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Peppermint Oil Pharmacokinetics/Dynamics

Primary Purpose

Abdominal Pain

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Peppermint oil
Sponsored by
Baylor College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Abdominal Pain

Eligibility Criteria

7 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Nutrition Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

540 mg

900 mg

Arm Description

Peppermint oil at a dose of 180 mg thrice daily orally

Peppermint oil at a dose of 180 mg five times daily orally

Outcomes

Primary Outcome Measures

Pharmacokinetics of peppermint oil
Area under the curve
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.
Gut transit time
Gut transit time as a consequence of the administration of peppermint oil at the two doses given.
Gut contractility
Gut contractility as a consequence of the administration of peppermint oil at the two doses given.

Secondary Outcome Measures

Full Information

First Posted
June 22, 2020
Last Updated
February 13, 2023
Sponsor
Baylor College of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04497870
Brief Title
Peppermint Oil Pharmacokinetics/Dynamics
Official Title
Peppermint Oil Pharmacokinetics/Dynamics and Novel Biological Signatures in Children With Functional Abdominal Pain
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Withdrawn
Why Stopped
This study was superseded by NCT03295747
Study Start Date
July 9, 2020 (Actual)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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) Aim 2 - PD of PMO as assessed by: Microbiome composition (16S RNA sequencing) 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)
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 (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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Pain

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
540 mg
Arm Type
Active Comparator
Arm Description
Peppermint oil at a dose of 180 mg thrice daily orally
Arm Title
900 mg
Arm Type
Experimental
Arm Description
Peppermint oil at a dose of 180 mg five times daily orally
Intervention Type
Drug
Intervention Name(s)
Peppermint oil
Other Intervention Name(s)
menthol
Intervention Description
Administration of peppermint oil at one of two daily doses.
Primary Outcome Measure Information:
Title
Pharmacokinetics of peppermint oil
Description
Area under the curve
Time Frame
2 weeks
Title
Gut Microbiome composition
Description
Gut microbiome composition as determined by 16S sequencing as a consequence of the administration of peppermint oil at the two doses given.
Time Frame
2 weeks
Title
Gut transit time
Description
Gut transit time as a consequence of the administration of peppermint oil at the two doses given.
Time Frame
2 weeks
Title
Gut contractility
Description
Gut contractility as a consequence of the administration of peppermint oil at the two doses given.
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert J Shulman, MD
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Nutrition Research Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Peppermint Oil Pharmacokinetics/Dynamics

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