Milk-induced Gastrointestinal Symptoms in Infants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Philippe Eigenmann, University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT01684319
First received: September 10, 2012
Last updated: January 3, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Gastrointestinal Symptoms in Young Infants
Dietary Supplement: Formula milk free of cow's milk protein
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
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.

Resource links provided by NLM:


Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • Milk allergy in gastrointestinal diseases in young infants [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    Establish the role of milk proteins in gastrointestinal diseases in young infants


Secondary Outcome Measures:
  • Diagnostic tests [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    Determine the diagnostic value of immunological tests in these pathologies


Enrollment: 120
Study Start Date: August 2012
Study Completion Date: November 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Infant formula milk
Infant formula milk adapted to age of infant
Dietary Supplement: Placebo
Infant formula milk
Active Comparator: Formula milk free of milk proteins
Milk-free formula milk adapted to age of infant
Dietary Supplement: Formula milk free of cow's milk protein

  Eligibility

Ages Eligible for Study:   up to 6 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01684319

Locations
Switzerland
Département de l'enfant et de l'adolesent - Hôpitaux Universitaires de Genève
Genève, GE, Switzerland, 1211
Sponsors and Collaborators
University Hospital, Geneva
Investigators
Study Director: Philippe A Eigenmann, MD Hôpitaux Unversitaire de Genève
  More Information

No publications provided

Responsible Party: Philippe Eigenmann, Professor, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT01684319     History of Changes
Other Study ID Numbers: 11-202 (MATPED 11-047)
Study First Received: September 10, 2012
Last Updated: January 3, 2014
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital, Geneva:
Constipation
Gastroeosphageal reflux
Colics

Additional relevant MeSH terms:
Gastrointestinal Diseases
Signs and Symptoms, Digestive
Digestive System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 20, 2014