Ignite Creation Date:
2025-12-24 @ 5:48 PM
Ignite Modification Date:
2025-12-29 @ 7:22 PM
Study NCT ID:
NCT06789068
Status:
COMPLETED
Last Update Posted:
2025-01-23
First Post:
2025-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lactose Intolerance in Infants With Gastrointestinal Disturbances
Sponsor:
Ain Shams University
Organization:
Study Overview
Official Title:
Lactose Intolerance in Infants With Gastrointestinal Disturbances
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study enrolled thirty infants who presented by GIT symptoms and their CoMiSS was ≥ 12. The patients were assessed upon presentation, after 2 weeks of receiving lactose free diet regimen and 2 weeks after rechallenging them with lactose. Assessments of infants included anthropometric measurements, CoMiSS estimation, Neonatal/Infant Pain Scale (NIPS) and pediatric quality of life assessment (Peds QL). The study aims to detect the frequency of infants with LI with positive Cow's Milk-related Symptom Score (CoMiSS) (which could lead to misdiagnosis as CMPA) and validate of this score to be used as a screening tool for LI in infants.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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?: