Fecal Microbiota Transplantation for Ulcerative Colitis
Recruiting · NCT03804931 · Interventional (participants receive a specific treatment) · Lead sponsor: Guangzhou First People's Hospital
View the official record on ClinicalTrials.gov →Interventions studied
5-Aminosalicylic acid(5-ASA) and/or PrednisoneFecal microbiota transplantationInfusion of Saline
What this trial is about
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).
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2, Phase 3
Study type
Interventional (participants receive a specific treatment)
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)
Where it is running
1 location listed.
- Guangzhou First People's Hospital - Guangzhou, Guangdong, China