NCT07290816Not yet recruitingNot Applicable
Effect of Non-invasive Neuromodulation on the Quality of Bowel Cleansing: a Randomized, Controlled, Double-blind Clinical Study
Shanghai East Hospital1 site in 1 country270 target enrollmentStarted: December 31, 2025Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 270
- Locations
- 1
- Primary Endpoint
- Bowel Preparedness Score
Study Overview
Brief Summary
To clarify whether non-invasive neuromodulation for assisted bowel preparation can improve the quality of bowel preparation, to explore the possible mechanisms by which TEA improves the quality of bowel preparation, and to assess its safety, as well as subjects' tolerance, compliance and satisfaction.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 78 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18 to 78 years of age, male or female;
- •Intended to undergo diagnostic, screening, or surveillance colonoscopy;
- •Signed written informed consent.
Exclusion Criteria
- •Severe cardiac, cerebral, pulmonary, or renal complications or a history of acute cardiac infarction within six months;
- •High risk factors for bowel preparation such as history of colon surgery, BMI ≥ 28, inflammatory bowel disease, constipation (less than 3 bowel movements in the last week, and with straining to defecate, with hard stools and small amount of stools) or bowel obstruction;
- •High suspicion of colorectal cancer by auxiliary examination or early warning signs and symptoms of colorectal cancer: blood in stool, black stool, unexplained anemia, significant weight loss, abdominal mass and positive rectal fingerprinting;
- •The presence of surgical incisions or scars in the area where the electrostimulation treatment tablets are pasted, or near the ST36 acupoints on both legs;
- •Are participating in other clinical observation trials or have participated in other clinical trials within 30 days.
Outcomes
Primary Outcomes
Bowel Preparedness Score
Time Frame: Day 2
Using the Boston Bowel Preparation Scale(BBPS)
Secondary Outcomes
- Polyp detection rate(Day 2)
- Adenoma detection rate(Day 2)
- Adverse reactions(Baseline and Day 2)
- Complete Blood Count(Baseline and Day 2)
- C-Reactive Protein(Baseline and Day 2)
- Inflammatory Cytokines(TNF-α，IL-6，IL-10……)(Baseline and Day 2)
- Gastrointestinal Hormones (Pancreatic Polypeptide, Motilin, Vasoactive Intestinal Peptide……)(Baseline and Day 2)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Recruiting
Phase 4
A trial to compare efficacy and tolerability of Plenvu® and Picoprep® as cleansing agents of the large bowel before colonoscopy (examination of
the bowel with a fiberoptic device)2024-518544-21-00Aalborg University Hospital400
Not yet recruiting
Not Applicable
Enhanced Ward Rounds for Bowel Preparation Quality in Hospitalized Patients Undergoing ColonoscopyNCT07263867LanZhou University300
Completed
Not Applicable
Verification study of Bowel Movement Improvement by Amazake Consumptioot applicableJPRN-UMIN000036196Morinaga & CO., LTD.38
Completed
Not Applicable
Examination of bowel movement improving effect of yogurtHealthy adultJPRN-UMIN000043902EP Mediate Co., Ltd.22
Not yet recruiting
Unknown
Bowel Preparation Quality and Computer-aided Detection for screening and Surveillance ColonoscopyFactors influencing health status and contact with health servicesKCT0008936Asan Medical Center675