"A Non-Inferiority Randomized Controlled Trial of Enteric-Coated Peppermint Oil Versus Standard Antispasmodic in SLC6A4 (5-HTTLPR) Carriers With Irritable Bowel Syndrome."
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 224
- 试验地点
- 1
- 主要终点
- Irritable Bowel Syndrome
研究概览
简要总结
This study is a non-inferiority, double-blind, randomized controlled trial comparing enteric-coated peppermint oil with a standard antispasmodic (e.g., mebeverine) in adult IBS patients who carry at least one "S" allele in the SLC6A4 (5-HTTLPR) polymorphism. The primary goal is to see whether peppermint oil provides symptom relief (measured by IBS severity scores) that is not worse than the antispasmodic by more than a predefined margin (30 points on the IBS-SSS). Secondary goals include evaluating differences in abdominal pain, stool patterns, quality of life, and adverse event profiles, with a focus on peppermint oil's tolerability. About 224 participants (112 per arm) will be enrolled, with allowances for dropout, to detect non-inferiority at 80% power. After 12 weeks of treatment, results will inform whether peppermint oil is a viable, well-tolerated alternative to standard antispasmodics, especially in patients with heightened GI sensitivity linked to the SLC6A4 polymorphism.
详细描述
This double-blind, parallel-group, non-inferiority RCT will randomize ~250 adults (18-65 y) who meet Rome IV criteria for IBS and carry at least one short 5-HTTLPR (SLC6A4) allele to enteric-coated peppermint-oil capsules (180 mg three times daily) or the standard antispasmodic mebeverine (135 mg three times daily) for 12 weeks. Because the S-allele reduces serotonin-transporter expression and heightens visceral sensitivity, the study targets a genetically defined subgroup in which menthol's smooth-muscle-relaxing calcium-channel blockade may yield clinically meaningful benefit with fewer anticholinergic effects. Randomisation (1 : 1) is web-based, stratified by genotype and centre, and treatments are packaged identically to maintain blinding of participants, investigators, and outcome assessors. The primary endpoint is change from baseline in the IBS Severity Scoring System at week 12; non-inferiority is met if the upper bound of the two-sided 95 % CI for the treatment difference (peppermint - mebeverine) is ≤ +30 points. A mixed-model repeated-measures analysis will be applied to both intention-to-treat and per-protocol populations, providing 80 % power with ~112 evaluable patients per arm. Secondary outcomes include abdominal-pain intensity, stool form, quality of life, global satisfaction, and adverse events; safety is tracked via weekly contacts, laboratory tests, and an independent data-safety monitoring board. Demonstrating that peppermint oil is at least as effective as mebeverine while better tolerated would support its use as a genotype-guided first-line therapy for IBS.
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, Care Provider, 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.
- •Diagnosis of Irritable Bowel Syndrome by Rome IV criteria, with at least moderate severity (IBS-SSS ≥ 175).
- •SLC6A4 genotyping confirms at least one S allele (SS or SL).
- •Able and willing to provide informed consent and comply with study procedures.
排除标准
- •L/L genotype of 5-HTTLPR.
- •Known organic GI diseases (e.g., IBD, celiac disease).
- •Severe/unstable comorbidities (e.g., cardiac, hepatic, or renal dysfunction).
- •Use of peppermint oil, antispasmodics, or investigational drugs within 30 days prior to enrollment.
- •. Known hypersensitivity to peppermint or mebeverine.
- •Pregnancy or breastfeeding.
- •Significant psychiatric illness that, in the investigator's judgment, might interfere with participation.
研究组 & 干预措施
Enteric-coated peppermint oil capsules (~180 mg total peppermint oil/ capsule) to ensure release in
干预措施: Peppermint Oil (Dietary Supplement)
A standard antispasmodiс
A standard antispasmodic (e.g., mebeverine 135 mg).
干预措施: A standard antispasmodic (Drug)
结局指标
主要结局
Irritable Bowel Syndrome
时间窗: 12 weeks
Symptom severity in this trial is captured with the IBS-SSS (IBS Severity Scoring System): 0 = no symptoms to 500 = most severe symptoms
次要结局
- Numeric Rating Scale (for abdominal pain)(12 weeks)
- Abdominal Pain: Measured by visual analog score(12 weeks)
- Stool Consistency: Bristol Stool Form Scale(12 weeks)
- Quality of Life: Irritable Bowel Syndrome Quality of Life Questionnaire(12 weeks)
- Global Patient Satisfaction: Five-point Likert Scale(12 weeks)
- Quality of Life: 36-Item Short Form Health Survey(12 weeks)
- Adverse Events: Incidence(12 weeks)