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

April 1, 2022 updated by: Robert Shulman, M.D.

Aim 1 - Determine the pharmacokinetics of PMO (menthol) of three different doses in children with functional abdominal pain (FAP) (n=30).

Aim 2 - Determine pharmacodynamic effect of three different doses of PMO on gut microbiome composition and contractile activity/gut transit rate.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Children with functional abdominal pain (FAP) ages 7-12 years (n=30) will be recruited.

The study participants will be admitted to the Children's Nutrition Research Center. A medical history and a general physical examination performed by the investigator or the research nurse. The height, weight, and vital signs (pulse rate, respiratory rate, and seated blood pressure) will be obtained. After application of a topical anesthetic to the site chosen for study-related blood sampling, a cannula will be inserted e to obtain repeated blood samples.

At approximately 0900, subjects will receive one of three doses of PMO as a single oral dose. Immediately prior to administration of the PMO, a blood sample will be obtained to measure total menthol concentration and leukocytes for isolation of DNA for CYP2A6 and UGT2B7 genotyping.

After PMO administration, repeated blood samples will be obtained over 24 hours.

At 2 hours after PMO administration, participants will be given a standardized meal and will eat ad libitum thereafter.

After completion of the final (24 hours) blood samples, vital signs will be reassessed and the venous cannula removed. Parents will receive a follow-up call from the research coordinator to access/evaluate if any adverse effects from dose or blood sampling received at the overnight study visit.

Prior to and after administration of peppermint oil (PMO) for 1 week at the dose defined above, children will undergo measurement of gut microbiome composition and GI motility and transit time. At the time of the stool collection, the child will also keep a 3 day diet history.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Texas Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 12 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Children ages 7-12 years old
  2. They will be able to complete the protocol
  3. A child will be recruited if the medical evaluation reveals no organic reason for the abdominal pain

Exclusion Criteria:

  1. Children who have had past bowel surgery;
  2. A child with documented GI disorders (e.g., Crohn's disease);
  3. A child with a serious chronic medical condition (e.g., diabetes);
  4. A child with a weight and/or height < 2 SD for age;
  5. Children with chronic conditions with GI symptoms (e.g., cystic fibrosis);
  6. Children with autism spectrum disorder, significant developmental delay, psychosis, depression, or a history of bipolar disorder;
  7. Children who have been treated with antibiotics/probiotics within 2 mo. (because of effects on microbiome analysis).
  8. Children who speak only Spanish

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 180 mg
180 mg of peppermint oil
Drug: Peppermint oil
Three doses of peppermint oil will be investigated: 180, 360, 540 mg; i.e. three arms.
Other Names:
  • Enteric coated peppermint oil capsules
EXPERIMENTAL: 360 mg
360 mg of peppermint oil
Drug: Peppermint oil
Three doses of peppermint oil will be investigated: 180, 360, 540 mg; i.e. three arms.
Other Names:
  • Enteric coated peppermint oil capsules
EXPERIMENTAL: 540 mg
540 mg of peppermint oil
Drug: Peppermint oil
Three doses of peppermint oil will be investigated: 180, 360, 540 mg; i.e. three arms.
Other Names:
  • Enteric coated peppermint oil capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics
Time Frame: 24 hours
Area under the curve
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Contractility
Time Frame: Prior to and during peppermint oil treatment
Number and amplitude of gut contractions as measured by SmartPill
Prior to and during peppermint oil treatment
Gut Microbiome Composition
Time Frame: Prior to and during peppermint oil treatment
Microbiome is defined for this study as a statistically significant change from baseline after treatment with PMO, correcting for multiple testing (q value). Such changes may occur with respect to gut microbiome diversity and/or composition (e.g., phylum, family, genera). We anticipate there will be an increased bacterial diversity, as well as increases in the abundance of organisms associated with a healthy microbiome, in response to PMO administration.
Prior to and during peppermint oil treatment
Motility
Time Frame: Prior to and during peppermint oil treatment
Gut transit time as measured by SmartPill
Prior to and during peppermint oil treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Robert Shulman, M.D.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 15, 2017

Primary Completion (ACTUAL)

March 28, 2019

Study Completion (ACTUAL)

March 28, 2019

Study Registration Dates

First Submitted

December 2, 2016

First Submitted That Met QC Criteria

September 25, 2017

First Posted (ACTUAL)

September 28, 2017

Study Record Updates

Last Update Posted (ACTUAL)

April 6, 2022

Last Update Submitted That Met QC Criteria

April 1, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R21AT009101-01 (NIH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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