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NCT Number: NCT05895981

Exploratory Clinical Trial of 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 exploratory Clinical Trial is to evaluate the 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 and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xijing Hospital

Xi'an, Shaanxi, 710032, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

G132 system, Beijing PINS Medical Co., China

Device

Neuromodulation was performed according to the usual protocol

Primary outcomes

  1. Change from baseline in the Mayo score at week 12

    Time frame: 12 weeks

    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.

Secondary outcomes

  1. Change from baseline in the Mayo score at week 24, and 52

    Time frame: 24 and 52 weeks

    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.

  2. Clinical remission at Week 12, 24, and 52

    Time frame: 12, 24, and 52 weeks

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

  3. Clinical response at Week 12, 24, and 52

    Time frame: 12, 24, and 52 weeks

    defined as the reduction of baseline scores by ≥3 points

  4. Change from baseline in the Truelove and Witts Severity Index at Week 12, 24, and 52

    Time frame: 12, 24, and 52 weeks

    Truelove and Witts Severity Index

  5. Endoscopic remission at Week 12, 24, and 52

    Time frame: 12, 24, and 52 weeks

    defined as Mayo endoscopic score ≤ 1

  6. Fecal calprotectin levels at baseline, week 4, 8, 12, 24 and 52

    Time frame: baseline, 4, 8, 12, 24, and 52 weeks

    fecal sample

  7. erythrocyte sedimentation rate levels at baseline, week 4, 8, 12, 24 and 52

    Time frame: baseline, 4, 8, 12, 24, and 52 weeks

    blood sample

  8. C reactive protein levels at baseline, week 4, 8, 12, 24 and 52

    Time frame: baseline, 4, 8, 12, 24, and 52 weeks

    blood sample

  9. pancreatic polypeptide levels at baseline, week 4, 8, 12, 24 and 52

    Time frame: baseline, 4, 8, 12, 24, and 52 weeks

    blood sample

  10. norepinephrine levels at baseline, week 4, 8, 12, 24 and 52

    Time frame: baseline, 4, 8, 12, 24, and 52 weeks

    blood sample

  11. interleukin-1β levels at baseline, week 4, 8, 12, 24 and 52

    Time frame: baseline, 4, 8, 12, 24, and 52 weeks

    blood sample

  12. interleukin-2 levels at baseline, week 4, 8, 12, 24 and 52

    Time frame: baseline, 4, 8, 12, 24, and 52 weeks

    blood sample

  13. interleukin-4 levels at baseline, week 4, 8, 12, 24 and 52

    Time frame: baseline, 4, 8, 12, 24, and 52 weeks

    blood sample

  14. interleukin-5 levels at baseline, week 4, 8, 12, 24 and 52

    Time frame: baseline, 4, 8, 12, 24, and 52 weeks

    blood sample

  15. interleukin-6 levels at baseline, week 4, 8, 12, 24 and 52

    Time frame: baseline, 4, 8, 12, 24, and 52 weeks

    blood sample

  16. interleukin-8 levels at baseline, week 4, 8, 12, 24 and 52

    Time frame: baseline, 4, 8, 12, 24, and 52 weeks

    blood sample

  17. interleukin-10 levels at baseline, week 4, 8, 12, 24 and 52

    Time frame: baseline, 4, 8, 12, 24, and 52 weeks

    blood sample

  18. interleukin-12P70 levels at baseline, week 4, 8, 12, 24 and 52

    Time frame: baseline, 4, 8, 12, 24, and 52 weeks

    blood sample

  19. interleukin-17 levels at baseline, week 4, 8, 12, 24 and 52

    Time frame: baseline, 4, 8, 12, 24, and 52 weeks

    blood sample

  20. Tumor necrosis factor -α levels at baseline, week 4, 8, 12, 24 and 52

    Time frame: baseline, 4, 8, 12, 24, and 52 weeks

    blood sample

  21. Interferon-γ levels at baseline, week 4, 8, 12, 24 and 52

    Time frame: baseline, 4, 8, 12, 24, and 52 weeks

    blood sample

  22. Interferon-α levels at baseline, week 4, 8, 12, 24 and 52

    Time frame: baseline, 4, 8, 12, 24, and 52 weeks

    blood sample

  23. interleukin-10 levels in tissue sample at baseline, week 12, 24 and 52

    Time frame: baseline, 12, 24, and 52 weeks

    Intestinal mucosal tissue sample

  24. interleukin-17 levels in tissue sample at baseline, week 12, 24 and 52

    Time frame: baseline, 12, 24, and 52 weeks

    Intestinal mucosal tissue sample

  25. Tumor necrosis factor -α levels in tissue sample at baseline, week 12, 24 and 52

    Time frame: baseline, 12, 24, and 52 weeks

    Intestinal mucosal tissue sample

  26. acetyl choline levels at baseline, week 12, 24 and 52

    Time frame: baseline, 12, 24, and 52 weeks

    Intestinal mucosal tissue sample

  27. Inflammatory Bowel Disease Questionnaire Score at baseline, week 12, 24 and 52

    Time frame: baseline, 12, 24, and 52 weeks

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

  28. Gut metabolites profile at baseline, week 12, 24, and 52

    Time frame: baseline, 12, 24, and 52 weeks

    fecal sample metabolites analysis

  29. Gut microbiota profile at baseline, week 12, 24, and 52

    Time frame: baseline, 12, 24, and 52 weeks

    fecal sample microbiota analysis

  30. autonomic profile characteristics

    Time frame: baseline, 4, 8, 12, 24, and 36 weeks

    heart rate variability indicating sympathetic and parasympathetic activity

  31. Hospital Anxiety and Depression scale score

    Time frame: baseline, 12, 24, and 52 weeks

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

  32. Functional magnetic resonance imaging

    Time frame: baseline and 24 weeks

    blood oxygen level dependent，BOLD-fMRI

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Jun 9, 2023
Registry last updated
Dec 4, 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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