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Standardized Fecal Microbiota Transplantation for Ulcerative Colitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01790061
Recruitment Status : Recruiting
First Posted : February 13, 2013
Last Update Posted : January 9, 2018
Fourth Military Medical University
Information provided by (Responsible Party):
Faming Zhang, The Second Hospital of Nanjing Medical University

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).

Condition or disease Intervention/treatment Phase
Bacteria Microbiota Fecal Microbiota Transplantation Inflammatory Bowel Disease Ulcerative Colitis Procedure: Standardized FMT Drug: Traditional treatments Phase 2 Phase 3

Detailed Description:
The present clinical trial aims to re-establish a gut functionality state of intestinal microbiota 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(s) or traditional treatments according to associated guidelines and follow-up for long term. All data were recorded in China Microbiota Transplantation System.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy, Durability and Safety of Standardized Fecal Microbiota Transplantation in Patients With Moderate to Severe Ulcerative Colitis
Study Start Date : November 2012
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2032

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Standardized FMT
endoscopy Tubing Once or repeat
Procedure: Standardized FMT
Fecal microbiota transplantation by gastroscopy administration of fresh or frozen bacteria from healthy donor to the mid-gut or whole colon
Other Names:
  • Fecal Microbiota Transplantation
  • Fecal Microbiota Therapy
  • fecal transplantation

Experimental: Traditional treatments
Oral Tubing
Drug: Traditional treatments
Other Name: Traditional treatments according to associated guidelines

Primary Outcome Measures :
  1. Efficacy of FMT [ Time Frame: On year ]
    The efficacy and durability of clinical remission (days) after Fecal Microbiota Transplantation procedure.Defined as Montreal score S0 (clinical remission)

Secondary Outcome Measures :
  1. Adverse events [ Time Frame: Ten years ]
    Number and severity of adverse events

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Moderate to serious UC (Montreal classification)

Exclusion Criteria:

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

With contraindication of endoscopy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01790061

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

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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   
Sponsors and Collaborators
The Second Hospital of Nanjing Medical University
Fourth Military Medical University
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Study Chair: Huijie Zhang, MD,PhD The Second Afiliated Hospital of Nanjing Medical University

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Faming Zhang, Associate professor, Gastroenterology, The Second Hospital of Nanjing Medical University Identifier: NCT01790061    
Other Study ID Numbers: FMT-CN-121123
First Posted: February 13, 2013    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018
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:
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Colitis, Ulcerative
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Pathologic Processes