Gastrointestinal Symptoms in Young Infants Clinical Trial
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.
| Verified date | January 2014 |
| Source | University Hospital, Geneva |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Switzerland: Ethikkommission |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 120 |
| Est. completion date | November 2013 |
| Est. primary completion date | August 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A to 6 Months |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | Département de l'enfant et de l'adolesent - Hôpitaux Universitaires de Genève | Genève | GE |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Geneva |
Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Milk allergy in gastrointestinal diseases in young infants | Establish the role of milk proteins in gastrointestinal diseases in young infants | 10 weeks | No |
| Secondary | Diagnostic tests | Determine the diagnostic value of immunological tests in these pathologies | 10 weeks | No |