Standardized Fecal Microbiota Transplantation for Crohn's Diseases

NCT01793831 | Recruiting DMC

• 1 other identifier: FMC-CN-121101
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 2

Brief Summary

The gut microbiota is considered to constitute a "microbial organ" which has pivotal roles in the intestinal diseases and body's metabolism. Evidence from animal and human studies strongly supports the link between intestinal bacteria and inflammatory bowel diseases (IBD). Dozens of studies reported its efficacy in treatment of severe Clostridium difficile colitis. Preliminary studies using fecal microbiota transplantation (FMT) for Ulcerative Colitis (UC), Crohn's diseases (CD), irritable bowel syndrome (IBS) and constipation have also met with some success. However, the results on CD is very limited. This marks the initial step in exploring the potential efficacy of fecal bacteriotherapy for CD. The investigators aim to evaluate the effectiveness, durability, and safety of FMT in a cohort of at least 500 patients with CD over a ten-year period

Conditions

Inflammatory Bowel Disease; Crohn's Disease (CD)

Keywords

Inflammatory bowel disease; Fecal transplantation; Fecal bacteriotherapy; Fecal microbiota transplantation; Crohn's disease

Outcome Measures

Primary Outcomes (1)

• Clinical remission

  Clinical remission defined as HBI score ≦ 4. For patients with complications such as intestinal obstruction, Clinical remission can be defined as obstruction improvement. The endpoint of follow-up is the time of clinical recurrence.

  Up to one year

Secondary Outcomes (6)

• Costs

  Up to one year

• Adverse events

  During FMT and ten years after FMT

• Sleep quality

  before FMT, 1 month after FMT, 12 weeks after FMT

• Fatigue

  before FMT, 1 month after FMT, 12 weeks after FMT

• Anxiety and depression

  before FMT, 1 month after FMT, 12 weeks after FMT

Study Arms (2)

Fecal microbiota transplantation

EXPERIMENTAL

Standard fecal microbiota transplantation, which has been defined as washed microbiota transplantation since 2019.

Procedure: FMT

Traditional treatments

NO INTERVENTION

Traditional treatments for Crohn's disease and its complications according to the guidelines.

Interventions

FMT PROCEDURE

Standard FMT

Fecal microbiota transplantation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of Crohn's disease, with the diagnosis remaining unchanged after at least three months of follow-up.
• Willingness to undergo FMT (Fecal Microbiota Transplantation).

Sponsors & Collaborators

• The Second Hospital of Nanjing Medical University: lead
• The Affiliated Huaian NO.1 People's Hospital of Nanjing Medical University: collaborator
• The First Affiliated Hospital of Air Force Medicial University: collaborator

Study Sites (2)

The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University

Huai'an, Jiangsu, 223000, China

RECRUITING

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

Nanjing, Jiangsu, 210011, China

RECRUITING

Related Publications (12)

• Damman CJ, Miller SI, Surawicz CM, Zisman TL. The microbiome and inflammatory bowel disease: is there a therapeutic role for fecal microbiota transplantation? Am J Gastroenterol. 2012 Oct;107(10):1452-9. doi: 10.1038/ajg.2012.93.

  PMID: 23034604 BACKGROUND

• Aroniadis OC, Brandt LJ. Fecal microbiota transplantation: past, present and future. Curr Opin Gastroenterol. 2013 Jan;29(1):79-84. doi: 10.1097/MOG.0b013e32835a4b3e.

  PMID: 23041678 BACKGROUND

• Zhang FM, Wang HG, Wang M, Cui BT, Fan ZN, Ji GZ. Fecal microbiota transplantation for severe enterocolonic fistulizing Crohn's disease. World J Gastroenterol. 2013 Nov 7;19(41):7213-6. doi: 10.3748/wjg.v19.i41.7213.

  PMID: 24222969 BACKGROUND

• Zhang T, Xiang J, Cui B, He Z, Li P, Chen H, Xu L, Ji G, Nie Y, Wu K, Fan D, Huang G, Bai J, Zhang F. Cost-effectiveness analysis of fecal microbiota transplantation for inflammatory bowel disease. Oncotarget. 2017 Oct 4;8(51):88894-88903. doi: 10.18632/oncotarget.21491. eCollection 2017 Oct 24.

  PMID: 29179485 BACKGROUND

• He Z, Li P, Zhu J, Cui B, Xu L, Xiang J, Zhang T, Long C, Huang G, Ji G, Nie Y, Wu K, Fan D, Zhang F. Multiple fresh fecal microbiota transplants induces and maintains clinical remission in Crohn's disease complicated with inflammatory mass. Sci Rep. 2017 Jul 6;7(1):4753. doi: 10.1038/s41598-017-04984-z.

  PMID: 28684845 BACKGROUND

• 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: 25168749 BACKGROUND

• Lu G, Zhang S, Wang R, Wu X, Chen Y, Wen Q, Cui B, Zhang F, Li P. Fecal microbiota transplantation improves bile acid malabsorption in patients with inflammatory bowel disease: results of microbiota and metabolites from two cohort studies. BMC Med. 2025 Sep 1;23(1):511. doi: 10.1186/s12916-025-04353-y.

  PMID: 40890737 DERIVED

• Li Q, Liu Y, Zhang Z, Zhang S, Ding X, Zhang F. Washed Microbiota Transplantation Improves the Sleep Quality in Patients with Inflammatory Bowel Disease. Nat Sci Sleep. 2024 Aug 2;16:1141-1152. doi: 10.2147/NSS.S460882. eCollection 2024.

  PMID: 39109266 DERIVED

• Li Q, Ding X, Liu Y, Marcella C, Dai M, Zhang T, Bai J, Xiang L, Wen Q, Cui B, Zhang F. Fecal Microbiota Transplantation is a Promising Switch Therapy for Patients with Prior Failure of Infliximab in Crohn's Disease. Front Pharmacol. 2021 May 17;12:658087. doi: 10.3389/fphar.2021.658087. eCollection 2021.

  PMID: 34079458 DERIVED

• Zhang T, Li P, Wu X, Lu G, Marcella C, Ji X, Ji G, Zhang F. Alterations of Akkermansia muciniphila in the inflammatory bowel disease patients with washed microbiota transplantation. Appl Microbiol Biotechnol. 2020 Dec;104(23):10203-10215. doi: 10.1007/s00253-020-10948-7. Epub 2020 Oct 16.

  PMID: 33064186 DERIVED

• Xiang L, Ding X, Li Q, Wu X, Dai M, Long C, He Z, Cui B, Zhang F. Efficacy of faecal microbiota transplantation in Crohn's disease: a new target treatment? Microb Biotechnol. 2020 May;13(3):760-769. doi: 10.1111/1751-7915.13536. Epub 2020 Jan 20.

  PMID: 31958884 DERIVED

• Li P, Zhang T, Xiao Y, Tian L, Cui B, Ji G, Liu YY, Zhang F. Timing for the second fecal microbiota transplantation to maintain the long-term benefit from the first treatment for Crohn's disease. Appl Microbiol Biotechnol. 2019 Jan;103(1):349-360. doi: 10.1007/s00253-018-9447-x. Epub 2018 Oct 24.

  PMID: 30357440 DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Central Study Contacts

Faming Zhang, MD, PhD

CONTACT

86-025-58509883; fzhang@njmu.edu.cn

Huijie Zhang, MD, PhD

CONTACT

86-025-58509670; zhjssm@163.com

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: Associate professor, Gastroenterology

Study Record Dates

• First Submitted: February 13, 2013
• First Posted: February 18, 2013
• Study Start: February 1, 2013
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 29, 2024

Record last verified: 2024-08

Locations

CN (2)