drugset / Trial / NCT03295747
Peppermint Oil Pharmacokinetics/Dynamics and Novel Biological Signatures in Children With Functional Abdominal Pain
RandomizedParallel-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2017-10-15
- Primary completion
- 2019-03-28
- Completion
- 2019-03-28
Publications
- Results Shulman RJ, Chumpitazi BP, Abdel-Rahman SM, Garg U, Musaad S, Kearns GL. Randomised trial: Peppermint oil (menthol) pharmacokinetics in children and effects on gut motility in children with functional abdominal pain. Br J Clin Pharmacol. 2022 Mar;88(3):1321-1333. doi: 10.1111/bcp.15076. Epub 2021 Oct 19.
- Results Thapa S, Luna RA, Chumpitazi BP, Oezguen N, Abdel-Rahman SM, Garg U, Musaad S, Versalovic J, Kearns GL, Shulman RJ. Peppermint oil effects on the gut microbiome in children with functional abdominal pain. Clin Transl Sci. 2022 Apr;15(4):1036-1049. doi: 10.1111/cts.13224. Epub 2022 Jan 20.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Peppermint oil | Other / unclassified | 180 mg | Oral |
| Subject | Peppermint oil | Other / unclassified | 360 mg | Oral |
| Subject | Peppermint oil | Other / unclassified | 540 mg | Oral |
Indications
No indication recorded.