Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06617364
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-24
Brief Title:
MSOT for Assessment of Intestinal Transit Time in Lactose Intolerance Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Contrast Enhanced Multispectral Optoacoustic Tomography for Non-invasive Assessment of Intestinal Transit Time in Lactose Intolerance Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study aims to investigate gastrointestinal transit using multispectral optoacoustic tomography MSOT in a prospective diagnostic study involving patients suspected of primary or secondary lactose intolerance These patients exhibit varying clinical symptoms and different results from the hydrogen breath test H2 breath test Lactose intolerance is caused by a deficiency in the enzyme lactase which is responsible for breaking down lactose into glucose and galactose Without this breakdown lactose is fermented by colon bacteria leading to symptoms such as bloating and diarrhea The prevalence of lactose intolerance is increasing especially among children and the current diagnostic gold standard is the hydrogen breath test which while specific has limitations in sensitivity MSOT could fill this diagnostic gap by non-invasively measuring intestinal transit time and providing a more objective assessment of the condition The study will compare MSOT results with H2 breath test outcomes particularly focusing on patients with varying disease durations and activity levels MSOT could improve the sensitivity of lactose intolerance diagnosis differentiate it from other conditions and offer insights into disease management over time
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None