Fecal Microbiota Transplantation, Ulcerative Colitis
Conditions
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.
Interventions
PROCEDUREFecal microbiota transplantation
200 mL of prepared fecal microbiota suspension from healthy donors' fresh feces was injected into the intestine
PROCEDUREInfusion of Saline
Infusion of Saline
DRUG5-Aminosalicylic acid(5-ASA) and/or Prednisone
Mesalazine and/or Prednisone
Sponsors
Guangzhou First People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intestinal microbiota changing | 12 weeks | The change of intestinal microbiota composition after FMT compared with subject original microbiota and donor's microbiota |
Countries
China
Contacts
Primary ContactHongli Huang, MM
Backup ContactHuiting Chen, MM
Outcome results
None listed