Inflammatory Bowel Disease,Ulcerative Colitis
Conditions
Interventions
Test group:TET catheter: Following Transendoscopic Enteral Tubing (TET) placement, perfuse Roseburia suspension (dissolved in 20 mL sterile normal saline) via the catheter daily for 14 consecutive day
Sponsors
The 925th Hospital of Chinese People's Liberation Army Joint Logistic Support Force
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18–75 years; 2. Confirmed diagnosis of ulcerative colitis (UC) for no less than 3 months; 3. Mild to moderate active stage: modified Mayo score of 4–10 points (endoscopic score >= 1); 4. Inadequate response or intolerance to conventional treatment, or refusal of step-up therapy.
Exclusion criteria
Exclusion criteria: 1. Crohn’s disease and infectious enteritis; 2. Recent use of antibiotics or probiotics within less than 2 weeks; 3. Severe hepatic and renal insufficiency, malignant tumors, pregnancy or lactation; 4. Toxic megacolon and intestinal obstruction.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical response (a reduction in total Mayo score of >=3 points and >=30%);Endoscopic improvement (>=1-point reduction in the Mayo endoscopic subscore); | — |
Secondary
| Measure | Time frame |
|---|---|
| Fecal Calprotectin;C-reactive protein;fecal metagenome; | — |
Countries
China
Contacts
Public ContactWei Fu
The 925th Hospital of the Joint Logistic Support Force
Outcome results
None listed