Milk-induced Gastrointestinal Symptoms in Infants

Not Applicable

Completed

• Conditions: Gastrointestinal Symptoms in Young Infants
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Formula milk free of cow's milk protein

• Registration Number: NCT01684319
• Lead Sponsor: University Hospital, Geneva

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 cow's 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 cow's 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-09-10
• Study First Submitted QC: 2012-09-11
• Study First Posted: 2012-09-12
• Primary Completion: 2013-08
• Study Completion: 2013-11
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-03
• Last Update Posted: 2014-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Infants 0-6 month old with at least one of the following symptoms : constipation, gastroesophageal reflux, colics

Exclusion Criteria

• Prematurity
• exclusive breastfeeding
• Other cause for symptoms

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Infant formula milk	Placebo	Infant formula milk adapted to age of infant
Formula milk free of milk proteins	Formula milk free of cow's milk protein	Milk-free formula milk adapted to age of infant

Primary Outcome Measures

Name	Time	Method
Milk allergy in gastrointestinal diseases in young infants	10 weeks	Establish the role of milk proteins in gastrointestinal diseases in young infants

Secondary Outcome Measures

Name	Time	Method
Diagnostic tests	10 weeks	Determine the diagnostic value of immunological tests in these pathologies

Trial Locations

Locations (1)

Département de l'enfant et de l'adolesent - Hôpitaux Universitaires de Genève; 🇨🇭 Genève, GE, Switzerland