Milk-induced Gastrointestinal Symptoms in Infants
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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. |
- 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
- Diagnostic tests [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]Determine the diagnostic value of immunological tests in these pathologies
| Estimated Enrollment: | 120 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | November 2013 |
| Estimated 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 |
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| Contact: Marcel M Bergmann, MD | +41 79 55 34 787 | marcel.bergmann@hcuge.ch |
| Switzerland | |
| Département de l'enfant et de l'adolesent - Hôpitaux Universitaires de Genève | Recruiting |
| Genève, GE, Switzerland, 1211 | |
| Contact: Marcel M Bergmann, MD +41 79 55 34 787 marcel.bergmann@hcuge.ch | |
| Principal Investigator: Marcel M Bergmann, MD | |
| 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: | September 13, 2012 |
| 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 June 17, 2013