Peppermint Oil Pharmacokinetics/Dynamics

Withdrawn before enrolling · Phase 1

Conditions studied: Abdominal Pain

In brief

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)

Key facts

Study ID

NCT04497870

Run by

Baylor College of Medicine

People needed

0

Starts

2020-07-09

Expected to finish

2023-09-14

Last updated by the study team

2023-12-11

Who can join

Age: 7 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Children ages 7-12 years who are able to assent to the procedures
• Able to complete the diaries which have been validated for use in this age range
• The history and medical evaluation reveal no organic reason for the abdominal pain
• The child has abdominal pain that meets the definition of FAP according to pediatric Rome IV
• Ability to understand study procedures and to comply with them for the entire length of the study
• Childrens' body weights will not vary by more than 10-15 kg (so that dose per kg is comparable within the two dosing groups)

You may not qualify if…

• Past bowel surgery
• Documented GI disorders (e.g., Crohn's disease)
• A serious chronic medical condition (e.g., diabetes)
• A weight and/or height < 2 SD for age
• Chronic conditions with GI symptoms (e.g., cystic fibrosis)
• Autism spectrum disorder, significant developmental delay, psychosis, depression, or a history of bipolar disorder
• Antibiotic/probiotic treatment within 2 mo.
• Allergy/sensitivity to PMO or its ingredients
• Inability to swallow the PMO capsule or the SmartPill®
• Inability to speak English - testing materials are available only in this language
• Unable to discontinue laxative, prokinetic, or neuromodulator from 3 wk prior to Visit 1 through the end of the study

Where it is running

• Children's Nutrition Research Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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