Exploratory Clinical Trial of Safety and Efficacy of Sacral Nerve Stimulation in Patients With Ulcerative Colitis.

Study Overview
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Brief Summary
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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.

Official Title
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An Exploratory Clinical Trial to Evaluate the Safety and Efficacy of Sacral Nerve Stimulation in Patients

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Device: G132 system, Beijing PINS Medical Co., China


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sacral nerve stimulation<br> | Device: G132 system, Beijing PINS Medical Co., China<br>* Neuromodulation was performed according to the usual protocol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the Mayo score at week 12 | 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. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the Mayo score at week 24, and 52 | 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. | 24 and 52 weeks | 
| Clinical remission at Week 12, 24, and 52 | overall score ≤2 [and no individual subscore >1] | 12, 24, and 52 weeks | 
| Clinical response at Week 12, 24, and 52 | defined as the reduction of baseline scores by ≥3 points | 12, 24, and 52 weeks | 
| Change from baseline in the Truelove and Witts Severity Index at Week 12, 24, and 52 | Truelove and Witts Severity Index | 12, 24, and 52 weeks | 
| Endoscopic remission at Week 12, 24, and 52 | defined as Mayo endoscopic score ≤ 1 | 12, 24, and 52 weeks | 
| Fecal calprotectin levels at baseline, week 4, 8, 12, 24 and 52 | fecal sample | baseline, 4, 8, 12, 24, and 52 weeks | 
| erythrocyte sedimentation rate levels at baseline, week 4, 8, 12, 24 and 52 | blood sample | baseline, 4, 8, 12, 24, and 52 weeks | 
| C reactive protein levels at baseline, week 4, 8, 12, 24 and 52 | blood sample | baseline, 4, 8, 12, 24, and 52 weeks | 
| pancreatic polypeptide levels at baseline, week 4, 8, 12, 24 and 52 | blood sample | baseline, 4, 8, 12, 24, and 52 weeks | 
| norepinephrine levels at baseline, week 4, 8, 12, 24 and 52 | blood sample | baseline, 4, 8, 12, 24, and 52 weeks | 
| interleukin-1β levels at baseline, week 4, 8, 12, 24 and 52 | blood sample | baseline, 4, 8, 12, 24, and 52 weeks | 
| interleukin-2 levels at baseline, week 4, 8, 12, 24 and 52 | blood sample | baseline, 4, 8, 12, 24, and 52 weeks | 
| interleukin-4 levels at baseline, week 4, 8, 12, 24 and 52 | blood sample | baseline, 4, 8, 12, 24, and 52 weeks | 
| interleukin-5 levels at baseline, week 4, 8, 12, 24 and 52 | blood sample | baseline, 4, 8, 12, 24, and 52 weeks | 
| interleukin-6 levels at baseline, week 4, 8, 12, 24 and 52 | blood sample | baseline, 4, 8, 12, 24, and 52 weeks | 
| interleukin-8 levels at baseline, week 4, 8, 12, 24 and 52 | blood sample | baseline, 4, 8, 12, 24, and 52 weeks | 
| interleukin-10 levels at baseline, week 4, 8, 12, 24 and 52 | blood sample | baseline, 4, 8, 12, 24, and 52 weeks | 
| interleukin-12P70 levels at baseline, week 4, 8, 12, 24 and 52 | blood sample | baseline, 4, 8, 12, 24, and 52 weeks | 
| interleukin-17 levels at baseline, week 4, 8, 12, 24 and 52 | blood sample | baseline, 4, 8, 12, 24, and 52 weeks | 
| Tumor necrosis factor -α levels at baseline, week 4, 8, 12, 24 and 52 | blood sample | baseline, 4, 8, 12, 24, and 52 weeks | 
| Interferon-γ levels at baseline, week 4, 8, 12, 24 and 52 | blood sample | baseline, 4, 8, 12, 24, and 52 weeks | 
| Interferon-α levels at baseline, week 4, 8, 12, 24 and 52 | blood sample | baseline, 4, 8, 12, 24, and 52 weeks | 
| interleukin-10 levels in tissue sample at baseline, week 12, 24 and 52 | Intestinal mucosal tissue sample | baseline, 12, 24, and 52 weeks | 
| interleukin-17 levels in tissue sample at baseline, week 12, 24 and 52 | Intestinal mucosal tissue sample | baseline, 12, 24, and 52 weeks | 
| Tumor necrosis factor -α levels in tissue sample at baseline, week 12, 24 and 52 | Intestinal mucosal tissue sample | baseline, 12, 24, and 52 weeks | 
| acetyl choline levels at baseline, week 12, 24 and 52 | Intestinal mucosal tissue sample | baseline, 12, 24, and 52 weeks | 
| Inflammatory Bowel Disease Questionnaire Score at baseline, week 12, 24 and 52 | The range of Inflammatory Bowel Disease Questionnaire Score is 32-224, and higher scores mean worse outcome. | baseline, 12, 24, and 52 weeks | 
| Gut metabolites profile at baseline, week 12, 24, and 52 | fecal sample metabolites analysis | baseline, 12, 24, and 52 weeks | 
| Gut microbiota profile at baseline, week 12, 24, and 52 | fecal sample microbiota analysis | baseline, 12, 24, and 52 weeks | 
| autonomic profile characteristics | heart rate variability indicating sympathetic and parasympathetic activity | baseline, 4, 8, 12, 24, and 36 weeks | 
| Hospital Anxiety and Depression scale score | anxious depression. The range of Hospital Anxiety and Depression scale score is 0-21, and higher scores mean worse outcome. | baseline, 12, 24, and 52 weeks | 
| Functional magnetic resonance imaging | blood oxygen level dependent，BOLD-fMRI | baseline and 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ulcerative colitis, sacral nerve stimulation