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Standardized Fecal Microbiota Transplantation for Ulcerative Colitis

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ClinicalTrials.gov Identifier: NCT01790061
Recruitment Status : Recruiting
First Posted : February 13, 2013
Last Update Posted : January 9, 2018
Sponsor:
Collaborator:
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.

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

U.S. FDA Resources

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
Medications
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



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

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 ClinicalTrials.gov identifier (NCT number): NCT01790061


Contacts
Contact: Faming Zhang, MD,PhD 086-25-58509883 fzhang@njmu.edu.cn
Contact: Faming Zhang, MD,PhD

Locations
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    fzhang@njmu.edu.cn   
Sponsors and Collaborators
The Second Hospital of Nanjing Medical University
Fourth Military Medical University
Investigators
Study Chair: Huijie Zhang, MD,PhD The Second Afiliated Hospital of Nanjing Medical University

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Faming Zhang, Associate professor, Gastroenterology, The Second Hospital of Nanjing Medical University
ClinicalTrials.gov Identifier: NCT01790061     History of Changes
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
Bacteriotherapy
Fecal Microbiota Transplantation
Inflammatory bowel disease
Ulcerative colitis

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Intestinal Diseases
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Pathologic Processes