Diarrhea-predominant irritable bowel syndrome
Conditions
Interventions
TEA Group (Transcutaneous Electrical Acupuncture Group):Electrodes placed at Zusanli acupoint
same model portable stimulator used, twice daily (morning and evening), 60 minutes per session, continuous treatment for 4 weeks. Stimulation parameters (pulse width, frequency, duty cycle) fixed, int
Sham Stimulation Group (Sham TEA Group):Same model device used, but electrodes placed on non-acupoint areas
sham stimulation with no physiological effect provided. Appearance, packaging, and operation procedures identical to TEA group. Twice daily, 60 minutes per session, continuous treatment for 4 weeks.
Sponsors
The First People's Hospital of Foshan
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Adults aged 18–65 years of either sex. 2. Diagnosis of diarrhea-predominant irritable bowel syndrome (IBS-D) will according to modified Rome IV criteria based on Asian consensus4: recurrent abdominal pain or discomfort (an unpleasant or bothersome sensation that is not described by the patient as pain, including fullness, bloating, or pressure), on average, at least 1 day per week in the last 3 months, associated with two or more of the following–related to defecation, associated with a change in stool frequency, or associated with a change in stool form–with symptom onset at least 6 months before diagnosis. 3. Mean daily abdominal pain score (APS) or abdominal discomfort score (ADS) >= 3 on a 0–10 Numerical Rating Scale (NRS) in the last week. 4. Type 6 or 7 of the Bristol Stool Form Scale (BSFS) appeared for at least 2 days in the last weeks. 5. Colonoscopy performed within the past 3 years without evidence of organic gastrointestinal disease. Patients with colonic polyps or colonic diverticula may be included, provided there are no related complications. 6. Willingness and ability to comply with all study procedures, and provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Presence of organic gastrointestinal diseases (e.g., inflammatory bowel disease, celiac disease and gastrointestinal malignancy). 2. Patients who cannot commit to abstaining from any IBS-targeted medications (e.g., antidiarrheals, antispasmodics, rifaximin, 5-HT3 antagonists, opioid analgesics, or other agents affecting bowel habits or visceral pain perception) or centrally acting drugs (Antidepressants or anxiolytics) throughout the study period. Patients with long-term stable use (at least 3 months) of probiotics/synbiotics who do not intend to change their regimen during the treatment period may be included. 3. Prior major abdominal surgery (except appendectomy, cholecystectomy). 4. Severe cerebrocardiovascular diseases, impaired hepatic or renal function indicating organ failure, uncontrolled diabetes or hyperthyroidism, or uncontrolled psychiatric disorders. 5. Implanted electrical devices (e.g., cardiac pacemaker, defibrillator) or other active implants that may be affected by electrical stimulation. 6. Local skin disease or infection at the stimulation site, severe dermatologic sensitivity to electrodes or adhesives. 7. Participants who are familiar with acupuncture acupoints and may therefore compromise study blinding will be excluded. 8. Pregnancy or lactation. Women of childbearing potential who cannot confirm non-pregnancy will be required to undergo a urine or serum hCG test during screening, those with positive results will be excluded. 9. Participation in another clinical trial within the past 3 months or currently enrolled in another interventional study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite symptom response rate (proportion achieving >=30% reduction in abdominal pain/discomfort score and >=50% reduction in days with Bristol Stool Form Scale 6–7);Safety outcomes (including adverse events, serious adverse events, cutaneous adverse reactions, vital signs, device usage); | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of composite symptom responders at Week 2 and Week 8 (follow-up end);Irritable Bowel Syndrome Severity Scoring System (IBS-SSS);Irritable Bowel Syndrome Quality of Life (IBS-QoL) score;Hospital Anxiety and Depression Scale (HADS) score;Abdominal Pain Score (APS) or Abdominal Discomfort Score (ADS);Bristol Stool Form Scale (BSFS) score and daily bowel movement frequency; | — |
Countries
China
Contacts
Public ContactWang Yilin
The First People's Hospital of Foshan
Outcome results
None listed