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Milk-induced Gastrointestinal Symptoms in Infants

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ClinicalTrials.gov Identifier: NCT01684319
Recruitment Status : Completed
First Posted : September 12, 2012
Last Update Posted : January 6, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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.
Study Start Date : August 2012
Primary Completion Date : August 2013
Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Milk allergy in gastrointestinal diseases in young infants [ Time Frame: 10 weeks ]
    Establish the role of milk proteins in gastrointestinal diseases in young infants


Secondary Outcome Measures :
  1. Diagnostic tests [ Time Frame: 10 weeks ]
    Determine the diagnostic value of immunological tests in these pathologies


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Philippe Eigenmann, Professor, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT01684319     History of Changes
Other Study ID Numbers: 11-202 (MATPED 11-047)
First Posted: September 12, 2012    Key Record Dates
Last Update Posted: January 6, 2014
Last Verified: January 2014

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

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