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NCT Number: NCT07425145

Transcutaneous Electrical Acustimulation for IBS-D: A Multicenter Study

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.

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Key information

Conditions

IBS, Diarrhea Predominant Colonic Diseases Colonic Diseases, Functional Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Gastrointestinal Diseases Genetic Diseases, Inborn Ichthyosis Ichthyosis Bullosa of Siemens Infant, Newborn, Diseases Intestinal Diseases Irritable Bowel Syndrome Keratosis Skin Abnormalities Skin Diseases Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

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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.

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Treatment and study plan

Portable stimulator

Device

A pair of surface electrocardiogram electrodes was applied on skin. A watch-size digital stimulators was used to deliver electrical stimulation.

Primary outcomes

  1. Composite responder

    Time frame: At the end of the 4-week treatment period

    Abdominal pain or discomfort responder if the weekly average of the daily worst APS or ADS (past 24 hours) decreases by ≥30% from baseline. For participants with both abdominal pain and abdominal discomfort, responder status will be determined based on the symptom with the higher baseline score. stool consistency responder if the number of days per week with at least one stool of Bristol Stool Form Scale type 6 or 7 is reduced by ≥50% from baseline. Only participants who simultaneously meet both criteria will be considered primary endpoint responders.

Secondary outcomes

  1. Composite responder rates assessed at weeks 2 and 8

    Time frame: At weeks 2 and 8

    Abdominal pain or discomfort responder if the weekly average of the daily worst APS or ADS (past 24 hours) decreases by ≥30% from baseline. For participants with both abdominal pain and abdominal discomfort, responder status will be determined based on the symptom with the higher baseline score. stool consistency responder if the number of days per week with at least one stool of Bristol Stool Form Scale type 6 or 7 is reduced by ≥50% from baseline. Only participants who simultaneously meet both criteria will be considered primary endpoint responders.

  2. IBS-SSS

    Time frame: Assessments of IBS-SSS will be performed at baseline and at weeks 2, 4, and 8.

    This questionnaire consists of five components: severity and frequency of abdominal pain, severity of abdominal distension, dissatisfaction with bowel habits, and interference with daily life, each scored from 0 to 100, yielding a total score between 0 and 500. According to the total score, IBS severity is categorized as mild (75-175), moderate (175-300), or severe (>300).

  3. IBS-QoL

    Time frame: Assessments of IBS-QoL will be performed at baseline and at weeks 4 and 8.

    The IBS-QoL includes 34 items covering eight domains: dysphoria, interference with activity, body image, health worry, food avoidance, social reaction, sexual activity, and relationships. Each item is rated on a 5-point scale, and the total score will be converted to a 0-100 scale, where higher values indicate better quality of life, using the formula: (actual raw score - lowest possible score) / possible score range × 100.

  4. The Hospital Anxiety and Depression Scale (HADS)

    Time frame: Assessments of HADS will be performed at baseline and at weeks 2, 4, and 8.

    It consists of 14 items, divided into two subscales: HADS-A (anxiety) and HADS-D (depression), with 7 items each. Each item is scored from 0 to 3, yielding subscale scores ranging from 0 to 21. Higher scores indicate greater symptom severity.

Study contacts

Contact information is provided by the study sponsor or research team.

Yilin Wang, Dr.

CONTACT

[email protected]

+86 18038863747

Sponsors and collaborators

Lead sponsor

First People's Hospital of Foshan

Other

Registry information

Official study title

Transcutaneous Electrical Acustimulation (TEA) for Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D): A Multicenter, Randomized, Sham-Controlled Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Feb 20, 2026
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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