Transcutaneous Electrical Acustimulation for IBS-D: A Multicenter Study

February 13, 2026 updated by: Yilin Wang, First People's Hospital of Foshan

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Yilin Wang, Dr.
  • Phone Number: +86 18038863747
  • Email: wyl627@126.com

Study Locations

  • China
    • Guangdong
      • Foshan, Guangdong, China, 528000
        • The First People's Hospital of Foshan
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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: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.

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TEA group
Electrical stimulation will be applied unilaterally at the ST36 (Zusanli) acupoints.Electrical stimulation will be delivered using a watch-sized portable stimulator. The stimulation will be delivered using two sets of parameters: an anti-pain mode (0.1-second on-time, 0.4-second off-time, 0.5 ms pulse width, 100 Hz) for the first 30 minutes, followed by an anti-inflammatory mode (10-second on-time, 90-second off-time, 0.3 ms pulse width, 5 Hz) for the subsequent 30 minutes. The current amplitude will range from 1 to 10 mA and will be gradually adjusted to the maximum level tolerated by the participant.TEA will be performed for 1 hour per session, twice daily, once in the morning and once in the evening. The total treatment duration will be 4 weeks.
Device: Portable stimulator
A pair of surface electrocardiogram electrodes was applied on skin. A watch-size digital stimulators was used to deliver electrical stimulation.
Sham Comparator: sham-TEA group
Electrodes will be placed at non-acupoint locations that are not situated along any recognized meridian. The sham stimulation site will be located on the lateral aspect of the forearm, approximately two finger breadths lateral to the midpoint of the cubital crease.Electrical stimulation will be delivered using a watch-sized portable stimulator. The stimulation will be delivered using two sets of parameters: an anti-pain mode (0.1-second on-time, 0.4-second off-time, 0.5 ms pulse width, 100 Hz) for the first 30 minutes, followed by an anti-inflammatory mode (10-second on-time, 90-second off-time, 0.3 ms pulse width, 5 Hz) for the subsequent 30 minutes. The current amplitude will range from 1 to 10 mA and will be gradually adjusted to the maximum level tolerated by the participant. Sham-TEA will be performed for 1 hour per session, twice daily, once in the morning and once in the evening. The total treatment duration will be 4 weeks.
Device: Portable stimulator
A pair of surface electrocardiogram electrodes was applied on skin. A watch-size digital stimulators was used to deliver electrical stimulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At the end of the 4-week treatment period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At weeks 2 and 8
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).
Assessments of IBS-SSS will be performed at baseline and at weeks 2, 4, and 8.
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.
Assessments of IBS-QoL will be performed at baseline and at weeks 4 and 8.
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.
Assessments of HADS will be performed at baseline and at weeks 2, 4, and 8.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First People's Hospital of Foshan

Investigators

  • Study Director: Jiande Chen, Prof., University of Michigan Medical School - Gastroenterology & Hepatology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

November 30, 2027

Study Completion (Estimated)

February 28, 2028

Study Registration Dates

First Submitted

February 13, 2026

First Submitted That Met QC Criteria

February 13, 2026

First Posted (Actual)

February 20, 2026

Study Record Updates

Last Update Posted (Actual)

February 20, 2026

Last Update Submitted That Met QC Criteria

February 13, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TEA-IBSD-MC-2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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