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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

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).

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Fecal Microbiota Transplantation Procedure: Fecal microbiota transplantation Procedure: Infusion of Saline Drug: 5-Aminosalicylic acid(5-ASA) and/or Prednisone Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Fecal Microbiota Transplantation for Ulcerative Colitis
Estimated Study Start Date : January 20, 2019
Estimated Primary Completion Date : December 31, 2028
Estimated Study Completion Date : December 31, 2030

Resource links provided by the National Library of Medicine

Drug Information available for: Prednisone

Arm Intervention/treatment
Experimental: Fecal microbiota transplantation
Fecal microbiota transplantation
Procedure: Fecal microbiota transplantation
200 mL of prepared fecal microbiota suspension from healthy donors' fresh feces was injected into the intestine

Drug: 5-Aminosalicylic acid(5-ASA) and/or Prednisone
Mesalazine and/or Prednisone
Other Names:
  • Mesalazine
  • Prednisone

Sham Comparator: placebo fecal microbiota transplantation
Infusion of Saline
Procedure: Infusion of Saline
Infusion of Saline

Drug: 5-Aminosalicylic acid(5-ASA) and/or Prednisone
Mesalazine and/or Prednisone
Other Names:
  • Mesalazine
  • Prednisone

Traditional treatments
Drug:5-Aminosalicylic acid(5-ASA) and/or Prednisone
Drug: 5-Aminosalicylic acid(5-ASA) and/or Prednisone
Mesalazine and/or Prednisone
Other Names:
  • Mesalazine
  • Prednisone




Primary Outcome Measures :
  1. 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

  2. Clinical improvement in patient as assessed using Mayo score [ Time Frame: 12 weeks ]
    Total Mayo score decreased more than 3


Secondary Outcome Measures :
  1. Intestinal microbiota changing [ Time Frame: 12 weeks ]
    The change of intestinal microbiota composition after FMT compared with subject original microbiota and donor's microbiota



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

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): NCT03804931


Contacts
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Contact: Hongli Huang, MM 86-13631316718 honglisums@126.com
Contact: Huiting Chen, MM 86-13926055294 gracy1977@tom.com

Locations
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China, Guangdong
Guangzhou First People's Hospital Recruiting
Guangzhou, Guangdong, China
Contact: Hongli Huang, MM    86-13631316718    honglisums@126.com   
Contact: Huiting chen, MM    86-13926055294    gracy1977@tom.com   
Sub-Investigator: Haoming Xu, MM         
Sponsors and Collaborators
Guangzhou First People's Hospital
Investigators
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Principal Investigator: Yuqiang Nie, MD Guangzhou First People's Hospital

Publications:
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Responsible Party: Guangzhou First People's Hospital
ClinicalTrials.gov Identifier: NCT03804931     History of Changes
Other Study ID Numbers: K-2017-103-01
First Posted: January 15, 2019    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Pathologic Processes
Aminosalicylic Acid
Prednisone
Mesalamine
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antirheumatic Agents
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents