Electro-acupuncture for Irritable Bowel Syndrome With Constipation

Launched by NANYANG TECHNOLOGICAL UNIVERSITY · Jan 12, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at the effects of a treatment called electro-acupuncture for people who have Irritable Bowel Syndrome with Constipation (IBS-C). The goal is to see if this method can help reduce abdominal pain and improve bowel movements in patients suffering from this condition. The trial will involve 60 participants who will be divided into two groups: one will receive real electro-acupuncture, while the other will receive a placebo treatment that does not involve real acupuncture.

To take part in the study, participants need to be between 21 and 65 years old and have been experiencing symptoms of IBS-C, such as significant abdominal pain and fewer than three complete bowel movements per week. Those who are pregnant, have certain medical conditions, or have had recent surgeries may not be eligible to join. If you participate, you can expect to attend several treatment sessions and be monitored for any changes in your symptoms throughout the trial. This study is currently recruiting participants, and it aims to gather more information on whether electro-acupuncture is a safe and effective option for relieving IBS-C symptoms.

Gender

ALL

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.