Recruiting

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.

Recruiting

Interested in participating?

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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

Location contact

Jian Wan

CONTACT

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

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

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.
Clinical remission at Week 12, 24, and 52

Time frame: 12, 24, and 52 weeks

overall score ≤2 [and no individual subscore >1]
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
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
Endoscopic remission at Week 12, 24, and 52

Time frame: 12, 24, and 52 weeks

defined as Mayo endoscopic score ≤ 1
Fecal calprotectin levels at baseline, week 4, 8, 12, 24 and 52

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

fecal sample
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
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
pancreatic polypeptide levels at baseline, week 4, 8, 12, 24 and 52

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

blood sample
norepinephrine levels at baseline, week 4, 8, 12, 24 and 52

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

blood sample
interleukin-1β levels at baseline, week 4, 8, 12, 24 and 52

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

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

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

blood sample
interleukin-4 levels at baseline, week 4, 8, 12, 24 and 52

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

blood sample
interleukin-5 levels at baseline, week 4, 8, 12, 24 and 52

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

blood sample
interleukin-6 levels at baseline, week 4, 8, 12, 24 and 52

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

blood sample
interleukin-8 levels at baseline, week 4, 8, 12, 24 and 52

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

blood sample
interleukin-10 levels at baseline, week 4, 8, 12, 24 and 52

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

blood sample
interleukin-12P70 levels at baseline, week 4, 8, 12, 24 and 52

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

blood sample
interleukin-17 levels at baseline, week 4, 8, 12, 24 and 52

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

blood sample
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
Interferon-γ levels at baseline, week 4, 8, 12, 24 and 52

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

blood sample
Interferon-α levels at baseline, week 4, 8, 12, 24 and 52

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

blood sample
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
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
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
acetyl choline levels at baseline, week 12, 24 and 52

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

Intestinal mucosal tissue sample
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.
Gut metabolites profile at baseline, week 12, 24, and 52

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

fecal sample metabolites analysis
Gut microbiota profile at baseline, week 12, 24, and 52

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

fecal sample microbiota analysis
autonomic profile characteristics

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

heart rate variability indicating sympathetic and parasympathetic activity
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.
Functional magnetic resonance imaging

Time frame: baseline and 24 weeks

blood oxygen level dependent，BOLD-fMRI

Study contacts

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

Jian Wan

CONTACT

[email protected]

+8615529202305

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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Key information

Conditions

Age range

Sex eligibility

Study type

Phase

Primary location

Xijing Hospital

Location contact

Who can participate

Treatment and study plan

G132 system, Beijing PINS Medical Co., China

Primary outcomes

Change from baseline in the Mayo score at week 12

Secondary outcomes

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

Clinical remission at Week 12, 24, and 52

Clinical response at Week 12, 24, and 52

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

Endoscopic remission at Week 12, 24, and 52

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

autonomic profile characteristics

Hospital Anxiety and Depression scale score

Functional magnetic resonance imaging

Study contacts

Sponsors and collaborators

Lead sponsor

Registry information

Official study title

Important dates

Related clinical trials

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A Study to Evaluate Efficacy and Safety of MK-8690 in Participants With Moderately to Severely Active Ulcerative Colitis (MK-8690-002)

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of RO7837195 in Participants With Moderately to Severely Active Ulcerative Colitis (UC)

A Study of Long-acting Antibodies Alone and in Combinations for Moderate to Severe Ulcerative Colitis