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

• Sponsor: Xijing Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05895981
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 20
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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 exploratory Clinical Trial is to evaluate the safety and efficacy of sacral nerve stimulation in patients with ulcerative colitis.

Condition or Disease	Intervention/Treatment	Phase
Ulcerative Colitis	Device: G132 system, Beijing PINS Medical Co., China	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Exploratory Clinical Trial to Evaluate the Safety and Efficacy of Sacral Nerve Stimulation in Patients
• Anticipated Study Start Date: Jul 1, 2023
• Anticipated Primary Completion Date: Jan 1, 2025
• Anticipated Study Completion Date: Mar 1, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

1. Change from baseline in the Mayo score at week 24, and 52 [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 [12, 24, and 52 weeks]

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

3. Clinical response at Week 12, 24, and 52 [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 [12, 24, and 52 weeks]

   Truelove and Witts Severity Index

5. Endoscopic remission at Week 12, 24, and 52 [12, 24, and 52 weeks]

   defined as Mayo endoscopic score ≤ 1

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

   fecal sample

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

   blood sample

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

   blood sample

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

   blood sample

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

    blood sample

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

    blood sample

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

    blood sample

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

    blood sample

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

    blood sample

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

    blood sample

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

    blood sample

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

    blood sample

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

    blood sample

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

    blood sample

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

    blood sample

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

    blood sample

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

    Intestinal mucosal tissue sample

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

    Intestinal mucosal tissue sample

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

    Intestinal mucosal tissue sample

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

    fecal sample metabolites analysis

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

    fecal sample microbiota analysis

30. autonomic profile characteristics [baseline, 4, 8, 12, 24, and 36 weeks]

    heart rate variability indicating sympathetic and parasympathetic activity

31. Hospital Anxiety and Depression scale score [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 [baseline and 24 weeks]

    blood oxygen level dependent，BOLD-fMRI

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Xijing Hospital	Xi'an	Shaanxi	China	710032

Sponsors and Collaborators

• Xijing Hospital

Investigators

• Study Chair: Kaichun Wu, PhD, Air Force Military Medical University, China

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Xijing Hospital
• ClinicalTrials.gov Identifier: NCT05895981
• Other Study ID Numbers: KY20232100
• First Posted: Jun 9, 2023
• Last Update Posted: Jun 9, 2023
• Last Verified: Apr 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Xijing Hospital: Ulcerative colitis; sacral nerve stimulation
• Additional relevant MeSH terms: Colitis; Colitis, Ulcerative; Ulcer

Study Results

No Results Posted as of Jun 9, 2023