Ulcerative Colitis
Conditions
Keywords
Ulcerative colitis, sacral nerve stimulation
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 exploratory Clinical Trial is to evaluate the safety and efficacy of sacral nerve stimulation in patients with ulcerative colitis.
Interventions
DEVICEG132 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 No maximum
Healthy volunteers
No
Inclusion criteria
* age ≥18 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 at week 12 | 12 weeks | Mayo score at 12 week minus the Mayo score at baseline. The range of Mayo score is 0-12, and higher scores mean worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| interleukin-6 levels at baseline, week 4, 8, 12, 24 and 52 | baseline, 4, 8, 12, 24, and 52 weeks | blood sample |
| interleukin-8 levels at baseline, week 4, 8, 12, 24 and 52 | baseline, 4, 8, 12, 24, and 52 weeks | blood sample |
| interleukin-10 levels at baseline, week 4, 8, 12, 24 and 52 | baseline, 4, 8, 12, 24, and 52 weeks | blood sample |
| interleukin-12P70 levels at baseline, week 4, 8, 12, 24 and 52 | baseline, 4, 8, 12, 24, and 52 weeks | blood sample |
| interleukin-17 levels at baseline, week 4, 8, 12, 24 and 52 | baseline, 4, 8, 12, 24, and 52 weeks | blood sample |
| interleukin-1β levels at baseline, week 4, 8, 12, 24 and 52 | baseline, 4, 8, 12, 24, and 52 weeks | blood sample |
| interleukin-2 levels at baseline, week 4, 8, 12, 24 and 52 | baseline, 4, 8, 12, 24, and 52 weeks | blood sample |
| interleukin-4 levels at baseline, week 4, 8, 12, 24 and 52 | baseline, 4, 8, 12, 24, and 52 weeks | blood sample |
| Change from baseline in the Mayo score at week 24, and 52 | 24 and 52 weeks | Mayo score at 24 week minus the Mayo score at baseline. The range of Mayo score is 0-12, and higher scores mean worse outcome. |
| Clinical remission at Week 12, 24, and 52 | 12, 24, and 52 weeks | overall score ≤2 \[and no individual subscore \>1\] |
| Clinical response at Week 12, 24, and 52 | 12, 24, and 52 weeks | defined as the reduction of baseline scores by ≥3 points |
| Change from baseline in the Truelove and Witts Severity Index at Week 12, 24, and 52 | 12, 24, and 52 weeks | Truelove and Witts Severity Index |
| Endoscopic remission at Week 12, 24, and 52 | 12, 24, and 52 weeks | defined as Mayo endoscopic score ≤ 1 |
| Fecal calprotectin levels at baseline, week 4, 8, 12, 24 and 52 | baseline, 4, 8, 12, 24, and 52 weeks | fecal sample |
| erythrocyte sedimentation rate levels at baseline, week 4, 8, 12, 24 and 52 | baseline, 4, 8, 12, 24, and 52 weeks | blood sample |
| interleukin-5 levels at baseline, week 4, 8, 12, 24 and 52 | baseline, 4, 8, 12, 24, and 52 weeks | blood sample |
| pancreatic polypeptide levels at baseline, week 4, 8, 12, 24 and 52 | baseline, 4, 8, 12, 24, and 52 weeks | blood sample |
| norepinephrine levels at baseline, week 4, 8, 12, 24 and 52 | baseline, 4, 8, 12, 24, and 52 weeks | blood sample |
| Tumor necrosis factor -α levels at baseline, week 4, 8, 12, 24 and 52 | baseline, 4, 8, 12, 24, and 52 weeks | blood sample |
| Interferon-γ levels at baseline, week 4, 8, 12, 24 and 52 | baseline, 4, 8, 12, 24, and 52 weeks | blood sample |
| Interferon-α levels at baseline, week 4, 8, 12, 24 and 52 | baseline, 4, 8, 12, 24, and 52 weeks | blood sample |
| interleukin-10 levels in tissue sample at baseline, week 12, 24 and 52 | baseline, 12, 24, and 52 weeks | Intestinal mucosal tissue sample |
| interleukin-17 levels in tissue sample at baseline, week 12, 24 and 52 | baseline, 12, 24, and 52 weeks | Intestinal mucosal tissue sample |
| Tumor necrosis factor -α levels in tissue sample at baseline, week 12, 24 and 52 | baseline, 12, 24, and 52 weeks | Intestinal mucosal tissue sample |
| acetyl choline levels at baseline, week 12, 24 and 52 | baseline, 12, 24, and 52 weeks | Intestinal mucosal tissue sample |
| Inflammatory Bowel Disease Questionnaire Score at baseline, week 12, 24 and 52 | baseline, 12, 24, and 52 weeks | The range of Inflammatory Bowel Disease Questionnaire Score is 32-224, and higher scores mean worse outcome. |
| Gut metabolites profile at baseline, week 12, 24, and 52 | baseline, 12, 24, and 52 weeks | fecal sample metabolites analysis |
| Gut microbiota profile at baseline, week 12, 24, and 52 | baseline, 12, 24, and 52 weeks | fecal sample microbiota analysis |
| autonomic profile characteristics | baseline, 4, 8, 12, 24, and 36 weeks | heart rate variability indicating sympathetic and parasympathetic activity |
| Hospital Anxiety and Depression scale score | baseline, 12, 24, and 52 weeks | anxious depression. The range of Hospital Anxiety and Depression scale score is 0-21, and higher scores mean worse outcome. |
| Functional magnetic resonance imaging | baseline and 24 weeks | blood oxygen level dependent，BOLD-fMRI |
| C reactive protein levels at baseline, week 4, 8, 12, 24 and 52 | baseline, 4, 8, 12, 24, and 52 weeks | blood sample |
Countries
China
Contacts
Primary ContactJian Wan
Outcome results
None listed