Could a tiny electrical patch ease IBS-D symptoms?
NCT ID NCT07425145
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether a small, watch-sized device that delivers mild electrical stimulation to the skin can improve symptoms in people with diarrhea-predominant irritable bowel syndrome (IBS-D). Researchers will compare the real device to a sham (fake) version in 200 adults aged 18-65. The goal is to see if it reduces abdominal pain and the number of days with loose stools.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- transcutaneous electrical acustimulation (TEA) via a portable stimulator
- What this could lead to
- If it works, this could offer a safe, drug-free option to reduce abdominal pain and diarrhea in people with IBS-D.
- What could go wrong
- This is an early-stage trial with no phase, and the sham control may show no difference. Results may not apply to all IBS-D patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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. \-
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The First People's Hospital of Foshan
Foshan, Guangdong, 528000, China
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