NCT04497870

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. 1.Microbiome composition (16S RNA sequencing)
  2. 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)

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2020

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2020

Completed
17 days until next milestone

Study Start

First participant enrolled

July 9, 2020

Completed
26 days until next milestone

First Posted

Study publicly available on registry

August 4, 2020

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 14, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2023

Completed
Last Updated

December 11, 2023

Status Verified

December 1, 2023

Enrollment Period

3.2 years

First QC Date

June 22, 2020

Last Update Submit

December 7, 2023

Conditions

Abdominal Pain

Outcome Measures

Primary Outcomes (4)

  • Pharmacokinetics of peppermint oil

    Area under the curve

    2 weeks

  • Gut Microbiome composition

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

    2 weeks

  • Gut transit time

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

    2 weeks

  • Gut contractility

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

    2 weeks

Study Arms (2)

540 mg

ACTIVE COMPARATOR

Peppermint oil at a dose of 180 mg thrice daily orally

Drug: Peppermint oil

900 mg

EXPERIMENTAL

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

Drug: Peppermint oil

Interventions

Peppermint oilDRUG

Administration of peppermint oil at one of two daily doses.

Also known as: menthol
540 mg900 mg

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Nutrition Research Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Abdominal Pain

Interventions

peppermint oilMenthol

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

CyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsCyclohexane MonoterpenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsMonoterpenesTerpenesLipids

Study Officials

  • Robert J Shulman, MD

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 22, 2020

First Posted

August 4, 2020

Study Start

July 9, 2020

Primary Completion

September 14, 2023

Study Completion

September 14, 2023

Last Updated

December 11, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)