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Transcutaneous Electrical Acustimulation for IBS-D: A Multicenter Study

StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
Irritable bowel syndrome (IBS) is a functional gastrointestinal disorder characterized by recurrent abdominal pain and altered bowel habits. Under the Rome IV criteria, IBS can be classified into constipation-predominant (IBS-C), diarrhea-predominant (IBS-D), mixed (IBS-M), and unclassified (IBS-U) subtypes. IBS-D represents one of the most clinically disruptive phenotypes due to the combined burden of abdominal pain and frequent loose stools1. These symptoms are the major drivers of impaired quality of life and healthcare utilization. Despite available pharmacologic treatments, recurrence rates remain high and adverse effects often limit patient satisfaction, creating an unmet need for safe and effective alternative therapies. Transcutaneous Electrical Acustimulation (TEA) is an emerging therapy which delivers appropriate electrical stimulation to acupoints that are in the vicinity of peripheral nerves through surface electrodes, has been demonstrated to improve bowel symptoms and visceral hypersensitivity by modulating autonomic function and brain-gut interaction2. Previous trials of TEA in IBS have shown improvement in bowel symptoms, pain, and quality of life, with good safety and tolerability2,3. However, multicenter evidence for IBS-D is lacking. This trial aims to evaluate whether TEA can improve overall symptoms in patients with IBS-D. Specifically, the primary objective is to assess the effect of TEA on the composite responder rate, defined by concurrent improvement in both abdominal pain and loose stool days. Secondary objectives include evaluating broader symptom severity, stool characteristics, as well as on quality of life, psychological symptoms, and the durability of clinical benefits during follow-up.
Trial Details
NCT Number NCT07425145
Lead Sponsor First People's Hospital of Foshan
Conditions
(from sponsor)
IBS, Diarrhea Predominant
Related terms Ichthyosis Bullosa of Siemens, Irritable Bowel Syndrome
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov