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

Abdominal Pain Clinical Trial

— PMO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03295747
• Other study ID #: R21AT009101-01
• Status: Completed
• Phase: Phase 1
• Start date: October 15, 2017
• Est. completion date: March 28, 2019

Study information

• Verified date: April 2022
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 28, 2019
• Est. primary completion date: March 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Pain

Intervention

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

Locations

Country	Name	City	State
United States	Texas Children's Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Robert Shulman, M.D.

Country where clinical trial is conducted

United States, 

References & 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):13 — View Citation

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 Jan 20. doi: 10.1111/cts.132 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics	Area under the curve	24 hours
Secondary	Contractility	Number and amplitude of gut contractions as measured by SmartPill	Prior to and during peppermint oil treatment
Secondary	Gut Microbiome Composition	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.	Prior to and during peppermint oil treatment
Secondary	Motility	Gut transit time as measured by SmartPill	Prior to and during peppermint oil treatment