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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Neuromodulation was performed according to the usual protocol
Xijing Hospital
Xi'an, Shaanxi, China
RECRUITINGChange 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.
Time frame: 12 weeks
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.
Time frame: 24 and 52 weeks
Clinical remission at Week 12, 24, and 52
overall score ≤2 \[and no individual subscore \>1\]
Time frame: 12, 24, and 52 weeks
Clinical response at Week 12, 24, and 52
defined as the reduction of baseline scores by ≥3 points
Time frame: 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
Time frame: 12, 24, and 52 weeks
Endoscopic remission at Week 12, 24, and 52
defined as Mayo endoscopic score ≤ 1
Time frame: 12, 24, and 52 weeks
Fecal calprotectin levels at baseline, week 4, 8, 12, 24 and 52
fecal sample
Time frame: baseline, 4, 8, 12, 24, and 52 weeks
erythrocyte sedimentation rate levels at baseline, week 4, 8, 12, 24 and 52
blood sample
Time frame: baseline, 4, 8, 12, 24, and 52 weeks
C reactive protein levels at baseline, week 4, 8, 12, 24 and 52
blood sample
Time frame: baseline, 4, 8, 12, 24, and 52 weeks
pancreatic polypeptide levels at baseline, week 4, 8, 12, 24 and 52
blood sample
Time frame: baseline, 4, 8, 12, 24, and 52 weeks
norepinephrine levels at baseline, week 4, 8, 12, 24 and 52
blood sample
Time frame: baseline, 4, 8, 12, 24, and 52 weeks
interleukin-1β levels at baseline, week 4, 8, 12, 24 and 52
blood sample
Time frame: baseline, 4, 8, 12, 24, and 52 weeks
interleukin-2 levels at baseline, week 4, 8, 12, 24 and 52
blood sample
Time frame: baseline, 4, 8, 12, 24, and 52 weeks
interleukin-4 levels at baseline, week 4, 8, 12, 24 and 52
blood sample
Time frame: baseline, 4, 8, 12, 24, and 52 weeks
interleukin-5 levels at baseline, week 4, 8, 12, 24 and 52
blood sample
Time frame: baseline, 4, 8, 12, 24, and 52 weeks
interleukin-6 levels at baseline, week 4, 8, 12, 24 and 52
blood sample
Time frame: baseline, 4, 8, 12, 24, and 52 weeks
interleukin-8 levels at baseline, week 4, 8, 12, 24 and 52
blood sample
Time frame: baseline, 4, 8, 12, 24, and 52 weeks
interleukin-10 levels at baseline, week 4, 8, 12, 24 and 52
blood sample
Time frame: baseline, 4, 8, 12, 24, and 52 weeks
interleukin-12P70 levels at baseline, week 4, 8, 12, 24 and 52
blood sample
Time frame: baseline, 4, 8, 12, 24, and 52 weeks
interleukin-17 levels at baseline, week 4, 8, 12, 24 and 52
blood sample
Time frame: baseline, 4, 8, 12, 24, and 52 weeks
Tumor necrosis factor -α levels at baseline, week 4, 8, 12, 24 and 52
blood sample
Time frame: baseline, 4, 8, 12, 24, and 52 weeks
Interferon-γ levels at baseline, week 4, 8, 12, 24 and 52
blood sample
Time frame: baseline, 4, 8, 12, 24, and 52 weeks
Interferon-α levels at baseline, week 4, 8, 12, 24 and 52
blood sample
Time frame: 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
Time frame: baseline, 12, 24, and 52 weeks
interleukin-17 levels in tissue sample at baseline, week 12, 24 and 52
Intestinal mucosal tissue sample
Time frame: 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
Time frame: baseline, 12, 24, and 52 weeks
acetyl choline levels at baseline, week 12, 24 and 52
Intestinal mucosal tissue sample
Time frame: 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.
Time frame: baseline, 12, 24, and 52 weeks
Gut metabolites profile at baseline, week 12, 24, and 52
fecal sample metabolites analysis
Time frame: baseline, 12, 24, and 52 weeks
Gut microbiota profile at baseline, week 12, 24, and 52
fecal sample microbiota analysis
Time frame: baseline, 12, 24, and 52 weeks
autonomic profile characteristics
heart rate variability indicating sympathetic and parasympathetic activity
Time frame: 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.
Time frame: baseline, 12, 24, and 52 weeks
Functional magnetic resonance imaging
blood oxygen level dependent，BOLD-fMRI
Time frame: baseline and 24 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.