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Peppermint Oil Pharmacokinetics/Dynamics

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ClinicalTrials.gov Identifier: NCT04497870
Recruitment Status : Recruiting
First Posted : August 4, 2020
Last Update Posted : September 22, 2020
Sponsor:
Information provided by (Responsible Party):
Robert Shulman, M.D., Baylor College of Medicine

Tracking Information
First Submitted Date  ICMJE June 22, 2020
First Posted Date  ICMJE August 4, 2020
Last Update Posted Date September 22, 2020
Estimated Study Start Date  ICMJE September 2020
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 3, 2020)
  • Pharmacokinetics of peppermint oil [ Time Frame: 2 weeks ]
    Area under the curve
  • Gut Microbiome composition [ Time Frame: 2 weeks ]
    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 [ Time Frame: 2 weeks ]
    Gut transit time as a consequence of the administration of peppermint oil at the two doses given.
  • Gut contractility [ Time Frame: 2 weeks ]
    Gut contractility as a consequence of the administration of peppermint oil at the two doses given.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Peppermint Oil Pharmacokinetics/Dynamics
Official Title  ICMJE Peppermint Oil Pharmacokinetics/Dynamics and Novel Biological Signatures in Children With Functional Abdominal Pain
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)
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Abdominal Pain
Intervention  ICMJE Drug: Peppermint oil
Administration of peppermint oil at one of two daily doses.
Other Name: menthol
Study Arms  ICMJE
  • Active Comparator: 540 mg
    Peppermint oil at a dose of 180 mg thrice daily orally
    Intervention: Drug: Peppermint oil
  • Experimental: 900 mg
    Peppermint oil at a dose of 180 mg five times daily orally
    Intervention: Drug: Peppermint oil
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 3, 2020)
42
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2023
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Heather Charron 7137980381 Heather.Charron@bcm.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04497870
Other Study ID Numbers  ICMJE R33AT009101( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Robert Shulman, M.D., Baylor College of Medicine
Study Sponsor  ICMJE Baylor College of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Robert J Shulman, MD Baylor College of Medicine
PRS Account Baylor College of Medicine
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP