Long-term sacral nerve stimulation for people with ulcerative colitis
Official title: An Open-label Clinical Trial to Evaluate the Long-term Safety and Efficacy of Sacral Nerve Stimulation in Patients With Ulcerative Colitis
Run by Xijing Hospital · NCT07114159 · Data updated 2026-11-12
This will test whether long-term sacral nerve stimulation helps adults aged 18–65 with treatment-resistant moderate-to-severe ulcerative colitis.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 15 (estimated) |
| Sponsor | Xijing Hospital Academic / other |
| Locations | 1 site (Xi'an, Shaanxi) |
| Status | Recruiting |
| Started | August 2, 2025 |
| Main results expected | December 1, 2032 |
| Study ends | December 1, 2032 |
| Registry record updated | August 11, 2025 |
| Trial ID | NCT07114159 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–65 with ulcerative colitis for at least 3 months, Mayo score 6–12 and endoscopic score 2–3, who are resistant to medical treatment and not currently taking biological therapies are ideal candidates.
✕Probably not a fit
Patients who are treatment-naive, have acute severe colitis, active infective colitis, are on biologic therapy, have had prior relevant surgery or are at imminent risk of surgery, have other systemic diseases, or are pregnant/lactating are unlikely to benefit or are ineligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults with moderate-to-severe ulcerative colitis who have not responded to standard medical therapy will receive sacral nerve stimulation and be followed long-term for safety and clinical response. Key inclusion criteria include age 18–65, disease duration of at least 3 months, a Mayo score of 6–12 and an endoscopic score of 2–3, while major exclusions include acute severe colitis, current biologic therapy, recent surgery or imminent surgical need, infective colitis, other systemic diseases, and pregnancy or lactation. Outcomes will include changes in clinical disease activity, endoscopic findings, and monitoring of adverse events over extended follow-up. All procedures and follow-up visits are conducted at Xijing Hospital in Xi'an, Shaanxi, China.
Why it matters
Potential benefit: If successful, sacral nerve stimulation could reduce symptoms and mucosal inflammation and lower reliance on systemic drugs or surgery.
How similar studies have gone: Neuromodulation approaches such as sacral nerve stimulation are experimental for ulcerative colitis, with only small case series and early reports showing mixed and preliminary results.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Xijing Hospital
Xi'an, Shaanxi, China Recruiting
Study contacts
- Study coordinator: Jian Wan
- Email: 408127528@qq.com
- Phone: 15529202305
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.