Peppermint Oil Pharmacokinetics/Dynamics and Novel Biological Signatures in Children With Functional Abdominal Pain
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pharmacokinetics
研究概览
简要总结
Aim 1 - Determine the pharmacokinetics of PMO (menthol) of three different doses in children with functional abdominal pain (FAP) (n=30).
Aim 2 - Determine pharmacodynamic effect of three different doses of PMO on gut microbiome composition and contractile activity/gut transit rate.
详细描述
Children with functional abdominal pain (FAP) ages 7-12 years (n=30) will be recruited.
The study participants will be admitted to the Children's Nutrition Research Center. A medical history and a general physical examination performed by the investigator or the research nurse. The height, weight, and vital signs (pulse rate, respiratory rate, and seated blood pressure) will be obtained. After application of a topical anesthetic to the site chosen for study-related blood sampling, a cannula will be inserted e to obtain repeated blood samples.
At approximately 0900, subjects will receive one of three doses of PMO as a single oral dose. Immediately prior to administration of the PMO, a blood sample will be obtained to measure total menthol concentration and leukocytes for isolation of DNA for CYP2A6 and UGT2B7 genotyping.
After PMO administration, repeated blood samples will be obtained over 24 hours.
At 2 hours after PMO administration, participants will be given a standardized meal and will eat ad libitum thereafter.
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
- None
入排标准
- 年龄范围
- 7 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children ages 7-12 years old
- •They will be able to complete the protocol
- •A child will be recruited if the medical evaluation reveals no organic reason for the abdominal pain
排除标准
- •Children who have had past bowel surgery;
- •A child with documented GI disorders (e.g., Crohn's disease);
- •A child with a serious chronic medical condition (e.g., diabetes);
- •A child with a weight and/or height < 2 SD for age;
- •Children with chronic conditions with GI symptoms (e.g., cystic fibrosis);
- •Children with autism spectrum disorder, significant developmental delay, psychosis, depression, or a history of bipolar disorder;
- •Children who have been treated with antibiotics/probiotics within 2 mo. (because of effects on microbiome analysis).
- •Children who speak only Spanish
研究组 & 干预措施
180 mg
180 mg of peppermint oil
干预措施: Peppermint oil (Drug)
360 mg
360 mg of peppermint oil
干预措施: Peppermint oil (Drug)
540 mg
540 mg of peppermint oil
干预措施: Peppermint oil (Drug)
结局指标
主要结局
Pharmacokinetics
时间窗: 24 hours
Area under the curve
次要结局
- Contractility(Prior to and during peppermint oil treatment)
- Gut Microbiome Composition(Prior to and during peppermint oil treatment)
- Motility(Prior to and during peppermint oil treatment)
研究者
Robert Shulman, M.D.
Professor
Baylor College of Medicine