Status:
COMPLETED
Peppermint Oil Pharmacokinetics/Dynamics and Novel Biological Signatures in Children With Functional Abdominal Pain
Lead Sponsor:
Robert Shulman, M.D.
Conditions:
Abdominal Pain
Eligibility:
All Genders
7-12 years
Phase:
PHASE1
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 d...
Detailed 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 ge...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 28 2019
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03295747
Start Date
October 15 2017
End Date
March 28 2019
Last Update
April 6 2022
Active Locations (1)
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1
Texas Children's Hospital
Houston, Texas, United States, 77030