Status:
WITHDRAWN
Peppermint Oil Pharmacokinetics/Dynamics
Lead Sponsor:
Baylor College of Medicine
Conditions:
Abdominal Pain
Eligibility:
All Genders
7-12 years
Phase:
PHASE1
Brief 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) ...
Detailed Description
An initial single-dose PK study will be carried out. Forty-two children (n=21 per dose) will be randomized to receive approximately 10.9 mg·kg-1·d-1 of PMO or to receive approximately 18.2 mg·kg-1·d-1...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 14 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04497870
Start Date
July 9 2020
End Date
September 14 2023
Last Update
December 11 2023
Active Locations (1)
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1
Children's Nutrition Research Center
Houston, Texas, United States, 77030