drugset / Trial / NCT04497870
Peppermint Oil Pharmacokinetics/Dynamics
RandomizedParallel-groupOpen-labelBasic science
Summary
In children 7-12 years of age with functional abdominal pain (n=42) determine: Aim 1 - To examine and characterize the threshold of the exposure (PK) vs. response (PD) relationship of PMO (menthol) Aim 2 - PD of PMO as assessed by: 1. Microbiome composition (16S RNA sequencing) 2. Transit rate/contractile activity (using the SmartPill®) Aim 3 - Evaluate the potential association between PD response and clinical symptoms (abdominal pain and stooling pattern via validated diary), psychosocial distress (anxiety, depression, somatization), and characterize potential side effects (questionnaire)
Timeline
- Start
- 2020-07-09
- Primary completion
- 2023-09-14
- Completion
- 2023-09-14
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Peppermint oil | Other / unclassified | 540 mg | Oral |
| Subject | Peppermint oil | Other / unclassified | 900 mg | Oral |
Indications
No indication recorded.