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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infant formula milk | Placebo Comparator | Infant formula milk adapted to age of infant |
|
| Formula milk free of milk proteins | Active Comparator | Milk-free formula milk adapted to age of infant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Formula milk free of cow's milk protein | Dietary Supplement |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Milk allergy in gastrointestinal diseases in young infants | Establish the role of milk proteins in gastrointestinal diseases in young infants | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic tests | Determine the diagnostic value of immunological tests in these pathologies | 10 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philippe A Eigenmann, MD | Hôpitaux Unversitaire de Genève | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Département de l'enfant et de l'adolesent - Hôpitaux Universitaires de Genève | Geneva | Canton of Geneva | 1211 | Switzerland |
| Type | Date | Date Unknown |
|---|---|---|
| Release | May 18, 2022 | |
| Reset | Feb 16, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 18, 2022 | Feb 16, 2023 |
| ID | Term |
|---|---|
| D003248 | Constipation |
| D003085 | Colic |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007232 | Infant, Newborn, Diseases |
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| Dietary Supplement |
Infant formula milk |
|
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |