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

Primary Purpose

Ulcerative Colitis

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

G132 system, Beijing PINS Medical Co., China

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring Ulcerative colitis, sacral nerve stimulation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Xijing HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sacral nerve stimulation

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Clinical remission at Week 12, 24, and 52

overall score ≤2 [and no individual subscore >1]

Clinical response at Week 12, 24, and 52

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

Truelove and Witts Severity Index

Endoscopic remission at Week 12, 24, and 52

defined as Mayo endoscopic score ≤ 1

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

fecal sample

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

blood sample

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

blood sample

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

blood sample

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

blood sample

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

blood sample

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

blood sample

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

blood sample

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

blood sample

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

blood sample

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

blood sample

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

blood sample

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

blood sample

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

blood sample

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

blood sample

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

blood sample

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

blood sample

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

Intestinal mucosal tissue sample

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

Intestinal mucosal tissue sample

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

Intestinal mucosal tissue sample

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

Intestinal mucosal tissue sample

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.

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

fecal sample metabolites analysis

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

fecal sample microbiota analysis

autonomic profile characteristics

heart rate variability indicating sympathetic and parasympathetic activity

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.

Functional magnetic resonance imaging

blood oxygen level dependent，BOLD-fMRI

Full Information

NCT ID

NCT05895981

First Posted

May 15, 2023

Last Updated

August 18, 2023

Sponsor

Xijing Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05895981

Brief Title

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

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 20, 2023 (Actual)

Primary Completion Date

January 1, 2025 (Anticipated)

Study Completion Date

March 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Xijing Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ulcerative Colitis

Keywords

Ulcerative colitis, sacral nerve stimulation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Sacral nerve stimulation

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

G132 system, Beijing PINS Medical Co., China

Intervention Description

Neuromodulation was performed according to the usual protocol

Primary Outcome Measure Information:

Title

Change from baseline in the Mayo score at week 12

Description

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.

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

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

Description

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.

Time Frame

24 and 52 weeks

Title

Clinical remission at Week 12, 24, and 52

Description

overall score ≤2 [and no individual subscore >1]

Time Frame

12, 24, and 52 weeks

Title

Clinical response at Week 12, 24, and 52

Description

defined as the reduction of baseline scores by ≥3 points

Time Frame

12, 24, and 52 weeks

Title

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

Description

Truelove and Witts Severity Index

Time Frame

12, 24, and 52 weeks

Title

Endoscopic remission at Week 12, 24, and 52

Description

defined as Mayo endoscopic score ≤ 1

Time Frame

12, 24, and 52 weeks

Title

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

Description

fecal sample

Time Frame