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

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05895981
• Other study ID #: KY20232100
• Status: Recruiting
• Phase: N/A
• Start date: July 20, 2023
• Est. completion date: March 1, 2025

Study information

• Verified date: April 2024
• Source: Xijing Hospital
• Contact: Jian Wan
• Phone: +8615529202305
• Email: 408127528[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: March 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

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

Locations

Country	Name	City	State
China	Xijing Hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in the Mayo score at week 12	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.	12 weeks
Secondary	Change from baseline in the Mayo score at week 24, and 52	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.	24 and 52 weeks
Secondary	Clinical remission at Week 12, 24, and 52	overall score =2 [and no individual subscore >1]	12, 24, and 52 weeks
Secondary	Clinical response at Week 12, 24, and 52	defined as the reduction of baseline scores by =3 points	12, 24, and 52 weeks
Secondary	Change from baseline in the Truelove and Witts Severity Index at Week 12, 24, and 52	Truelove and Witts Severity Index	12, 24, and 52 weeks
Secondary	Endoscopic remission at Week 12, 24, and 52	defined as Mayo endoscopic score = 1	12, 24, and 52 weeks
Secondary	Fecal calprotectin levels at baseline, week 4, 8, 12, 24 and 52	fecal sample	baseline, 4, 8, 12, 24, and 52 weeks
Secondary	erythrocyte sedimentation rate levels at baseline, week 4, 8, 12, 24 and 52	blood sample	baseline, 4, 8, 12, 24, and 52 weeks
Secondary	C reactive protein levels at baseline, week 4, 8, 12, 24 and 52	blood sample	baseline, 4, 8, 12, 24, and 52 weeks
Secondary	pancreatic polypeptide levels at baseline, week 4, 8, 12, 24 and 52	blood sample	baseline, 4, 8, 12, 24, and 52 weeks
Secondary	norepinephrine levels at baseline, week 4, 8, 12, 24 and 52	blood sample	baseline, 4, 8, 12, 24, and 52 weeks
Secondary	interleukin-1ß levels at baseline, week 4, 8, 12, 24 and 52	blood sample	baseline, 4, 8, 12, 24, and 52 weeks
Secondary	interleukin-2 levels at baseline, week 4, 8, 12, 24 and 52	blood sample	baseline, 4, 8, 12, 24, and 52 weeks
Secondary	interleukin-4 levels at baseline, week 4, 8, 12, 24 and 52	blood sample	baseline, 4, 8, 12, 24, and 52 weeks
Secondary	interleukin-5 levels at baseline, week 4, 8, 12, 24 and 52	blood sample	baseline, 4, 8, 12, 24, and 52 weeks
Secondary	interleukin-6 levels at baseline, week 4, 8, 12, 24 and 52	blood sample	baseline, 4, 8, 12, 24, and 52 weeks
Secondary	interleukin-8 levels at baseline, week 4, 8, 12, 24 and 52	blood sample	baseline, 4, 8, 12, 24, and 52 weeks
Secondary	interleukin-10 levels at baseline, week 4, 8, 12, 24 and 52	blood sample	baseline, 4, 8, 12, 24, and 52 weeks
Secondary	interleukin-12P70 levels at baseline, week 4, 8, 12, 24 and 52	blood sample	baseline, 4, 8, 12, 24, and 52 weeks
Secondary	interleukin-17 levels at baseline, week 4, 8, 12, 24 and 52	blood sample	baseline, 4, 8, 12, 24, and 52 weeks
Secondary	Tumor necrosis factor -a levels at baseline, week 4, 8, 12, 24 and 52	blood sample	baseline, 4, 8, 12, 24, and 52 weeks
Secondary	Interferon-? levels at baseline, week 4, 8, 12, 24 and 52	blood sample	baseline, 4, 8, 12, 24, and 52 weeks
Secondary	Interferon-a levels at baseline, week 4, 8, 12, 24 and 52	blood sample	baseline, 4, 8, 12, 24, and 52 weeks
Secondary	interleukin-10 levels in tissue sample at baseline, week 12, 24 and 52	Intestinal mucosal tissue sample	baseline, 12, 24, and 52 weeks
Secondary	interleukin-17 levels in tissue sample at baseline, week 12, 24 and 52	Intestinal mucosal tissue sample	baseline, 12, 24, and 52 weeks
Secondary	Tumor necrosis factor -a levels in tissue sample at baseline, week 12, 24 and 52	Intestinal mucosal tissue sample	baseline, 12, 24, and 52 weeks
Secondary	acetyl choline levels at baseline, week 12, 24 and 52	Intestinal mucosal tissue sample	baseline, 12, 24, and 52 weeks
Secondary	Inflammatory Bowel Disease Questionnaire Score at baseline, week 12, 24 and 52	The range of Inflammatory Bowel Disease Questionnaire Score is 32-224, and higher scores mean worse outcome.	baseline, 12, 24, and 52 weeks
Secondary	Gut metabolites profile at baseline, week 12, 24, and 52	fecal sample metabolites analysis	baseline, 12, 24, and 52 weeks
Secondary	Gut microbiota profile at baseline, week 12, 24, and 52	fecal sample microbiota analysis	baseline, 12, 24, and 52 weeks
Secondary	autonomic profile characteristics	heart rate variability indicating sympathetic and parasympathetic activity	baseline, 4, 8, 12, 24, and 36 weeks
Secondary	Hospital Anxiety and Depression scale score	anxious depression. The range of Hospital Anxiety and Depression scale score is 0-21, and higher scores mean worse outcome.	baseline, 12, 24, and 52 weeks
Secondary	Functional magnetic resonance imaging	blood oxygen level dependent,BOLD-fMRI	baseline and 24 weeks