Ignite Creation Date:
2024-05-06 @ 12:54 AM
Last Modification Date:
2024-10-26 @ 10:56 AM
Study NCT ID:
NCT01684319
Status:
COMPLETED
Last Update Posted:
2014-01-06
First Post:
2012-09-10
Brief Title:
Milk-induced Gastrointestinal Symptoms in Infants
Sponsor:
University Hospital Geneva
Organization:
University Hospital Geneva
Study Overview
Official Title:
Prospective Randomized Double Blind and Placebo Controlled Study With the Aim to Establish the Role of Milk Proteins in Gastrointestinal Diseases GERD Constipation and Colics of Young Infants and to Determine the Diagnostic Value of Immunological Tests in These Pathologies
Status:
COMPLETED
Status Verified Date:
2014-01
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:
Various digestive manifestations are common in infants less than 6 months and have a significant impact on morbidity and quality of life of the family In a prospective study on more than 2800 Italian infants followed by 0-6 months of life it was determined that 55 of these children had gastrointestinal symptoms such as regurgitation 23 colics 20 constipation 17 or poor weight gain 15 However these symptoms are not very accurate and their cause is often difficult to determine Frequently the pediatrician will exclude cows milk protein in infant feeding but without a clear etiological diagnosis was asked This measure causes significant additional costs through the use of extensively hydrolyzed milk specifically for children and involves an elimination diet of all foods containing cows milk sometimes for several years This can negatively influence the growth of the child
If the involvement of milk in these pathologies is suggested by some early studies 35 for colics 68 in constipation 42 in gastroesophageal reflux it is unclear in the current state of knowledge if these gastrointestinal symptoms are actually due to an allergy to milk Moreover there is no validated diagnostic test for non-IgE-mediated gut allergy However various tests have proven their effectiveness in the investigation of non IgE-mediated allergy eg LAT patch tests and will be used in this study
If the involvement of milk in these pathologies is suggested by some early studies 35 for colics 68 in constipation 42 in gastroesophageal reflux it is unclear in the current state of knowledge if these gastrointestinal symptoms are actually due to an allergy to milk Moreover there is no validated diagnostic test for non-IgE-mediated gut allergy However various tests have proven their effectiveness in the investigation of non IgE-mediated allergy eg LAT patch tests and will be used in this study
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