Trial record 14 of 425 for:    "ulcerative colitis"

Standardized Fecal Microbiota Transplantation for Ulcerative Colitis

This study is currently recruiting participants.
Verified December 2013 by The Second Hospital of Nanjing Medical University
Sponsor:
Information provided by (Responsible Party):
Faming Zhang, The Second Hospital of Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT01790061
First received: February 9, 2013
Last updated: December 15, 2013
Last verified: December 2013
  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
Flora
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
Endpoint Classification: Safety/Efficacy Study
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 The Second Hospital of Nanjing Medical University:

Primary Outcome Measures:
  • durability of clinical remission [ Time Frame: One month ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Number of patients with worsened disease. Increase in Montreal score S1, S2 and S3.

  • Adverse events [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    Number of adverse events.


Estimated Enrollment: 60
Study Start Date: November 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (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
Other Name: 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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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   
Sponsors and Collaborators
The Second Hospital of Nanjing Medical University
  More Information

Additional Information:
Publications:
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
Study First Received: February 9, 2013
Last Updated: December 15, 2013
Health Authority: China: Ministry of Health

Keywords provided by 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
Colitis, Ulcerative
Inflammatory Bowel Diseases
Intestinal Diseases
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 16, 2014