Ulcerative ColitisNCT05895981
Exploratory Clinical Trial of Safety and Efficacy of Sacral Nerve Stimulation in Patients With Ulcerative Colitis.
A study testing G132 system, Beijing PINS Medical Co., China in people with Ulcerative Colitis, run by Xijing Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- G132 system, Beijing PINS Medical Co., China
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2023to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xijing Hospital
Xi'an, Shaanxi, 710032
Jian Wan
About this study
Official title: An Exploratory Clinical Trial to Evaluate the Safety and Efficacy of Sacral Nerve Stimulation in Patients
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.
- Conditions
- Ulcerative Colitis
- Being tested
- G132 system, Beijing PINS Medical Co., China
- Keywords
- Ulcerative colitis, sacral nerve stimulation
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G132 system, Beijing PINS Medical Co., ChinaDevice
Neuromodulation was performed according to the usual protocol
| Study group | Role | What they receive |
|---|---|---|
| Sacral nerve stimulation | Experimental | Not described Receives: Device: G132 system, Beijing PINS Medical Co., China |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (32)
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.
Measured: 24 and 52 weeks
Clinical remission at Week 12, 24, and 52
overall score ≤2 [and no individual subscore >1]
Measured: 12, 24, and 52 weeks
Clinical response at Week 12, 24, and 52
defined as the reduction of baseline scores by ≥3 points
Measured: 12, 24, and 52 weeks
Change from baseline in the Truelove and Witts Severity Index at Week 12, 24, and 52
Truelove and Witts Severity Index
Measured: 12, 24, and 52 weeks
Endoscopic remission at Week 12, 24, and 52
defined as Mayo endoscopic score ≤ 1
Measured: 12, 24, and 52 weeks
Fecal calprotectin levels at baseline, week 4, 8, 12, 24 and 52
fecal sample
Measured: baseline, 4, 8, 12, 24, and 52 weeks
erythrocyte sedimentation rate levels at baseline, week 4, 8, 12, 24 and 52
blood sample
Measured: baseline, 4, 8, 12, 24, and 52 weeks
C reactive protein levels at baseline, week 4, 8, 12, 24 and 52
blood sample
Measured: baseline, 4, 8, 12, 24, and 52 weeks
pancreatic polypeptide levels at baseline, week 4, 8, 12, 24 and 52
blood sample
Measured: baseline, 4, 8, 12, 24, and 52 weeks
norepinephrine levels at baseline, week 4, 8, 12, 24 and 52
blood sample
Measured: baseline, 4, 8, 12, 24, and 52 weeks
interleukin-1β levels at baseline, week 4, 8, 12, 24 and 52
blood sample
Measured: baseline, 4, 8, 12, 24, and 52 weeks
interleukin-2 levels at baseline, week 4, 8, 12, 24 and 52
blood sample
Measured: baseline, 4, 8, 12, 24, and 52 weeks
interleukin-4 levels at baseline, week 4, 8, 12, 24 and 52
blood sample
Measured: baseline, 4, 8, 12, 24, and 52 weeks
interleukin-5 levels at baseline, week 4, 8, 12, 24 and 52
blood sample
Measured: baseline, 4, 8, 12, 24, and 52 weeks
interleukin-6 levels at baseline, week 4, 8, 12, 24 and 52
blood sample
Measured: baseline, 4, 8, 12, 24, and 52 weeks
interleukin-8 levels at baseline, week 4, 8, 12, 24 and 52
blood sample
Measured: baseline, 4, 8, 12, 24, and 52 weeks
interleukin-10 levels at baseline, week 4, 8, 12, 24 and 52
blood sample
Measured: baseline, 4, 8, 12, 24, and 52 weeks
interleukin-12P70 levels at baseline, week 4, 8, 12, 24 and 52
blood sample
Measured: baseline, 4, 8, 12, 24, and 52 weeks
interleukin-17 levels at baseline, week 4, 8, 12, 24 and 52
blood sample
Measured: baseline, 4, 8, 12, 24, and 52 weeks
Tumor necrosis factor -α levels at baseline, week 4, 8, 12, 24 and 52
blood sample
Measured: baseline, 4, 8, 12, 24, and 52 weeks
Interferon-γ levels at baseline, week 4, 8, 12, 24 and 52
blood sample
Measured: baseline, 4, 8, 12, 24, and 52 weeks
Interferon-α levels at baseline, week 4, 8, 12, 24 and 52
blood sample
Measured: baseline, 4, 8, 12, 24, and 52 weeks
interleukin-10 levels in tissue sample at baseline, week 12, 24 and 52
Intestinal mucosal tissue sample
Measured: baseline, 12, 24, and 52 weeks
interleukin-17 levels in tissue sample at baseline, week 12, 24 and 52
Intestinal mucosal tissue sample
Measured: baseline, 12, 24, and 52 weeks
Tumor necrosis factor -α levels in tissue sample at baseline, week 12, 24 and 52
Intestinal mucosal tissue sample
Measured: baseline, 12, 24, and 52 weeks
acetyl choline levels at baseline, week 12, 24 and 52
Intestinal mucosal tissue sample
Measured: baseline, 12, 24, and 52 weeks
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.
Measured: baseline, 12, 24, and 52 weeks
Gut metabolites profile at baseline, week 12, 24, and 52
fecal sample metabolites analysis
Measured: baseline, 12, 24, and 52 weeks
Gut microbiota profile at baseline, week 12, 24, and 52
fecal sample microbiota analysis
Measured: baseline, 12, 24, and 52 weeks
autonomic profile characteristics
heart rate variability indicating sympathetic and parasympathetic activity
Measured: baseline, 4, 8, 12, 24, and 36 weeks
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.
Measured: baseline, 12, 24, and 52 weeks
Functional magnetic resonance imaging
blood oxygen level dependent，BOLD-fMRI
Measured: baseline and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start20 Jul 2023
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kaichun Wu, PhD, Study chair, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05895981
- Sponsor's protocol ID
- KY20232100
- Status last verified
- Apr 2025
- First submitted
- 15 May 2023
- Last updated
- 4 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Trial to Evaluate the Safety and Efficacy of Sacral Nerve Stimulation in Patients
- ClinicalTrials.gov ID
- NCT05895981
- Acronym / sponsor ID
- KY20232100
- Conditions
- Ulcerative Colitis
- Keywords
- Ulcerative colitis, sacral nerve stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 20 Jul 2023 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 9 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sacral nerve stimulation | Experimental | Device: G132 system, Beijing PINS Medical Co., China |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| G132 system, Beijing PINS Medical Co., ChinaNeuromodulation was performed according to the usual protocol | Device | Sacral nerve stimulation |
Primary outcome
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.
32 secondary outcomes
Change from baseline in the Mayo score at week 24, and 52
Time frame: 24 and 52 weeks
Clinical remission at Week 12, 24, and 52
Time frame: 12, 24, and 52 weeks
Clinical response at Week 12, 24, and 52
Time frame: 12, 24, and 52 weeks
Change from baseline in the Truelove and Witts Severity Index at Week 12, 24, and 52
Time frame: 12, 24, and 52 weeks
Endoscopic remission at Week 12, 24, and 52
Time frame: 12, 24, and 52 weeks
Fecal calprotectin levels at baseline, week 4, 8, 12, 24 and 52
Time frame: baseline, 4, 8, 12, 24, and 52 weeks
erythrocyte sedimentation rate levels at baseline, week 4, 8, 12, 24 and 52
Time frame: baseline, 4, 8, 12, 24, and 52 weeks
C reactive protein levels at baseline, week 4, 8, 12, 24 and 52
Time frame: baseline, 4, 8, 12, 24, and 52 weeks
pancreatic polypeptide levels at baseline, week 4, 8, 12, 24 and 52
Time frame: baseline, 4, 8, 12, 24, and 52 weeks
norepinephrine levels at baseline, week 4, 8, 12, 24 and 52
Time frame: baseline, 4, 8, 12, 24, and 52 weeks
interleukin-1β levels at baseline, week 4, 8, 12, 24 and 52
Time frame: baseline, 4, 8, 12, 24, and 52 weeks
interleukin-2 levels at baseline, week 4, 8, 12, 24 and 52
Time frame: baseline, 4, 8, 12, 24, and 52 weeks
interleukin-4 levels at baseline, week 4, 8, 12, 24 and 52
Time frame: baseline, 4, 8, 12, 24, and 52 weeks
interleukin-5 levels at baseline, week 4, 8, 12, 24 and 52
Time frame: baseline, 4, 8, 12, 24, and 52 weeks
interleukin-6 levels at baseline, week 4, 8, 12, 24 and 52
Time frame: baseline, 4, 8, 12, 24, and 52 weeks
interleukin-8 levels at baseline, week 4, 8, 12, 24 and 52
Time frame: baseline, 4, 8, 12, 24, and 52 weeks
interleukin-10 levels at baseline, week 4, 8, 12, 24 and 52
Time frame: baseline, 4, 8, 12, 24, and 52 weeks
interleukin-12P70 levels at baseline, week 4, 8, 12, 24 and 52
Time frame: baseline, 4, 8, 12, 24, and 52 weeks
interleukin-17 levels at baseline, week 4, 8, 12, 24 and 52
Time frame: baseline, 4, 8, 12, 24, and 52 weeks
Tumor necrosis factor -α levels at baseline, week 4, 8, 12, 24 and 52
Time frame: baseline, 4, 8, 12, 24, and 52 weeks
Interferon-γ levels at baseline, week 4, 8, 12, 24 and 52
Time frame: baseline, 4, 8, 12, 24, and 52 weeks
Interferon-α levels at baseline, week 4, 8, 12, 24 and 52
Time frame: baseline, 4, 8, 12, 24, and 52 weeks
interleukin-10 levels in tissue sample at baseline, week 12, 24 and 52
Time frame: baseline, 12, 24, and 52 weeks
interleukin-17 levels in tissue sample at baseline, week 12, 24 and 52
Time frame: baseline, 12, 24, and 52 weeks
Tumor necrosis factor -α levels in tissue sample at baseline, week 12, 24 and 52
Time frame: baseline, 12, 24, and 52 weeks
acetyl choline levels at baseline, week 12, 24 and 52
Time frame: baseline, 12, 24, and 52 weeks
Inflammatory Bowel Disease Questionnaire Score at baseline, week 12, 24 and 52
Time frame: baseline, 12, 24, and 52 weeks
Gut metabolites profile at baseline, week 12, 24, and 52
Time frame: baseline, 12, 24, and 52 weeks
Gut microbiota profile at baseline, week 12, 24, and 52
Time frame: baseline, 12, 24, and 52 weeks
autonomic profile characteristics
Time frame: baseline, 4, 8, 12, 24, and 36 weeks
Hospital Anxiety and Depression scale score
Time frame: baseline, 12, 24, and 52 weeks
Functional magnetic resonance imaging
Time frame: baseline and 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kaichun Wu, PhD study chair
Air Force Military Medical University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing G132 system, Beijing PINS Medical Co., China in people with Ulcerative Colitis, run by Xijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jian Wan (+8615529202305, 408127528@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the Mayo score at week 12 (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.