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

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ClinicalTrials.gov Identifier: NCT03295747
Recruitment Status : Completed
First Posted : September 28, 2017
Last Update Posted : April 6, 2022
Sponsor:
Information provided by (Responsible Party):
Robert Shulman, M.D., Baylor College of Medicine

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Abdominal Pain Drug: Peppermint oil Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants randomized to one of three prospective arms as reflected by three treatment doses for the duration of the study.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Peppermint Oil Pharmacokinetics/Dynamics and Novel Biological Signatures in Children With Functional Abdominal Pain
Actual Study Start Date : October 15, 2017
Actual Primary Completion Date : March 28, 2019
Actual Study Completion Date : March 28, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abdominal Pain

Arms and Interventions
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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 Name: 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 Name: 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 Name: Enteric coated peppermint oil capsules


Outcome Measures
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Primary Outcome Measures :
  1. Pharmacokinetics [ Time Frame: 24 hours ]
    Area under the curve


Secondary Outcome Measures :
  1. Contractility [ Time Frame: Prior to and during peppermint oil treatment ]
    Number and amplitude of gut contractions as measured by SmartPill

  2. 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.

  3. Motility [ Time Frame: Prior to and during peppermint oil treatment ]
    Gut transit time as measured by SmartPill


Eligibility Criteria
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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:

  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
Contacts and Locations
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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): NCT03295747


Locations
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United States, Texas
Texas Children's Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Robert Shulman, M.D.
Investigators
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Principal Investigator: Shulman J. Shulman, MD Baylor College of Medicine
  Study Documents (Full-Text)

Documents provided by Robert Shulman, M.D., Baylor College of Medicine:
Study Protocol and Statistical Analysis Plan  [PDF] November 15, 2017

More Information
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Publications of Results:

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Responsible Party: Robert Shulman, M.D., Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT03295747    
Other Study ID Numbers: R21AT009101-01 ( U.S. NIH Grant/Contract )
First Posted: September 28, 2017    Key Record Dates
Last Update Posted: April 6, 2022
Last Verified: April 2022
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
Antiemetics
 Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Parasympatholytics