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Clinical Trials in China / NCT03804931
Recruiting Phase 2/3

Fecal Microbiota Transplantation for Ulcerative Colitis

NCT03804931 · tracked via the Priya Life Science China tracker
Sponsor
Guangzhou First People's Hospital
Phase
Phase 2/3
Started
2019-01-20
Last updated
2019-01-15

Condition(s) studied

Ulcerative ColitisFecal Microbiota Transplantation

Investigational drug(s) / intervention(s)

Fecal microbiota transplantationInfusion of Saline5-Aminosalicylic acid(5-ASA) and/or PrednisoneAll Mesalazine trials (5) →All Prednisone trials (173) →

Fecal microbiota transplantation: 200 mL of prepared fecal microbiota suspension from healthy donors' fresh feces was injected into the intestine

Infusion of Saline: Infusion of Saline

5-Aminosalicylic acid(5-ASA) and/or Prednisone: Mesalazine and/or Prednisone

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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)

Primary outcome measure(s)

  • Clinical remission in patient as assessed using Mayo score — 12 weeks
    Total Mayo score less than 2 and no signal item more than 1
  • Clinical improvement in patient as assessed using Mayo score — 12 weeks
    Total Mayo score decreased more than 3

Trial sites (1)

FacilityCityRegionStatus
Guangzhou First People's Hospital Guangzhou Guangdong Recruiting

More Guangzhou First People's Hospital trials in China

Anxiety in Cataract Patients Using Preoperative Music Therapy Active, not recruiting
Fecal Microbiota Transplantation for Irritable Bowel Syndrome Recruiting
Efficacy and Safety of Fecal Microbiota Transplantation Recruiting

Other trials for the same condition

Clinical Safety and Efficacy of Fecal Microbiota Transplantation (FMT) in the Treatment of Alzheimer's Disease Active, not recruiting
A Study of Vedolizumab in Children With Ulcerative Colitis (UC) or Crohn's Disease (CD) Recruiting
A Continuation Study of TAK-279 in Adults With Ulcerative Colitis (UC) and Crohn's Disease (CD) Recruiting
A Study to Evaluate Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderately to Severely Active Ulcerative Colitis (MK-7240-001) Active, not recruiting
Long-term Safety and Efficacy of Sacral Nerve Stimulation in Patients With Ulcerative Colitis Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03804931 on ClinicalTrials.gov ↗ ← All trials in China