Ulcerative ColitisNCT07114159
Long-term Safety and Efficacy of Sacral Nerve Stimulation in Patients With Ulcerative Colitis
A study testing Sacral nerve stimulation 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 to 65 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Sacral nerve stimulation
- 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
- 2 Aug 2025to 1 Dec 2032
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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, +8615529202305, 408127528@qq.com
About this study
Official title: An Open-label Clinical Trial to Evaluate the Long-term 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 clinical trial is to evaluate the long-term safety and efficacy of sacral nerve stimulation in patients with ulcerative colitis
- Conditions
- Ulcerative Colitis
- Being tested
- 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.
Sacral nerve stimulationDevice
Device: G132 system, Beijing PINS Medical Co., China Neuromodulation was performed according to the usual protocol
| Study group | Role | What they receive |
|---|---|---|
| Sacral nerve stimulation | Experimental | Not described Receives: Device: Sacral nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the Mayo score
The range of Mayo score is 0-12, and higher scores mean worse outcome
Measured: From baseline to 8 years
Secondary outcomes (11)
Clinical remission
overall mayo score ≤2 [and no individual subscore >1]
Measured: From baseline to 8 years
Clinical response
defined as the reduction of baseline scores by ≥3 points
Measured: From baseline to 8 years
Change from baseline in the Truelove and Witts Severity Index
Truelove and Witts Severity Index
Measured: From baseline to 8 years
Endoscopic remission
defined as Mayo endoscopic score ≤ 1
Measured: From baseline to 8 years
Fecal calprotectin levels
fecal sample
Measured: From baseline to 8 years
erythrocyte sedimentation rate levels
blood sample
Measured: From baseline to 8 years
C reactive protein levels
blood sample
Measured: From baseline to 8 years
Inflammatory Bowel Disease Questionnaire Score
The range of Inflammatory Bowel Disease Questionnaire Score is 32-224, and higher scores mean worse outcome
Measured: From baseline to 8 years
Hospital Anxiety and Depression scale score
The range of Hospital Anxiety and Depression scale score is 0-21, and higher scores mean worse outcome
Measured: From baseline to 8 years
Gut microbiota profile
fecal sample
Measured: From baseline to 8 years
The Pittsburgh Sleep Quality Index
higher scores mean worse outcome
Measured: From baseline to 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start2 Aug 2025
- Primary completion1 Dec 2032 (estimated)
- Study completion1 Dec 2032 (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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07114159
- Sponsor's protocol ID
- KY20232100-extension
- Status last verified
- Aug 2025
- First submitted
- 4 Aug 2025
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Clinical Trial to Evaluate the Long-term Safety and Efficacy of Sacral Nerve Stimulation in Patients With Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT07114159
- Acronym / sponsor ID
- KY20232100-extension
- Conditions
- Ulcerative Colitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 2 Aug 2025 (actual)
- Primary completion
- 1 Dec 2032 (estimated)
- Study completion
- 1 Dec 2032 (estimated)
- First posted
- 11 Aug 2025 (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 clinical trial is to evaluate the long-term 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: Sacral nerve stimulation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Sacral nerve stimulationDevice: G132 system, Beijing PINS Medical Co., China Neuromodulation was performed according to the usual protocol | Device | Sacral nerve stimulation |
Primary outcome
Change from baseline in the Mayo score
Time frame: From baseline to 8 years
The range of Mayo score is 0-12, and higher scores mean worse outcome
11 secondary outcomes
Clinical remission
Time frame: From baseline to 8 years
Clinical response
Time frame: From baseline to 8 years
Change from baseline in the Truelove and Witts Severity Index
Time frame: From baseline to 8 years
Endoscopic remission
Time frame: From baseline to 8 years
Fecal calprotectin levels
Time frame: From baseline to 8 years
erythrocyte sedimentation rate levels
Time frame: From baseline to 8 years
C reactive protein levels
Time frame: From baseline to 8 years
Inflammatory Bowel Disease Questionnaire Score
Time frame: From baseline to 8 years
Hospital Anxiety and Depression scale score
Time frame: From baseline to 8 years
Gut microbiota profile
Time frame: From baseline to 8 years
The Pittsburgh Sleep Quality Index
Time frame: From baseline to 8 years
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 11 Aug 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sacral nerve stimulation 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 11 Aug 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 (15529202305, 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 (time frame: From baseline to 8 years). 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 11 Aug 2025.