Standardized Fecal Microbiota Transplantation for Ulcerative Colitis

NCT01790061 | Recruiting Phase 2 DMC

• 1 other identifier: FMT-CN-121123
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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 FMT for Ulcerative Colitis (UC), Crohn's diseases, irritable bowel syndrome (IBS) and constipation have also met with some success. This is an initial step into investigating the potential efficacy of standardized fecal bacteriotherapy through mid-gut (at least below duodenal papilla) for UC, the investigators propose to determine the efficiency and safety of FMT in a series of 500 patients with moderate to severe UC (Montreal classification).

Conditions

Bacteria; Microbiota; Fecal Microbiota Transplantation; Inflammatory Bowel Disease; Ulcerative Colitis

Keywords

Gut bacteria; Gut flora; Bacteriotherapy; Fecal Microbiota Transplantation; Inflammatory bowel disease; Ulcerative colitis

Outcome Measures

Primary Outcomes (1)

• Efficacy of FMT

  The efficacy and durability of clinical remission (days) after Fecal Microbiota Transplantation procedure.Defined as Montreal score S0 (clinical remission)

  On year

Secondary Outcomes (5)

• Adverse events

  Ten years

• sleep quality evaluated by the Pittsburgh Sleep Quality Index (PSQI)

  before FMT, 1 month and 12 weeks after FMT

• sleep quality evaluated by the Insomnia Severity Index (ISI)

  before FMT, 1 month and 12 weeks after FMT

• anxiety and depression evaluated by the Hospital Anxiety and Depression Scale (HADS)

  before FMT, 1 month and 12 weeks after FMT

• fatigue evaluated by the Functional Assessment of Chronic Illness Therapy fatigue subscale (FACIT-F)

  before FMT, 1 month and 12 weeks after FMT

Study Arms (2)

Standardized FMT

EXPERIMENTAL

endoscopy Tubing Once or repeat

Procedure: Standardized FMT

Traditional treatments

EXPERIMENTAL

Oral Tubing

Drug: Traditional treatments

Interventions

Standardized FMT PROCEDURE

Fecal microbiota transplantation by gastroscopy administration of fresh or frozen bacteria from healthy donor to the mid-gut or whole colon

Also known as: Fecal Microbiota Transplantation, Fecal Microbiota Therapy, fecal transplantation

Standardized FMT

Traditional treatments DRUG

Medications

Also known as: Traditional treatments according to associated guidelines

Traditional treatments

Eligibility Criteria

• Age: 6 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who had been diagnosed with UC through a combination of typical clinical symptoms, endoscopy, and histological criteria for at least 3 months, and patients who failed to achieve satisfactory efficacy for UC from the previous therapies.

You may not qualify if:

• Patients were excluded if accompanied by other severe diseases, including other intestinal diseases (e.g., Clostridioides difficile infection), malignant neoplasm, cardiopulmonary failure, and serious liver and kidney disease, refused to complete the follow-up, and underwent FMT or WMT before.

Sponsors & Collaborators

• The Second Hospital of Nanjing Medical University: lead
• Air Force Military Medical University, China: collaborator

Study Sites (1)

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

Nanjing, Jiangsu, 210011, China

RECRUITING

Related Publications (12)

• 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.

  PMID: 22183182 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 F, Luo W, Shi Y, Fan Z, Ji G. Should we standardize the 1,700-year-old fecal microbiota transplantation? Am J Gastroenterol. 2012 Nov;107(11):1755; author reply p.1755-6. doi: 10.1038/ajg.2012.251. No abstract available.

  PMID: 23160295 BACKGROUND

• Bennet JD, Brinkman M. Treatment of ulcerative colitis by implantation of normal colonic flora. Lancet. 1989 Jan 21;1(8630):164. doi: 10.1016/s0140-6736(89)91183-5. No abstract available.

  PMID: 2563083 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

• Zhang S, Lu G, Wang W, Li Q, Wang R, Zhang Z, Wu X, Liang C, Liu Y, Li P, Wen Q, Cui B, Zhang F. A predictive machine-learning model for clinical decision-making in washed microbiota transplantation on ulcerative colitis. Comput Struct Biotechnol J. 2024 Aug 24;24:583-592. doi: 10.1016/j.csbj.2024.08.021. eCollection 2024 Dec.

  PMID: 39281978 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

• 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

• Li Q, Ding X, Liu K, Marcella C, Liu X, Zhang T, Liu Y, Li P, Xiang L, Cui B, Wang J, Bai J, Zhang F. Fecal Microbiota Transplantation for Ulcerative Colitis: The Optimum Timing and Gut Microbiota as Predictors for Long-Term Clinical Outcomes. Clin Transl Gastroenterol. 2020 Aug;11(8):e00224. doi: 10.14309/ctg.0000000000000224.

  PMID: 32955197 DERIVED

• Li Q, Zhang T, Ding X, Xiang L, Cui B, Buch H, Zhang F. Enhancing patient adherence to fecal microbiota transplantation maintains the long-term clinical effects in ulcerative colitis. Eur J Gastroenterol Hepatol. 2020 Aug;32(8):955-962. doi: 10.1097/MEG.0000000000001725.

  PMID: 32282545 DERIVED

• Ding X, Li Q, Li P, Zhang T, Cui B, Ji G, Lu X, Zhang F. Long-Term Safety and Efficacy of Fecal Microbiota Transplant in Active Ulcerative Colitis. Drug Saf. 2019 Jul;42(7):869-880. doi: 10.1007/s40264-019-00809-2.

  PMID: 30972640 DERIVED

• Cui B, Li P, Xu L, Zhao Y, Wang H, Peng Z, Xu H, Xiang J, He Z, Zhang T, Nie Y, Wu K, Fan D, Ji G, Zhang F. Step-up fecal microbiota transplantation strategy: a pilot study for steroid-dependent ulcerative colitis. J Transl Med. 2015 Sep 12;13:298. doi: 10.1186/s12967-015-0646-2.

  PMID: 26363929 DERIVED

Related Links

• Fecal microbiota transplantation

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Huijie Zhang, MD,PhD

  The Second Afiliated Hospital of Nanjing Medical University

  STUDY CHAIR

Central Study Contacts

Faming Zhang, MD,PhD

CONTACT

086-25-58509883; fzhang@njmu.edu.cn

Faming Zhang, MD,PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• 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 9, 2013
• First Posted: February 13, 2013
• Study Start: February 1, 2013
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 19, 2024

Record last verified: 2024-04

Locations

CN (1)