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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

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
Abdominal Pain 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abdominal Pain

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 Name: 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 Name: menthol




Primary Outcome Measures :
  1. Pharmacokinetics of peppermint oil [ Time Frame: 2 weeks ]
    Area under the curve

  2. 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.

  3. Gut transit time [ Time Frame: 2 weeks ]
    Gut transit time as a consequence of the administration of peppermint oil at the two doses given.

  4. Gut contractility [ Time Frame: 2 weeks ]
    Gut contractility as a consequence of the administration of peppermint oil at the two doses given.



Information from the National Library of Medicine

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04497870


Contacts
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Contact: Heather Charron 7137980381 Heather.Charron@bcm.edu

Locations
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United States, Texas
Children's Nutrition Research Center Recruiting
Houston, Texas, United States, 77030
Contact: Heather Charron    713-798-0381    Heather.Charron@bcm.edu   
Sponsors and Collaborators
Baylor College of Medicine
Investigators
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Principal Investigator: Robert J Shulman, MD Baylor College of Medicine
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Responsible Party: Robert Shulman, M.D., Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT04497870    
Other Study ID Numbers: R33AT009101 ( U.S. NIH Grant/Contract )
First Posted: August 4, 2020    Key Record Dates
Last Update Posted: September 22, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Abdominal Pain
Pain
Neurologic Manifestations
Signs and Symptoms, Digestive
Peppermint oil
Menthol
Antipruritics
Dermatologic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Parasympatholytics