Milk-induced Gastrointestinal Symptoms in Infants

NCT ID: NCT01684319

Last Updated: 2014-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2013-11-30

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.

Conditions

Gastrointestinal Symptoms in Young Infants

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: QUADRUPLE

Study Groups

Infant formula milk

Infant formula milk adapted to age of infant

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Infant formula milk

Formula milk free of milk proteins

Milk-free formula milk adapted to age of infant

Group Type: ACTIVE_COMPARATOR

Formula milk free of cow's milk protein

Intervention Type: DIETARY_SUPPLEMENT

Interventions

Formula milk free of cow's milk protein

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Infant formula milk

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Maximum Eligible Age: 6 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Geneva

OTHER

Sponsor Role: lead

Responsible Party

Philippe Eigenmann

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Philippe A Eigenmann, MD

Role: STUDY_DIRECTOR

Hôpitaux Unversitaire de Genève

Locations

Département de l'enfant et de l'adolesent - Hôpitaux Universitaires de Genève

Geneva, Canton of Geneva, Switzerland

Countries

Switzerland

Other Identifiers

11-202 (MATPED 11-047)

Identifier Type: -

Identifier Source: org_study_id