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Standardized Fecal Microbiota Transplantation for Ulcerative Colitis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2014 by Faming Zhang, The Second Hospital of Nanjing Medical University.
Recruitment status was:  Recruiting
Fourth Military Medical University
Information provided by (Responsible Party):
Faming Zhang, The Second Hospital of Nanjing Medical University Identifier:
First received: February 9, 2013
Last updated: November 21, 2014
Last verified: November 2014
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 60 patients with moderate to severe UC (Montreal classification).

Condition Intervention Phase
Fecal Microbiota Transplantation
Inflammatory Bowel Disease
Ulcerative Colitis
Procedure: Standardized Fecal Microbiota Transplantation
Drug: Traditional treatments according to associated guidelines
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy, Durability and Safety of Standardized Fecal Microbiota Transplantation in Patients With Moderate to Severe Ulcerative Colitis

Resource links provided by NLM:

Further study details as provided by Faming Zhang, The Second Hospital of Nanjing Medical University:

Primary Outcome Measures:
  • durability of clinical remission [ Time Frame: One month ]
    The durability of clinical remission (days) after Fecal Microbiota Transplantation procedure.Defined as Montreal score S0 (clinical remission)

Secondary Outcome Measures:
  • Patients with worsened disease [ Time Frame: one year ]
    Number of patients with worsened disease. Increase in Montreal score S1, S2 and S3.

  • Adverse events [ Time Frame: one year ]
    Number of adverse events.

Estimated Enrollment: 60
Study Start Date: November 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Standardized Fecal Microbiota Transplantation
Standardized Fecal Microbiota Transplantation, once.
Procedure: Standardized Fecal Microbiota Transplantation
Fecal microbiota transplantation by gastroscopy administration of fresh or frozen bacteria from healthy donor to the mid-gut (below the second part of duodenum).
Other Names:
  • Fecal Microbiota Transplantation
  • Fecal Microbiota Therapy
  • fecal transplantation
Sham Comparator: Traditional treatments
Traditional treatments according to associated guidelines
Drug: Traditional treatments according to associated guidelines
Traditional treatments according to associated guidelines

Detailed Description:
The present clinical trial aims to re-establish a gut functionality state of intestinal flora through FMT as a therapy for UC. Investigators established a standard bacteria isolation from donated fresh stool in lab. Then the bacteria is transplanted to mid-gut through regular gastroscope. Patients in this study will assigned to receive FMT only once or traditional treatments according to associated guidelines and follow-up for at least one year. Blood tests , endoscopy and questionnaire will be used to assess participants at study start and at study completion.

Ages Eligible for Study:   10 Years to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Mild to moderate UC (Montreal classification)

Exclusion Criteria:

Diagnosed as UC first time. No history of using Biologic,immunomodulatory therapy or corticosteroid therapy.

With contraindication of endoscopy.

  Contacts and Locations
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Please refer to this study by its identifier: NCT01790061

Contact: Faming Zhang, MD,PhD 086-25-58509883

China, Jiangsu
Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University Recruiting
Nanjing, Jiangsu, China, 210011
Contact: Faming Zhang, MD, PhD    086-25-58509883   
China, Shaanxi
Xijing Hospital of Digestive Diseases Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Mi Tian   
Principal Investigator: Kaichun Wu         
Sponsors and Collaborators
The Second Hospital of Nanjing Medical University
Fourth Military Medical University
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Faming Zhang, Associate professor, Gastroenterology, The Second Hospital of Nanjing Medical University Identifier: NCT01790061     History of Changes
Other Study ID Numbers: FMT-CN-121123
Study First Received: February 9, 2013
Last Updated: November 21, 2014

Keywords provided by Faming Zhang, The Second Hospital of Nanjing Medical University:
Gut bacteria
Gut flora
Fecal Microbiota Transplantation
Inflammatory bowel disease
Ulcerative colitis

Additional relevant MeSH terms:
Colitis, Ulcerative
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Pathologic Processes processed this record on May 25, 2017