Transcutaneous Electrical Acustimulation for IBS-D: A Multicenter Study

NCT07425145 | Not Yet Recruiting DMC

• 1 other identifier: TEA-IBSD-MC-2026
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

IBS, Diarrhea Predominant

Keywords

Transcutaneous Electrical Acustimulation; Irritable Bowel Syndrome; Multicenter Clinical Trial

Outcome Measures

Primary Outcomes (1)

• Composite responder

  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 Outcomes (4)

• Composite responder rates assessed at weeks 2 and 8

  At weeks 2 and 8

• IBS-SSS

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

• IBS-QoL

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

• The Hospital Anxiety and Depression Scale (HADS)

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

Study Arms (2)

TEA group

EXPERIMENTAL

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

sham-TEA group

SHAM COMPARATOR

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

Interventions

Portable stimulator DEVICE

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

TEA group; sham-TEA group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• )Mean daily abdominal pain score (APS) or abdominal discomfort score (ADS) ≥ 3 on a 0-10 Numerical Rating Scale (NRS) in the last week.
• )Type 6 or 7 of the Bristol Stool Form Scale (BSFS) appeared for at least 2 days in the last weeks.
• )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.
• )Willingness and ability to comply with all study procedures, and provide written informed consent.

You may not qualify if:

• )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.
• )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.
• )Implanted electrical devices (e.g., cardiac pacemaker, defibrillator) or other active implants that may be affected by electrical stimulation.
• )Local skin disease or infection at the stimulation site, severe dermatologic sensitivity to electrodes or adhesives.
• )Participants who are familiar with acupuncture acupoints and may therefore compromise study blinding will be excluded.
• )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.
• )Participation in another clinical trial within the past 3 months or currently enrolled in another interventional study.

Sponsors & Collaborators

• First People's Hospital of Foshan: lead

Study Sites (1)

The First People's Hospital of Foshan

Foshan, Guangdong, 528000, China

Location

Related Publications (4)

• Gwee KA, Gonlachanvit S, Ghoshal UC, Chua ASB, Miwa H, Wu J, Bak YT, Lee OY, Lu CL, Park H, Chen M, Syam AF, Abraham P, Sollano J, Chang CS, Suzuki H, Fang X, Fukudo S, Choi MG, Hou X, Hongo M. Second Asian Consensus on Irritable Bowel Syndrome. J Neurogastroenterol Motil. 2019 Jul 1;25(3):343-362. doi: 10.5056/jnm19041.

  PMID: 31327218 RESULT

• Huang Z, Lin Z, Lin C, Chu H, Zheng X, Chen B, Du L, Chen JDZ, Dai N. Transcutaneous Electrical Acustimulation Improves Irritable Bowel Syndrome With Constipation by Accelerating Colon Transit and Reducing Rectal Sensation Using Autonomic Mechanisms. Am J Gastroenterol. 2022 Sep 1;117(9):1491-1501. doi: 10.14309/ajg.0000000000001882. Epub 2022 Jun 10.

  PMID: 35973183 RESULT

• Hu P, Sun K, Li H, Qi X, Gong J, Zhang Y, Xu L, Lin M, Fan Y, Chen JDZ. Transcutaneous Electrical Acustimulation Improved the Quality of Life in Patients With Diarrhea-Irritable Bowel Syndrome. Neuromodulation. 2022 Dec;25(8):1165-1172. doi: 10.1016/j.neurom.2021.10.009. Epub 2021 Dec 18.

  PMID: 35088760 RESULT

• Mearin F, Lacy BE, Chang L, Chey WD, Lembo AJ, Simren M, Spiller R. Bowel Disorders. Gastroenterology. 2016 Feb 18:S0016-5085(16)00222-5. doi: 10.1053/j.gastro.2016.02.031. Online ahead of print.

  PMID: 27144627 RESULT

MeSH Terms

Conditions

Ichthyosis Bullosa of Siemens; Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Ichthyosis; Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Genetic Diseases, Inborn; Infant, Newborn, Diseases; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Jiande Chen, Prof.

  University of Michigan Medical School - Gastroenterology & Hepatology

  STUDY DIRECTOR

Central Study Contacts

Yilin Wang, Dr.

CONTACT

+86 18038863747; wyl627@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: February 13, 2026
• First Posted: February 20, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): February 28, 2028
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)