Peppermint Oil Pharmacokinetics/Dynamics

• Status: Recruiting
• Trial end date: 2023-03-01
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baylor College of Medicine
• Treatments: Menthol; Peppermint oil

Criteria

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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