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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

February 9, 2013
February 13, 2013
January 9, 2018
November 2012
December 2022   (Final data collection date for primary outcome measure)
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)
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)
Complete list of historical versions of study NCT01790061 on ClinicalTrials.gov Archive Site
Adverse events [ Time Frame: Ten years ]
Number and severity of adverse events
  • 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.
Not Provided
Not Provided
 
Standardized Fecal Microbiota Transplantation for Ulcerative Colitis
Efficacy, Durability and Safety of Standardized Fecal Microbiota Transplantation in Patients With Moderate to Severe Ulcerative Colitis
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).
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.
Interventional
Phase 2
Phase 3
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Bacteria
  • Microbiota
  • Fecal Microbiota Transplantation
  • Inflammatory Bowel Disease
  • Ulcerative Colitis
  • 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
  • Drug: Traditional treatments
    Medications
    Other Name: Traditional treatments according to associated guidelines
  • Experimental: Standardized FMT
    endoscopy Tubing Once or repeat
    Intervention: Procedure: Standardized FMT
  • Experimental: Traditional treatments
    Oral Tubing
    Intervention: Drug: Traditional treatments

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
60
December 2032
December 2022   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
6 Years to 80 Years   (Child, Adult, Older Adult)
No
Contact: Faming Zhang, MD,PhD 086-25-58509883 fzhang@njmu.edu.cn
Contact: Faming Zhang, MD,PhD
China
 
 
NCT01790061
FMT-CN-121123
Yes
Not Provided
Not Provided
Faming Zhang, The Second Hospital of Nanjing Medical University
The Second Hospital of Nanjing Medical University
Fourth Military Medical University
Study Chair: Huijie Zhang, MD,PhD The Second Afiliated Hospital of Nanjing Medical University
The Second Hospital of Nanjing Medical University
January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP