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

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

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 Overview

• Status: Recruiting
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Device: G132 system, Beijing PINS Medical Co., China

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jian Wan; Phone Number: +8615529202305; Email: 408127528@qq.com

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Recruiting
      • Xijing Hospital
      • Contact: Jian Wan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Xijing Hospital
• Investigators: Study Chair: Kaichun Wu, PhD, Air Force Military Medical University, China

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2023
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: May 15, 2023
• First Submitted That Met QC Criteria: June 8, 2023
• First Posted (Actual): June 9, 2023

Study Record Updates

• Last Update Posted (Estimated): December 4, 2025
• Last Update Submitted That Met QC Criteria: November 26, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Ulcerative colitis; sacral nerve stimulation
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: KY20232100

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No