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Peppermint Oil Pharmacokinetics/Dynamics

Sponsor
Baylor College of Medicine (Other)
Overall Status
Recruiting
CT.gov ID
NCT04497870
Collaborator
(none)
42
Enrollment
1
Location
2
Arms
31.7
Anticipated Duration (Months)
1.3
Patients Per Site Per Month

Study Details

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:

  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)

Condition or Disease Intervention/Treatment Phase
  • Drug: Peppermint oil
 Phase 1

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
42 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Peppermint Oil Pharmacokinetics/Dynamics and Novel Biological Signatures in Children With Functional Abdominal Pain
Actual Study Start Date :
Jul 9, 2020
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 540 mg

Peppermint oil at a dose of 180 mg thrice daily orally

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

    		•
    Experimental: 900 mg

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

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pharmacokinetics of peppermint oil [2 weeks]

      Area under the curve

    2. Gut Microbiome composition [2 weeks]

      Gut microbiome composition as determined by 16S sequencing as a consequence of the administration of peppermint oil at the two doses given.

    3. Gut transit time [2 weeks]

      Gut transit time as a consequence of the administration of peppermint oil at the two doses given.

    4. Gut contractility [2 weeks]

      Gut contractility as a consequence of the administration of peppermint oil at the two doses given.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    7 Years to 12 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Children's Nutrition Research Center Houston Texas United States 77030

    Sponsors and Collaborators

    • Baylor College of Medicine

    Investigators

    • Principal Investigator: Robert J Shulman, MD, Baylor College of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Robert Shulman, M.D., Professor, Baylor College of Medicine
    ClinicalTrials.gov Identifier:
    NCT04497870
    Other Study ID Numbers:
    • H-40351
    First Posted:
    Aug 4, 2020
    Last Update Posted:
    Nov 15, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Abdominal Pain
    Peppermint oil
    Menthol

    Study Results

    No Results Posted as of Nov 15, 2021