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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-15

Study Completion Date

2019-03-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Peppermint Oil Pharmacokinetics/Dynamics

NCT04497870

Abdominal Pain

WITHDRAWN PHASE1

The Effect of Pain Medication in Children With Acute Abdominal Pain and Its Implication Over the Surgeon's Decision

NCT00839787

Abdominal Pain

WITHDRAWN NA

Abdominal Pain Disorders Functional in Children: Impact of Hypno-analgesia on the Autonomic Balance

NCT02830698

Child Abdominal Pain

TERMINATED

Oral Ketamine for Control of Chronic Pain in Children

NCT01369680

Chronic Pain

COMPLETED PHASE1

The Pharmacokinetics of Ketorolac Tromethamine Administered Intranasally (IN) for Postoperative Pain in Children Aged 12 Through 17 Years

NCT01363076

Postoperative Pain

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Abdominal Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

180 mg

180 mg of peppermint oil

Group Type EXPERIMENTAL

Peppermint oil

Intervention Type DRUG

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

360 mg

360 mg of peppermint oil

Group Type EXPERIMENTAL

Peppermint oil

Intervention Type DRUG

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

540 mg

540 mg of peppermint oil

Group Type EXPERIMENTAL

Peppermint oil

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Peppermint oil

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Enteric coated peppermint oil capsules

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

7 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No