Ulcerative Colitis
Conditions
Brief summary
Although the incidence of inflammatory bowel disease is stable in North American and European countries, the incidence of inflammatory bowel disease is increasing in newly industrialized countries, especially in China. The treatment drugs for ulcerative colitis include 5-aminosalicylic acid (5-ASA), glucocorticoids, immunosuppressants, and biological agents. The aim of this clinical trial is to evaluate the long-term safety and efficacy of sacral nerve stimulation in patients with ulcerative colitis
Interventions
DEVICESacral nerve stimulation
Device: G132 system, Beijing PINS Medical Co., China Neuromodulation was performed according to the usual protocol
Sponsors
Xijing Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* age 18-65 years * ulcerative colitis diagnosed for at least 3 mouths. * Mayo score 6-12, Mayo endoscopic score 2-3 points * resistant to medical treatment
Exclusion criteria
* Treatment-naive ulcerative colitis (no previous treatment) * Acute severe ulcerative colitis * Currently taking any biologicals * Previous surgical treatment or severe colitis at imminent risk of surgery * infective colitis * Other systemic diseases * Pregnancy and lactation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in the Mayo score | From baseline to 8 years | The range of Mayo score is 0-12, and higher scores mean worse outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical response | From baseline to 8 years | defined as the reduction of baseline scores by ≥3 points |
| Change from baseline in the Truelove and Witts Severity Index | From baseline to 8 years | Truelove and Witts Severity Index |
| Endoscopic remission | From baseline to 8 years | defined as Mayo endoscopic score ≤ 1 |
| Fecal calprotectin levels | From baseline to 8 years | fecal sample |
| erythrocyte sedimentation rate levels | From baseline to 8 years | blood sample |
| Clinical remission | From baseline to 8 years | overall mayo score ≤2 \[and no individual subscore \>1\] |
| Inflammatory Bowel Disease Questionnaire Score | From baseline to 8 years | The range of Inflammatory Bowel Disease Questionnaire Score is 32-224, and higher scores mean worse outcome |
| Hospital Anxiety and Depression scale score | From baseline to 8 years | The range of Hospital Anxiety and Depression scale score is 0-21, and higher scores mean worse outcome |
| Gut microbiota profile | From baseline to 8 years | fecal sample |
| The Pittsburgh Sleep Quality Index | From baseline to 8 years | higher scores mean worse outcome |
| C reactive protein levels | From baseline to 8 years | blood sample |
Countries
China
Contacts
Primary ContactJian Wan
Outcome results
None listed