An interventional study of Portable stimulator in IBS, Diarrhea Predominant, sponsored by First People's Hospital of Foshan. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-02-20.
Sponsored by First People's Hospital of Foshan · Not applicable, Interventional, and Treatment
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.
24 studies on the registry are indexed under Ichthyosis Bullosa of Siemens; 6 are open to participants now.
This study's planned enrollment of 200 is above the median of 88 across 18 interventional studies indexed under Ichthyosis Bullosa of Siemens.
Browse Ichthyosis Bullosa of Siemens studies →First People's Hospital of Foshan is the lead sponsor of 10 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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 .
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Exclusion Criteria:1)Presence of organic gastrointestinal diseases (e.g., inflammatory bowel disease, celiac disease and gastrointestinal ).
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 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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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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.
Time frame: At the end of the 4-week treatment period
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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Assessments of HADS will be performed at baseline and at weeks 2, 4, and 8.
Plan to share: No
Start is estimated for Mar 2026; primary completion for Nov 2027, 20 months later.
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First People's Hospital of Foshan