Clinical trial NCT05895981: Exploratory Clinical Trial of Safety and Efficacy of Sacral Nerve Stimulation in Patients With Ulcerative Colitis.
Official title: An Exploratory Clinical Trial to Evaluate the Safety and Efficacy of Sacral Nerve Stimulation in Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ulcerative Colitis
Keywords: Ulcerative colitis
sacral nerve stimulation
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2023-06-09
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in the Mayo score at week 12
timeFrame: 12 weeks
Secondary outcomes:
measure: Change from baseline in the Mayo score at week 24, and 52
timeFrame: 24 and 52 weeks
measure: Clinical remission at Week 12, 24, and 52
timeFrame: 12, 24, and 52 weeks
measure: Clinical response at Week 12, 24, and 52
timeFrame: 12, 24, and 52 weeks
measure: Change from baseline in the Truelove and Witts Severity Index at Week 12, 24, and 52
timeFrame: 12, 24, and 52 weeks
measure: Endoscopic remission at Week 12, 24, and 52
timeFrame: 12, 24, and 52 weeks
measure: Fecal calprotectin levels at baseline, week 4, 8, 12, 24 and 52
timeFrame: baseline, 4, 8, 12, 24, and 52 weeks
measure: erythrocyte sedimentation rate levels at baseline, week 4, 8, 12, 24 and 52
timeFrame: baseline, 4, 8, 12, 24, and 52 weeks
measure: C reactive protein levels at baseline, week 4, 8, 12, 24 and 52
timeFrame: baseline, 4, 8, 12, 24, and 52 weeks
measure: pancreatic polypeptide levels at baseline, week 4, 8, 12, 24 and 52
timeFrame: baseline, 4, 8, 12, 24, and 52 weeks
measure: norepinephrine levels at baseline, week 4, 8, 12, 24 and 52
timeFrame: baseline, 4, 8, 12, 24, and 52 weeks
measure: interleukin-1β levels at baseline, week 4, 8, 12, 24 and 52
timeFrame: baseline, 4, 8, 12, 24, and 52 weeks
measure: interleukin-2 levels at baseline, week 4, 8, 12, 24 and 52
timeFrame: baseline, 4, 8, 12, 24, and 52 weeks
measure: interleukin-4 levels at baseline, week 4, 8, 12, 24 and 52
timeFrame: baseline, 4, 8, 12, 24, and 52 weeks
measure: interleukin-5 levels at baseline, week 4, 8, 12, 24 and 52
timeFrame: baseline, 4, 8, 12, 24, and 52 weeks
measure: interleukin-6 levels at baseline, week 4, 8, 12, 24 and 52
timeFrame: baseline, 4, 8, 12, 24, and 52 weeks
measure: interleukin-8 levels at baseline, week 4, 8, 12, 24 and 52
timeFrame: baseline, 4, 8, 12, 24, and 52 weeks
measure: interleukin-10 levels at baseline, week 4, 8, 12, 24 and 52
timeFrame: baseline, 4, 8, 12, 24, and 52 weeks
measure: interleukin-12P70 levels at baseline, week 4, 8, 12, 24 and 52
timeFrame: baseline, 4, 8, 12, 24, and 52 weeks
measure: interleukin-17 levels at baseline, week 4, 8, 12, 24 and 52
timeFrame: baseline, 4, 8, 12, 24, and 52 weeks
measure: Tumor necrosis factor -α levels at baseline, week 4, 8, 12, 24 and 52
timeFrame: baseline, 4, 8, 12, 24, and 52 weeks
measure: Interferon-γ levels at baseline, week 4, 8, 12, 24 and 52
timeFrame: baseline, 4, 8, 12, 24, and 52 weeks
measure: Interferon-α levels at baseline, week 4, 8, 12, 24 and 52
timeFrame: baseline, 4, 8, 12, 24, and 52 weeks
measure: interleukin-10 levels in tissue sample at baseline, week 12, 24 and 52
timeFrame: baseline, 12, 24, and 52 weeks
measure: interleukin-17 levels in tissue sample at baseline, week 12, 24 and 52
timeFrame: baseline, 12, 24, and 52 weeks
measure: Tumor necrosis factor -α levels in tissue sample at baseline, week 12, 24 and 52
timeFrame: baseline, 12, 24, and 52 weeks
measure: acetyl choline levels at baseline, week 12, 24 and 52
timeFrame: baseline, 12, 24, and 52 weeks
measure: Inflammatory Bowel Disease Questionnaire Score at baseline, week 12, 24 and 52
timeFrame: baseline, 12, 24, and 52 weeks
measure: Gut metabolites profile at baseline, week 12, 24, and 52
timeFrame: baseline, 12, 24, and 52 weeks
measure: Gut microbiota profile at baseline, week 12, 24, and 52
timeFrame: baseline, 12, 24, and 52 weeks
measure: autonomic profile characteristics
timeFrame: baseline, 4, 8, 12, 24, and 36 weeks
measure: Hospital Anxiety and Depression scale score
timeFrame: baseline, 12, 24, and 52 weeks
measure: Functional magnetic resonance imaging
timeFrame: baseline and 24 weeks
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital
state: Shaanxi
Study officials:
affiliation: Air Force Military Medical University, China
name: Kaichun Wu, PhD
role: STUDY_CHAIR
References: