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Fecal Microbiota Transplantation for Ulcerative Colitis

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ClinicalTrials.gov Identifier: NCT03804931
Recruitment Status : Recruiting
First Posted : January 15, 2019
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
Guangzhou First People's Hospital

Tracking Information
First Submitted Date  ICMJE January 6, 2019
First Posted Date  ICMJE January 15, 2019
Last Update Posted Date January 15, 2019
Estimated Study Start Date  ICMJE January 20, 2019
Estimated Primary Completion Date December 31, 2028   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 12, 2019)
  • Clinical remission in patient as assessed using Mayo score [ Time Frame: 12 weeks ]
    Total Mayo score less than 2 and no signal item more than 1
  • Clinical improvement in patient as assessed using Mayo score [ Time Frame: 12 weeks ]
    Total Mayo score decreased more than 3
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 12, 2019)
Intestinal microbiota changing [ Time Frame: 12 weeks ]
The change of intestinal microbiota composition after FMT compared with subject original microbiota and donor's microbiota
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fecal Microbiota Transplantation for Ulcerative Colitis
Official Title  ICMJE Efficacy and Safety of Fecal Microbiota Transplantation for Ulcerative Colitis
Brief Summary Fecal microbiota transplantation (FMT) is a strategy that infuses a fecal suspension containing a healthy donor's microbiota into a patient's gut to restore his/her intestinal microbiome. Fecal microbiota transplantation has been used for several disease,but the efficacy of ulcerative colitis(UC) by fecal microbiota transplantation needs to be further explored.The investigators propose to determine the efficiency and safety of FMT in patients with ulcerative colitis(UC).
Detailed Description The present clinical trial aims to re-establish a gut functionality state of intestinal flora through FMT as a therapy for ulcerative colitis(UC). We established a standard microbiota isolation from donated fresh stool in lab. Then the microbiota is transplanted to the intestine. Patients from Guangzhou First People's Hospital in this study will be assigned to receive FMT at least two times according to associated guidelines and follow-up for at least three months.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Ulcerative Colitis
  • Fecal Microbiota Transplantation
Intervention  ICMJE
  • Procedure: Fecal microbiota transplantation
    200 mL of prepared fecal microbiota suspension from healthy donors' fresh feces was injected into the intestine
  • Procedure: Infusion of Saline
    Infusion of Saline
  • Drug: 5-Aminosalicylic acid(5-ASA) and/or Prednisone
    Mesalazine and/or Prednisone
    Other Names:
    • Mesalazine
    • Prednisone
Study Arms  ICMJE
  • Experimental: Fecal microbiota transplantation
    Fecal microbiota transplantation
    Interventions:
    • Procedure: Fecal microbiota transplantation
    • Drug: 5-Aminosalicylic acid(5-ASA) and/or Prednisone
  • Sham Comparator: placebo fecal microbiota transplantation
    Infusion of Saline
    Interventions:
    • Procedure: Infusion of Saline
    • Drug: 5-Aminosalicylic acid(5-ASA) and/or Prednisone
  • Traditional treatments
    Drug:5-Aminosalicylic acid(5-ASA) and/or Prednisone
    Intervention: Drug: 5-Aminosalicylic acid(5-ASA) and/or Prednisone
Publications * Cui B, Li P, Xu L, Zhao Y, Wang H, Peng Z, Xu H, Xiang J, He Z, Zhang T, Nie Y, Wu K, Fan D, Ji G, Zhang F. Step-up fecal microbiota transplantation strategy: a pilot study for steroid-dependent ulcerative colitis. J Transl Med. 2015 Sep 12;13:298. doi: 10.1186/s12967-015-0646-2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 12, 2019)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2030
Estimated Primary Completion Date December 31, 2028   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Active, moderate to severe severity (Mayo score more than 6)
  • Safety using history of 5-ASA
  • Able to undergo endoscopy examination

Exclusion Criteria:

  • Antibiotic using in 7 days
  • High risk of toxic megacolon
  • Colon cancer or neoplasia in pathophysiology
  • Other severe diseases (eg: cardiovascular, respiratory, gastroenteral and kidney diseases)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Hongli Huang, MM 86-13631316718 honglisums@126.com
Contact: Huiting Chen, MM 86-13926055294 gracy1977@tom.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03804931
Other Study ID Numbers  ICMJE K-2017-103-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Guangzhou First People's Hospital
Study Sponsor  ICMJE Guangzhou First People's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yuqiang Nie, MD Guangzhou First People's Hospital
PRS Account Guangzhou First People's Hospital
Verification Date November 2018

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