Electro-acupuncture for Irritable Bowel Syndrome With Constipation (NCT06219707) | Clinical Trial Compass
RecruitingNot Applicable
Electro-acupuncture for Irritable Bowel Syndrome With Constipation
Singapore60 participantsStarted 2024-09-12
Plain-language 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 allocated to either the electro-acupuncture arm or the sham acupuncture arm. We hypothesize that electro-acupuncture would result in superior symptom improvement compared to sham acupuncture. In addition, biological samples (blood, urine, and stool) will be collected during the trial for future exploratory studies. These samples will be used to investigate changes in gut microbiota composition and related metabolites. These analyses aim to explore potential mechanistic links between electro-acupuncture interventions and clinical outcomes in subsequent research. Apart from the IBS-C participants, 30 healthy volunteers aged 21 to 65 years (inclusive) will be recruited to provide blood, urine, and stool samples. These samples will serve as a reference for comparative analyses with those from IBS-C patients before and after electro-acupuncture treatment. The healthy controls will not receive any interventions.
Who can participate
Age range21 Years – 65 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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;
What they're measuring
1
Responders have a decrease in the weekly average of worst abdominal pain scores of ≥30% compared with baseline and a weekly increase of ≥1 CSBM
Timeframe: Baseline (week 2), after treatment period (week 8), end of follow-up (week 14)
✕. 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;