Transcutaneous Electrical Acustimulation (TEA) for Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D): A Multicenter, Randomized, Sham-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Composite responder
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •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.
排除标准
- •Presence of organic gastrointestinal diseases (e.g., inflammatory bowel disease, celiac disease and gastrointestinal malignancy).
- •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.
研究组 & 干预措施
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.
干预措施: Portable stimulator (Device)
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.
干预措施: Portable stimulator (Device)
结局指标
主要结局
Composite responder
时间窗: 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.
次要结局
- 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.)
研究者
Yilin Wang
Dr.
First People's Hospital of Foshan