Microbiota Transplantation for Radiation Enteritis

Radiation Enteritis Clinical Trial

Official title:

Efficacy and Safety of Selective Microbiota Transplantation and Fecal Microbiota Transplantation in Radiation Enteritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03516461
• Other study ID #: SMT-YJ-201702
• Status: Recruiting
• Phase: N/A
• Start date: January 7, 2018
• Est. completion date: December 2020

Study information

• Verified date: October 2019
• Source: The Second Hospital of Nanjing Medical University
• Contact: Faming Zhang, MD; PHD
• Phone: 086-25-58509883
• Email: fzhang[@]njmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Evidence from animal studies demonstrated the link between intestinal bacteria and radiation enteritis. This clinical trial aims to evaluate the efficacy and safety of selective microbiota transplantation (SMT) and fecal microbiota transplantation (FMT) for radiation enteritis.

Description:

The present clinical trial aims to re-establish a gut functionality state of intestinal flora through selective microbiota transplantation (SMT) or fecal microbiota transplantation (FMT) for radiation enteritis (RE). FMT is the whole profile of fecal microbiota transplantation. SMT is the intermediate composition of bacteria between traditional probiotics and whole profile of microbiota; it aims to stimulate the efficiency 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 selective microbiota transplantation (SMT) or fecal microbiota transplantation (FMT). Patients will receive follow-up for at least 4 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Enteritis
• Radiation Enteritis

Intervention

Procedure:
• Selective Microbiota Transplantation (SMT)
Selective microbiota transplantation for patients via nasointestinal tube (once per day for 3 days)
• Fecal Microbiota Transplantation (FMT)
Fecal microbiota transplantation for patients via nasointestinal tube or gastroscopy (once per day and no more than 3 times)

Locations

Country	Name	City	State
China	Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
The Second Hospital of Nanjing Medical University	Fuzhou General Hospital

Country where clinical trial is conducted

China, 

References & Publications (11)

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Manichanh C, Varela E, Martinez C, Antolin M, Llopis M, Doré 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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of toxicity grade	The change of toxicity grade according to the RTOG/EORTC toxicity scale at 4 weeks after SMT	4 weeks
Secondary	Scores of gastrointestinal symptoms	Gastrointestinal symptoms will be evaluated according to NCI-CTC 5.0	4 weeks
Secondary	Karnofsky Performance Status (KPS) scale	Changes in functional status of patients will be assessed according to the Karnofsky Performance Status (KPS) scale (ranging from 0 [dead] to 100 [normal activity, no evidence of disease])	4 weeks