAL_INVESTIGATOR

The Second Hospital of Nanjing Medical University

Locations

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

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Faming Zhang, MD; PHD

Role: CONTACT

fzhang@njmu.edu.cn

086-25-58509883

Facility Contacts

Faming Zhang, MD, PhD

Role: primary

fzhang@njmu.edu.cn

086-25-58509883

References

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.

Reference Type: BACKGROUND

PMID: 28242755 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22183182 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25168749 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24599929 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29691757 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18564125 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25955845 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25600706 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12190202 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24200199 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25304789 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32044171 (View on PubMed)

Other Identifiers

FMT-RE-201702

Identifier Type: -

Identifier Source: org_study_id