Peppermint Oil for the Treatment of Irritable Bowel Syndrome or Functional Abdominal Pain in Children: the MINT Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 228
- 试验地点
- 3
- 主要终点
- Abdominal pain intensity response rate after 8 weeks of treatment
研究概览
简要总结
Peppermint oil has shown to be effective in the treatment of Irritable Bowel Syndrome (IBS) symptoms in adults. Few studies of low quality are performed in an paediatric setting. Therefore, the investigators will conduct a multicenter randomized, placebo controlled trial to investigate the effects of an eight-week peppermint oil treatment in paediatric IBS or Functional Abdominal Pain - Not otherwise specified (FAP-NOS) patients.
详细描述
The objective of the MINT study is to investigate the effectiveness of peppermint oil capsules compared to placebo capsules in reducing abdominal pain intensity in children with IBS or FAP-NOS. In addition, we evaluate the effect of peppermint oil capsules compared to placebo capsules on other disease-related outcome measures such as anxiety & depression, quality of life, absenteeism from school, and healthcare costs. The second aim is to explore the effectiveness of regular mints in reducing abdominal pain intensity compared to peppermint oil capsules and placebo capsules and the effect of mints on secondary outcome parameters.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Peppermint oil capsules and placebo are double blinded, peppermint sweets are open-label
入排标准
- 年龄范围
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged between 8 years and 18 years
- •Diagnosis of IBS or FAP-NOS according to the Rome IV criteria. According to these criteria, organic disorders will be ruled out after routine laboratory testing initiated by their general practitioner or treating physician as part of standard of care. In patients without alarm symptoms only celiac screening (anti-transglutaminase antibodies and IgA), and faecal calprotectin are necessary.37 In patients with diarrhea faecal testing for Giardia Lambliae will be added. If alarm symptoms are present, further diagnostic testing (like a full blood count, CRP, liver tests or an ultrasound) to rule out an organic disorder, is left to the discretion of the treating physician.
- •An average daily pain rate of ≥ 3 of 10 on the Wong Baker Faces Pain Scale (This is a validated pain scale to measure pain intensity).
- •Informed Consent by both parents and by children aged ≥ 12 years. No informed consent from parents is necessary for children >16 years.
排除标准
- •Current treatment by another health care professional for abdominal symptoms
- •Previous use of peppermint oil for these abdominal complaints
- •Known hypersensitivity to mints or peppermint oil
- •Gastrointestinal blood loss
- •Recurrent or unexplained fevers
- •Decreased growth velocity
- •History of previous abdominal surgeries in the past 3 months
- •Significant chronic health condition requiring specialty care (e.g., lithiasis, ureteropelvic junction obstruction, sickle cell, cerebral palsy, hepatic, hematopoietic, renal, endocrine, or metabolic diseases) that could potentially impact the child's ability to participate or confound the results of the study
- •Known concomitant organic gastrointestinal disease
- •Current use of drugs which influence gastrointestinal motility, such as erythromycin, azithromycin, butyl scopolamine, domperidone, mebeverine and Iberogast. If laxatives are being used (in patients with IBS-C) they can continue using them during the study.
- •Current use of proton-pump inhibitors
- •Insufficient knowledge of the Dutch language
- •Pregnancy or current lactation. Women with childbearing potential must have a negative urine pregnancy test within 7 days prior to first dose of study treatment
研究组 & 干预措施
Peppermint oil capsules (Tempocol®)
Enteric-coated capsule containing 182mg of Peppermint Oil that release the oil in the small intestine, to be taken orally.
Age: 8-11 years old: 2 times daily for 8 weeks, if needed upped to 3 times daily after 4 weeks Age: 12-18: 3 times daily for 8 weeks, if needed upped to 3 times two capsules daily after 4 weeks
干预措施: Small intestinal release peppermint oil (Drug)
Placebo
Capsule containing microcrystalline cellulose, to be taken orally. Age: 8-11 years old: 2 times daily for 8 weeks, if needed upped to 3 times daily after 4 weeks Age: 12-18: 3 times daily for 8 weeks, if needed upped to 3 times two capsules daily after 4 weeks
干预措施: Placebo (Drug)
Peppermint sweets (Wilhelmina®)
Wilhelmina® peppermints contain 9.2 mg of Menthae Piperitae Aetheroleum (peppermint oil), and 18.4 Kcal per mint and are to be taken orally.
Age: 8-11 years old: 2 times daily for 8 weeks, if needed upped to 3 times daily after 4 weeks Age: 12-18: 3 times daily for 8 weeks, if needed upped to 3 times two capsules daily after 4 weeks
干预措施: Peppermint sweets (Drug)
结局指标
主要结局
Abdominal pain intensity response rate after 8 weeks of treatment
时间窗: 8 weeks
The proportion of patients with ≥ 30% reduction of their abdominal pain intensity after 8 weeks of therapy compared to baseline. This will be assessed by a smartphone diary app, on which patients record daily at the end of the day the intensity of their abdominal pain during a period of 7 consecutive days using a 10 point Likert scale/Wong-Baker faces scale. A score of 0 correlates with no pain and a score of 10 correlates with the worst imaginable pain. The intensity scores of 7 days will be summed up.
次要结局
- Expectancy of treatment(0 weeks)
- School absences during the treatment(4 weeks, 8 weeks, 12 weeks)
- Use of pain rescue medication during the treatment(4 weeks, 8 weeks, 12 weeks)
- Change in defecation pattern(4 weeks, 8 weeks, 12 weeks)
- Adequate relief(4 weeks, 8 weeks, 12 weeks)
- Health status(8 weeks)
- Costs(8 weeks, 12 weeks)
- Safety of peppermint oil(4 weeks, 8 weeks, 12 weeks)
- Ease of use of peppermint oil capsules, placebo capsules or peppermint sweets(8 weeks)
- Taste of peppermint oil capsules, placebo capsules or peppermint sweets(8 weeks)
- Placebo genes(0 weeks)
- Change in depression and anxiety score(8 weeks)
- Change in pain duration(4 weeks, 8 weeks, 12 weeks)
- Change in pain frequency(4 weeks, 8 weeks, 12 weeks)
- Change in abdominal pain intensity(4 weeks, 8 weeks, 12 weeks)
- Change in Quality of Life(8 weeks)
研究者
Koen Vermeijden
MD
St. Antonius Hospital