IBS, Diarrhea PredominantNCT07425145
Transcutaneous Electrical Acustimulation for IBS-D: A Multicenter Study
A study testing Portable stimulator in people with IBS, Diarrhea Predominant, run by First People's Hospital of Foshan at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- IBS, Diarrhea Predominant
- What is being tested?
- Portable stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2026to 28 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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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Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First People's Hospital of Foshan
Foshan, Guangdong, 528000
Yilin Wang, Dr., +86 18038863747, wyl627@126.com
About this study
Official title: 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.
- Conditions
- IBS, Diarrhea Predominant
- Being tested
- Portable stimulator
- Keywords
- Transcutaneous Electrical Acustimulation, Irritable Bowel Syndrome, Multicenter Clinical Trial
- Medical subject headings
- Ichthyosis Bullosa of Siemens, Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Portable stimulatorDevice
A pair of surface electrocardiogram electrodes was applied on skin. A watch-size digital stimulators was used to deliver electrical stimulation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Portable stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the end of the 4-week treatment period
Secondary outcomes (4)
Composite responder rates assessed 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.
Measured: At weeks 2 and 8
IBS-SSS
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).
Measured: Assessments of IBS-SSS will be performed at baseline and at weeks 2, 4, and 8.
IBS-QoL
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.
Measured: Assessments of IBS-QoL will be performed at baseline and at weeks 4 and 8.
The Hospital Anxiety and Depression Scale (HADS)
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.
Measured: Assessments of HADS will be performed at baseline and at weeks 2, 4, and 8.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion30 Nov 2027 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for IBS, Diarrhea PredominantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First People's Hospital of Foshan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yilin Wang, First People's Hospital of Foshan
- Investigators
- Jiande Chen, Prof., Study director, University of Michigan Medical School - Gastroenterology & Hepatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07425145
- Sponsor's protocol ID
- TEA-IBSD-MC-2026
- Status last verified
- Feb 2026
- First submitted
- 13 Feb 2026
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31327218Huang 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.
PubMed 35973183Hu 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.
PubMed 35088760Mearin 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.
PubMed 27144627
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Electrical Acustimulation (TEA) for Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D): A Multicenter, Randomized, Sham-Controlled Trial
- ClinicalTrials.gov ID
- NCT07425145
- Acronym / sponsor ID
- TEA-IBSD-MC-2026
- Conditions
- IBS, Diarrhea Predominant
- Keywords
- Transcutaneous Electrical Acustimulation, Irritable Bowel Syndrome, Multicenter Clinical Trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- First People's Hospital of FoshanUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 20 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TEA group | Experimental | Device: Portable stimulatorElectrical 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. |
| sham-TEA group | Sham comparator | Device: Portable stimulatorElectrodes 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Portable stimulatorA pair of surface electrocardiogram electrodes was applied on skin. A watch-size digital stimulators was used to deliver electrical stimulation. | Device | TEA group, sham-TEA group |
Primary outcome
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.
4 secondary outcomes
Composite responder rates assessed at weeks 2 and 8
Time frame: 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.
IBS-QoL
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Results publication: PubMed 31327218Gwee 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.
- Results publication: PubMed 35973183Huang 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.
- Results publication: PubMed 35088760Hu 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.
- Results publication: PubMed 27144627Mearin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jiande Chen, Prof. study director
University of Michigan Medical School - Gastroenterology & Hepatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Portable stimulator in people with IBS, Diarrhea Predominant, run by First People's Hospital of Foshan at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yilin Wang, Dr. (+86 18038863747, wyl627@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite responder (time frame: At the end of the 4-week treatment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07425145, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.