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Standardized Fecal Microbiota Transplantation for Crohn's Diseases

NCT ID: NCT01793831

Last Updated: 2024-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2025-12-31

Brief Summary

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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

Detailed Description

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The present clinical trial aims to re-establish a gut functionality state of intestinal flora through FMT as a therapy for CD (all age range,HBI\>4). We established a standard microbiota isolation from donated fresh stool in lab. The microbiota is then transplanted into the intestine via endoscopy or other established methods, such as mid-gut or colonic transendoscopic enteral tubing. Patients from multi-clinical centers in this study will be assigned to receive FMT or traditional treatments according to associated guidelines and follow-up for at least one year. Blood tests, imaging, endoscopy and questionnaire will be used to assess participants at study start and at study completion.

Conditions

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Inflammatory Bowel Disease Crohn's Disease (CD)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fecal microbiota transplantation

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

Group Type EXPERIMENTAL

FMT

Intervention Type PROCEDURE

Standard FMT

Traditional treatments

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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FMT

Standard FMT

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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).

Exclusion Criteria

Presence of serious conditions that made them unsuitable for inclusion (e.g., malignant neoplasms, cardiopulmonary failure, serious liver or kidney disease).
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

UNKNOWN

Sponsor Role collaborator

The First Affiliated Hospital of Air Force Medicial University

OTHER

Sponsor Role collaborator

The Second Hospital of Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Faming Zhang

Associate professor, Gastroenterology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Huai'an, Jiangsu, China

Site Status RECRUITING

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

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Faming Zhang, MD, PhD

Role: CONTACT

[email protected]
86-025-58509883

Huijie Zhang, MD, PhD

Role: CONTACT

[email protected]
86-025-58509670

Facility Contacts

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Honggang Wang, MD

Role: primary

[email protected]
86-18851268720

Faming Zhang, MD, PhD

Role: primary

[email protected]
86-025-58509883

Faming Zhang

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 23034604 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23041678 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24222969 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29179485 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28684845 (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)

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.

Reference Type DERIVED
PMID: 40890737 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39109266 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34079458 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33064186 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31958884 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30357440 (View on PubMed)

Other Identifiers

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FMC-CN-121101

Identifier Type: -

Identifier Source: org_study_id