Exploratory Clinical Trial of Safety and Efficacy of Sacral Nerve Stimulation in Patients With Ulcerative Colitis.
- Conditions
- Ulcerative Colitis
- Interventions
- Device: G132 system, Beijing PINS Medical Co., China
- Registration Number
- NCT05895981
- Lead Sponsor
- Xijing Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 15
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Sacral nerve stimulation G132 system, Beijing PINS Medical Co., China -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Clinical remission at Week 12, 24, and 52 12, 24, and 52 weeks overall score ≤2 \[and no individual subscore \>1\]
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.
Fecal calprotectin levels at baseline, week 4, 8, 12, 24 and 52 baseline, 4, 8, 12, 24, and 52 weeks fecal 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
interleukin-5 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
Tumor necrosis factor -α levels at baseline, week 4, 8, 12, 24 and 52 baseline, 4, 8, 12, 24, and 52 weeks blood sample
C reactive protein 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
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
erythrocyte sedimentation rate 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
interleukin-10 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
Clinical response at Week 12, 24, and 52 12, 24, and 52 weeks defined as the reduction of baseline scores by ≥3 points
interleukin-8 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
acetyl choline levels at baseline, week 12, 24 and 52 baseline, 12, 24, and 52 weeks Intestinal mucosal tissue sample
interleukin-6 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
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
Functional magnetic resonance imaging baseline and 24 weeks blood oxygen level dependent，BOLD-fMRI
Gut microbiota profile at baseline, week 12, 24, and 52 baseline, 12, 24, and 52 weeks fecal sample microbiota analysis
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
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
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.
autonomic profile characteristics baseline, 4, 8, 12, 24, and 36 weeks heart rate variability indicating sympathetic and parasympathetic activity
Trial Locations
- Locations (1)
Xijing Hospital
🇨🇳Xi'an, Shaanxi, China