Fecal Microbiota Transplantation, Inflammatory Bowel Diseases
Conditions
Brief summary
The study aims to evaluate the clinical efficacy and safety of fecal microbiota transplantation by automatic methods in the treatment of moderate to severe active ulcerative colitis. There are two groups according to FMT pathway ( through a naso-jejunal tube or transendoscopic enteral tubing). Patients were followed up until 2 weeks after the final FMT in hospital.
Interventions
OTHERFMT through a naso-jejunal tube
Prepared feces by automatic methods, then the purified fecal microbiota was delivered into the intestine through a naso-jejunal tube.
OTHERFMT through TET
Prepared feces by automatic methods, then the purified fecal microbiota was delivered into the intestine through a transendoscopic enteral tubing (TET) which is fixed to the cecum with clips under endoscopic guidance.
Sponsors
Air Force Military Medical University, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
\- Eligible patients required a diagnosis of ulcerative colitis made by a primary gastroenterologist based upon history, physical exam, laboratory/radiological studies and gastrointestinal histology. All patients were age ≥ 18 year old at the time of enrollment. They had moderate to severe symptoms with a mayo score between 6\ 12 and an endoscopic subscore ≥2. Patient medication for UC could not have changed for at least one month prior to FMT.
Exclusion criteria
\- Active or history of intraabdominal abscess, acute abdomen or other clinical emergencies requiring emergent management, pregnancy, prior history of FMT, prior history of TNF inhibitors use, or other serious systemic disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| clinical response | 2 weeks after FMT | reduction in the Mayo score of ≥3 points and ≥30% from baseline, with a decrease in the rectal bleeding subscore of ≥1 point or a subscore of ≤1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| clinical remission, safety and progression of disease | 2 weeks after FMT | clinical remission: Mayo score ≤ 2, with no subscore \> 1; progression of disease: measured by initiation of anti-TNFα or colectomy. Adverse event severity and relatedness was graded using NIH criteria. |
Outcome results
None listed