Peppermint Oil Pharmacokinetics/Dynamics

Abdominal Pain Clinical Trial

Official title:

Peppermint Oil Pharmacokinetics/Dynamics and Novel Biological Signatures in Children With Functional Abdominal Pain

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04497870
• Other study ID #: H-40351
• Status: Withdrawn
• Phase: Phase 1
• Start date: July 9, 2020
• Est. completion date: September 14, 2023

Study information

• Verified date: December 2023
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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 (1.67-fold the median dose). Following the single-dose PK study, a PD study will be carried out wherein the subjects will receive their assigned dose of PMO for 7 days. At baseline (before the PK study) and after the PK study (i.e., during the PD study), subjects will keep a pain and stooling diary, collect stool for microbiome analysis, and swallow a SmartPill to measure gut motility and transit time. At baseline only, anxiety, depression, somatization will be measured. During the PD study, any side effects will be recorded.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 14, 2023
• Est. primary completion date: September 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Pain

Intervention

Drug:
• Peppermint oil
Administration of peppermint oil at one of two daily doses.

Locations

Country	Name	City	State
United States	Children's Nutrition Research Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics of peppermint oil	Area under the curve	2 weeks
Primary	Gut Microbiome composition	Gut microbiome composition as determined by 16S sequencing as a consequence of the administration of peppermint oil at the two doses given.	2 weeks
Primary	Gut transit time	Gut transit time as a consequence of the administration of peppermint oil at the two doses given.	2 weeks
Primary	Gut contractility	Gut contractility as a consequence of the administration of peppermint oil at the two doses given.	2 weeks