Ignite Creation Date:
2024-05-06 @ 3:00 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04497870
Status:
WITHDRAWN
Last Update Posted:
2023-12-11
First Post:
2020-06-22
Brief Title:
Peppermint Oil PharmacokineticsDynamics
Sponsor:
Baylor College of Medicine
Organization:
Baylor College of Medicine
Study Overview
Official Title:
Peppermint Oil PharmacokineticsDynamics and Novel Biological Signatures in Children With Functional Abdominal Pain
Status:
WITHDRAWN
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
This study was superseded by NCT03295747
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In children 7-12 years of age with functional abdominal pain n42 determine
Aim 1 - To examine and characterize the threshold of the exposure PK vs response PD relationship of PMO menthol
Aim 2 - PD of PMO as assessed by
1 Microbiome composition 16S RNA sequencing
2 Transit ratecontractile activity using the SmartPill Aim 3 - Evaluate the potential association between PD response and clinical symptoms abdominal pain and stooling pattern via validated diary psychosocial distress anxiety depression somatization and characterize potential side effects questionnaire
Aim 1 - To examine and characterize the threshold of the exposure PK vs response PD relationship of PMO menthol
Aim 2 - PD of PMO as assessed by
1 Microbiome composition 16S RNA sequencing
2 Transit ratecontractile activity using the SmartPill Aim 3 - Evaluate the potential association between PD response and clinical symptoms abdominal pain and stooling pattern via validated diary psychosocial distress anxiety depression somatization and characterize potential side effects questionnaire
Detailed Description:
An initial single-dose PK study will be carried out Forty-two children n21 per dose will be randomized to receive approximately 109 mgkg-1d-1 of PMO or to receive approximately 182 mgkg-1d-1 167-fold the median dose
Following the single-dose PK study a PD study will be carried out wherein the subjects will receive their assigned dose of PMO for 7 days
At baseline before the PK study and after the PK study ie during the PD study subjects will keep a pain and stooling diary collect stool for microbiome analysis and swallow a SmartPill to measure gut motility and transit time At baseline only anxiety depression somatization will be measured During the PD study any side effects will be recorded
Following the single-dose PK study a PD study will be carried out wherein the subjects will receive their assigned dose of PMO for 7 days
At baseline before the PK study and after the PK study ie during the PD study subjects will keep a pain and stooling diary collect stool for microbiome analysis and swallow a SmartPill to measure gut motility and transit time At baseline only anxiety depression somatization will be measured During the PD study any side effects will be recorded
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None