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Peppermint Oil Pharmacokinetics/Dynamics

NCT04497870 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2023-12-11

No results posted yet for this study

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)

Conditions

Interventions

DRUG

Peppermint oil

Administration of peppermint oil at one of two daily doses.

Sponsors & Collaborators

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • Robert J Shulman, MD · Baylor College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-09
Primary Completion
2023-09-14
Completion
2023-09-14
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04497870 on ClinicalTrials.gov