Status:
RECRUITING
Electro-acupuncture for Irritable Bowel Syndrome With Constipation
Lead Sponsor:
Nanyang Technological University
Collaborating Sponsors:
National University of Singapore
Conditions:
Irritable Bowel Syndrome With Constipation
Eligibility:
All Genders
21-65 years
Phase:
NA
Brief Summary
The aim of the clinical trial is to evaluate the efficacy and safety of electro-acupuncture for irritable bowel syndrome with constipation (IBS-C) patients. 60 IBS-C patients will be randomized and al...
Detailed Description
I) Study period: 14 weeks, including 2 weeks of run-in (wash-out), 6 weeks of treatment, and 6 weeks of follow-up. 15 visits will be scheduled for each participant, comprising 2 visits during recruit...
Eligibility Criteria
Inclusion
- Fulfilment of the Rome IV criteria for IBS-C;
- Age of 21 to 65 years (inclusive);
- Weekly average of worst daily abdominal pain score of ≥3 (0-10 scale) for at least 12 weeks before the first visit and during screening period;
- \<3 complete spontaneous bowel movements (CSBMs) per week for at least 12 weeks before the first visit and during screening period;
- Written informed consent.
Exclusion
- Pregnancy or breast-feeding;
- Medical history of inflammatory bowel diseases, carbohydrate malabsorption, hormonal disorder, known allergies to food additives, and/or any other serious diseases;
- History of gastrointestinal tract segment removal or bariatric surgery for obesity;
- Appendectomy or cholecystectomy within the past 2 months, or other abdominal surgeries within the past 6 months prior to trial enrollment;
- Unstable medical conditions that could be associated with abdominal pain or discomfort and could potentially influence the assessments in this trial (e.g., chronic kidney disease, endometriosis, lactose intolerance);
- Diagnosed with primary severe mental illness;
- Patients who have received acupuncture treatment in last three months, or took concomitant medication with affect gastrointestinal motility or visceral sensation, such as antidiarrheal agent, antidepressant, narcotic analgesic, and anticholinergic;
- Alcoholism or drug abuse in past 1 year;
- Having needle phobia or allergy to acupuncture needle materials;
- Antibiotics and probiotics/prebiotics usage in the previous month;
- Participating in other clinical studies.
Key Trial Info
Start Date :
September 12 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06219707
Start Date
September 12 2024
End Date
December 1 2025
Last Update
May 23 2025
Active Locations (1)
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1
Nanyang Technological University, School of Biological Sciences
Singapore, Singapore, Singapore, 637551