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Milk-induced Gastrointestinal Symptoms in Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01684319
Recruitment Status : Completed
First Posted : September 12, 2012
Last Update Posted : January 6, 2014
Information provided by (Responsible Party):
Philippe Eigenmann, 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.

Condition or disease Intervention/treatment Phase
Gastrointestinal Symptoms in Young Infants Dietary Supplement: Formula milk free of cow's milk protein Dietary Supplement: Placebo Not Applicable

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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
Actual Primary Completion Date : August 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation
Drug Information available for: Casein

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

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

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

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

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 identifier (NCT number): NCT01684319

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Département de l'enfant et de l'adolesent - Hôpitaux Universitaires de Genève
Genève, GE, Switzerland, 1211
Sponsors and Collaborators
University Hospital, Geneva
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Study Director: Philippe A Eigenmann, MD Hôpitaux Unversitaire de Genève
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Responsible Party: Philippe Eigenmann, Professor, University Hospital, Geneva Identifier: NCT01684319    
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:
Gastroeosphageal reflux
Additional relevant MeSH terms:
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Signs and Symptoms, Digestive
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action