Long-term Safety and Efficacy of Sacral Nerve Stimulation in Patients With Ulcerative Colitis

Not Applicable

Recruiting

• Conditions: Ulcerative Colitis

• Registration Number: NCT07114159
• 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 clinical trial is to evaluate the long-term safety and efficacy of sacral nerve stimulation in patients with ulcerative colitis

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study Start: 2025-08-02
• Study First Submitted: 2025-08-04
• Study First Submitted QC: 2025-08-04
• Last Update Submitted: 2025-08-04
• Study First Posted: 2025-08-11
• Last Update Posted: 2025-08-11
• Primary Completion: 2032-12-01
• Study Completion: 2032-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change from baseline in the Mayo score	From baseline to 8 years	The range of Mayo score is 0-12, and higher scores mean worse outcome

Secondary Outcome Measures

Name	Time	Method
Clinical remission	From baseline to 8 years	overall mayo score ≤2 \[and no individual subscore \>1\]
Clinical response	From baseline to 8 years	defined as the reduction of baseline scores by ≥3 points
Change from baseline in the Truelove and Witts Severity Index	From baseline to 8 years	Truelove and Witts Severity Index
Endoscopic remission	From baseline to 8 years	defined as Mayo endoscopic score ≤ 1
Fecal calprotectin levels	From baseline to 8 years	fecal sample
erythrocyte sedimentation rate levels	From baseline to 8 years	blood sample
C reactive protein levels	From baseline to 8 years	blood sample
Inflammatory Bowel Disease Questionnaire Score	From baseline to 8 years	The range of Inflammatory Bowel Disease Questionnaire Score is 32-224, and higher scores mean worse outcome
Hospital Anxiety and Depression scale score	From baseline to 8 years	The range of Hospital Anxiety and Depression scale score is 0-21, and higher scores mean worse outcome
Gut microbiota profile	From baseline to 8 years	fecal sample
The Pittsburgh Sleep Quality Index	From baseline to 8 years	higher scores mean worse outcome

Trial Locations

Locations (1)

Xijing Hospital; 🇨🇳 Xi'an, Shaanxi, China