Peppermint Oil Pharmacokinetics/Dynamics | NCT04497870

Studies
Peppermint Oil Pharmacokinetics/Dynamics

NCT04497870

Sponsor

Baylor College of Medicine

Status

Withdrawn

Last Update Posted

Dec 11, 2023Actual

Enrollment

0Actual

Phase

Phase 1

Conditions

Abdominal Pain

Interventions

Peppermint oil

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

This study was superseded by NCT03295747

Expanded Access Info

Start Date

Jul 9, 2020Actual

Primary Completion Date

Sep 14, 2023Actual

Completion Date

Sep 14, 2023Actual

First Submitted Date

Jun 22, 2020

First Submission Date that Met QC Criteria

Aug 3, 2020

First Posted Date

Aug 4, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 7, 2023

Last Update Posted Date

Dec 11, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

Microbiome composition (16S RNA sequencing)
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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Peppermint oil	Drug	Administration of peppermint oil at one of two daily doses.	540 mg 900 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

7 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Robert J Shulman, MD	Baylor College of Medicine	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Children's Nutrition Research Center		Houston	Texas	77030	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015746	Abdominal Pain

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Term
D003511	Cyclohexanols
D000441	Hexanols
D005233	Fatty Alcohols
D000438	Alcohols
D009930

ID	Term
C015424	peppermint oil
D008610	Menthol