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

NCT03295747 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: R21AT009101-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Pain

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics

  Area under the curve

  24 hours

Secondary Outcomes (3)

• Contractility

  Prior to and during peppermint oil treatment

• Gut Microbiome Composition

  Prior to and during peppermint oil treatment

• Motility

  Prior to and during peppermint oil treatment

Study Arms (3)

180 mg

EXPERIMENTAL

180 mg of peppermint oil

Drug: Peppermint oil

360 mg

EXPERIMENTAL

360 mg of peppermint oil

Drug: Peppermint oil

540 mg

EXPERIMENTAL

540 mg of peppermint oil

Drug: Peppermint oil

Interventions

Peppermint oil DRUG

Three doses of peppermint oil will be investigated: 180, 360, 540 mg; i.e. three arms.

Also known as: Enteric coated peppermint oil capsules

180 mg; 360 mg; 540 mg

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Robert Shulman, M.D.: lead

Study Sites (1)

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Related Publications (2)

• Shulman RJ, Chumpitazi BP, Abdel-Rahman SM, Garg U, Musaad S, Kearns GL. Randomised trial: Peppermint oil (menthol) pharmacokinetics in children and effects on gut motility in children with functional abdominal pain. Br J Clin Pharmacol. 2022 Mar;88(3):1321-1333. doi: 10.1111/bcp.15076. Epub 2021 Oct 19.

  PMID: 34528282 RESULT

• Thapa S, Luna RA, Chumpitazi BP, Oezguen N, Abdel-Rahman SM, Garg U, Musaad S, Versalovic J, Kearns GL, Shulman RJ. Peppermint oil effects on the gut microbiome in children with functional abdominal pain. Clin Transl Sci. 2022 Apr;15(4):1036-1049. doi: 10.1111/cts.13224. Epub 2022 Jan 20.

  PMID: 35048535 RESULT

MeSH Terms

Conditions

Abdominal Pain

Interventions

peppermint oil

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Study Officials

• Shulman J. Shulman, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Participants randomized to one of three prospective arms as reflected by three treatment doses for the duration of the study.

Study Record Dates

• First Submitted: December 2, 2016
• First Posted: September 28, 2017
• Study Start: October 15, 2017
• Primary Completion: March 28, 2019
• Study Completion: March 28, 2019
• Last Updated: April 6, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)