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NCT Number: NCT07114159

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

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

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sacral nerve stimulation

Device

Device: G132 system, Beijing PINS Medical Co., China Neuromodulation was performed according to the usual protocol

Primary outcomes

  1. Change from baseline in the Mayo score

    Time frame: From baseline to 8 years

    The range of Mayo score is 0-12, and higher scores mean worse outcome

Secondary outcomes

  1. Clinical remission

    Time frame: From baseline to 8 years

    overall mayo score ≤2 [and no individual subscore >1]

  2. Clinical response

    Time frame: From baseline to 8 years

    defined as the reduction of baseline scores by ≥3 points

  3. Change from baseline in the Truelove and Witts Severity Index

    Time frame: From baseline to 8 years

    Truelove and Witts Severity Index

  4. Endoscopic remission

    Time frame: From baseline to 8 years

    defined as Mayo endoscopic score ≤ 1

  5. Fecal calprotectin levels

    Time frame: From baseline to 8 years

    fecal sample

  6. erythrocyte sedimentation rate levels

    Time frame: From baseline to 8 years

    blood sample

  7. C reactive protein levels

    Time frame: From baseline to 8 years

    blood sample

  8. Inflammatory Bowel Disease Questionnaire Score

    Time frame: From baseline to 8 years

    The range of Inflammatory Bowel Disease Questionnaire Score is 32-224, and higher scores mean worse outcome

  9. Hospital Anxiety and Depression scale score

    Time frame: From baseline to 8 years

    The range of Hospital Anxiety and Depression scale score is 0-21, and higher scores mean worse outcome

  10. Gut microbiota profile

    Time frame: From baseline to 8 years

    fecal sample

  11. The Pittsburgh Sleep Quality Index

    Time frame: From baseline to 8 years

    higher scores mean worse outcome

Study contacts

Contact information is provided by the study sponsor or research team.

Jian Wan

CONTACT

[email protected]

15529202305

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Registry information

Official study title

An Open-label Clinical Trial to Evaluate the Long-term Safety and Efficacy of Sacral Nerve Stimulation in Patients With Ulcerative Colitis

Important dates

Study start
2025
Primary completion
2032
Study completion
2032
First posted
Aug 11, 2025
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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