We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
ClinicalTrials.gov Identifier:
NCT01790061
First Posted: February 13, 2013
Last Update Posted: January 23, 2015
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. Read our disclaimer for details.
Collaborator:
Fourth Military Medical University
Information provided by (Responsible Party):
Faming Zhang, The Second Hospital of Nanjing Medical University
  Purpose
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
Bacteria Microbiota 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: 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

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
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

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   
China, Shaanxi
Xijing Hospital of Digestive Diseases Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Mi Tian       xjyyxh@fmmu.edu.cn   
Principal Investigator: Kaichun Wu         
Sponsors and Collaborators
The Second Hospital of Nanjing Medical University
Fourth Military Medical University
  More Information

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 Submitted: February 9, 2013
First Posted: February 13, 2013
Last Update Posted: January 23, 2015
Last Verified: November 2014

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


To Top