Milk-induced Gastrointestinal Symptoms in Infants

January 3, 2014 updated by: Philippe Eigenmann, University Hospital, Geneva

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • GE
      • Genève, GE, Switzerland, 1211
        • Département de l'enfant et de l'adolesent - Hôpitaux Universitaires de Genève

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 6 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Milk allergy in gastrointestinal diseases in young infants
Time Frame: 10 weeks
Establish the role of milk proteins in gastrointestinal diseases in young infants
10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic tests
Time Frame: 10 weeks
Determine the diagnostic value of immunological tests in these pathologies
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Geneva

Investigators

  • Study Director: Philippe A Eigenmann, MD, Hôpitaux Unversitaire de Genève

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

September 10, 2012

First Submitted That Met QC Criteria

September 11, 2012

First Posted (Estimate)

September 12, 2012

Study Record Updates

Last Update Posted (Estimate)

January 6, 2014

Last Update Submitted That Met QC Criteria

January 3, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-202 (MATPED 11-047)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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