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Radiation EnteritisNCT03516461

Fecal Microbiota Transplantation for Radiation Enteritis

A study testing Fecal Microbiota Transplantation (FMT) in people with Radiation Enteritis, run by The Second Hospital of Nanjing Medical University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Radiation Enteritis
What is being tested?
Fecal Microbiota Transplantation (FMT)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteChina
Study dates
7 Jan 2018to 1 Jul 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Faming Zhang, MD; PHD contact

086-25-58509883

fzhang@njmu.edu.cn

China1 site, 1 recruiting

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

    Nanjing, Jiangsu, 210011

    Faming Zhang, MD, PhD, 086-25-58509883, fzhang@njmu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: Efficacy and Safety of Fecal Microbiota Transplantation in Radiation Enteritis

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.

Read the 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.

Being tested
Fecal Microbiota Transplantation (FMT)
Keywords
Gut Microbiota, Radiation Enteritis, Fecal Microbiota Transplantation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fecal Microbiota Transplantation (FMT)Procedure or surgery

    Also called FMT

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

Study groups in NCT03516461
Study groupRoleWhat they receive
Fecal Microbiota Transplantation (FMT)ExperimentalPatients receive a course of FMT during hospitalization
Receives: Procedure: Fecal Microbiota Transplantation (FMT)
Basic treatmentNo interventionPatient receives basic therapy for RE during hospitalization

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical response rate

    The clinical response rate at 8 weeks after fmt treatment

    Measured: 12 weeks

Secondary outcomes (2)

  1. Scores of gastrointestinal symptoms

    Gastrointestinal symptoms will be evaluated according to NCI-CTC 5.0

    Measured: 4, 8, 12 weeks

  2. Change of toxicity grade

    The change of toxicity grade according to the RTOG/EORTC toxicity scale at 4, 8, 12 weeks after FMT

    Measured: 4, 8, 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2018
  2. Study start7 Jan 2018
  3. Primary completion1 Jul 2025 (estimated)
  4. Study completion1 Jul 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03516461
Sponsor's protocol ID
FMT-RE-201702
Status last verified
Sep 2024
First submitted
7 Jan 2018
Last updated
30 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 28242755

  • 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.

    PubMed 22183182

  • 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.

    PubMed 25168749

  • 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.

    PubMed 24599929

  • 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.

    PubMed 29691757

  • 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.

    PubMed 18564125

  • 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.

    PubMed 25955845

  • 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.

    PubMed 25600706

  • 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.

    PubMed 12190202

  • 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.

    PubMed 24200199

  • 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.

    PubMed 25304789

  • 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.

    PubMed 32044171

Questions about this trial

What is this clinical trial studying?

A study testing Fecal Microbiota Transplantation (FMT) in people with Radiation Enteritis, run by The Second Hospital of Nanjing Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Faming Zhang, MD; PHD (086-25-58509883, fzhang@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical response rate (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03516461, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.

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