Electro-acupuncture for treating constipation in IBS patients

Electro-acupuncture for Irritable Bowel Syndrome With Constipation: a Pilot, Randomized, Double-blinded, Sham-controlled Trial

This study is testing if electro-acupuncture can help people with irritable bowel syndrome and constipation feel better compared to a fake treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 21 Years to 65 Years
• Sex: All
• Sponsor: Nanyang Technological University (Academic / other)
• Locations: 1 site (Singapore, Singapore)
• Trial ID: NCT06219707 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of electro-acupuncture in patients with irritable bowel syndrome with constipation (IBS-C). A total of 60 participants will be randomly assigned to receive either electro-acupuncture or sham acupuncture over a 6-week treatment period, followed by 6 weeks of follow-up. The study will also collect biological samples from participants and healthy volunteers to explore changes in gut microbiota and metabolites, aiming to uncover potential mechanisms behind the treatment's effects. The trial employs a patient-blind technique to ensure unbiased results.

Who should consider this trial

Good fit: Ideal candidates are adults aged 21 to 65 who meet the Rome IV criteria for IBS-C and experience significant abdominal pain and constipation.

Not a fit: Patients with serious gastrointestinal conditions or recent abdominal surgeries may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a non-pharmacological option for improving symptoms in IBS-C patients.

How similar studies have performed: Previous studies have shown promising results for acupuncture in treating IBS symptoms, suggesting potential success for this approach.

Eligibility criteria

Inclusion Criteria:

1. Fulfilment of the Rome IV criteria for IBS-C;
2. Age of 21 to 65 years (inclusive);
3. 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;
4. \<3 complete spontaneous bowel movements (CSBMs) per week for at least 12 weeks before the first visit and during screening period;
5. Written informed consent.

Exclusion Criteria:

1. Pregnancy or breast-feeding;
2. Medical history of inflammatory bowel diseases, carbohydrate malabsorption, hormonal disorder, known allergies to food additives, and/or any other serious diseases;
3. History of gastrointestinal tract segment removal or bariatric surgery for obesity;
4. Appendectomy or cholecystectomy within the past 2 months, or other abdominal surgeries within the past 6 months prior to trial enrollment;
5. 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);
6. Diagnosed with primary severe mental illness;
7. 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;
8. Alcoholism or drug abuse in past 1 year;
9. Having needle phobia or allergy to acupuncture needle materials;
10. Antibiotics and probiotics/prebiotics usage in the previous month;
11. Participating in other clinical studies.

Where this trial is running

Singapore, Singapore

• Nanyang Technological University, School of Biological Sciences — Singapore, Singapore, Singapore (Recruiting)

Study contacts

• Principal investigator: Linda LD Zhong, PhD — Nanyang Technological University
• Study coordinator: Linda LD Zhong, MD., PhD

Conditions Irritable Bowel Syndrome With Constipation; Acupuncture; Irritable Bowel Syndrome with Constipation; Microbiota