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

• Status: Completed
• Trial end date: 2019-03-28
• Target enrollment: 0
• Participant gender: All

Summary

Aim 1 - Determine the PKD of PMO (menthol) in children with functional abdominal pain (FAP) (n=30). Aim 2 - Determine effect of PMO administration on gut microbiome composition and contractile activity/gut transit rate.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Robert Shulman, M.D.
• Treatments: Peppermint oil

Criteria

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