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| Name | Class |
|---|---|
| Laboratorios Ordesa | INDUSTRY |
| European Union | OTHER |
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The primary objective of the present study was to evaluate the effects of long-term supplementation of an infant formula supplemented with prebiotic inulin-type oligosaccharides on immunological-health related outcomes.
The study primarily aimed to evaluate the effects of long-term supplementation of an infant formula with a mixture of short and long chain inulin-type oligosaccharides on immunological-health related outcomes, as well as on gastrointestinal function and well-being in infants during the first year of life. Effects on infant growth, tolerance and on the composition of fecal microbiota were further objectives of this study. The study was conducted as a multicenter, randomised, double-blind, placebo-controlled study in healthy term infants. The two groups of the study are product group (standard infant formula supplemented with inulin-type fructans) and control group (non-supplemented standard infant formula).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| supplemented formula | Experimental | Standard formula supplemented with prebiotic inulin-type fructans |
|
| standard formula | Placebo Comparator | Standard Formula not supplemented with prebiotic inulin-type fructans |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supplemented formula | Other | standard infant formula supplemented with 8 g/L prebiotic inulin-type fructans |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of infections during first year of life | measured through presence of fever, and number and duration of infectious episodes | until infant reaches age of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Stool frequency | Number of depositions per day assessed by parenteral reporting (parent's diary collected during first week of each study month throughout all study period) | until infant reaches age of 1 year |
| Stool consistency |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ZNA Koningin Paola Kinderziekenhuis | Antwerp | Belgium | ||||
| Universitair Ziekenhuis |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Rodriguez-Palmero, M.; Campoy, C.; Urraca, O.; Alonso, J.; Maldonado, J.; Varea, V.; Palencia, J.; Veereman-Wauters, G.; Neumer, F.; Rivero, M.; Vandenplas, Y. Effects of long-term supplementation with a mixture of short and long chain inulin-type oligosaccharides (2013), Annals of Nutrition and Metabolism, suppl. 1, (63), 1-1960. |
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| ID | Term |
|---|---|
| D007239 | Infections |
| D003141 | Communicable Diseases |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Standard formula | Other | standard infant formula not supplemented with prebiotic inulin-type fructans |
|
Assessed via 1-3 scale with pictograms (1=hard, 2=soft/formed, 3=liquid/semi-liquid), by parenteral reporting (parent's diary collected during first week of each study month throughout all study period)
| until infant reaches age of 1 year |
| Digestive tolerance | Number of vomiting and regurgitation episodes per day and presence of excessive flatulence and infantile colic, assessed by parenteral reporting (parent's diary collected during first week of each study month throughout all study period) | until infant reaches age of 1 year |
| Growth | Calculation of z-scores of weight-for-age and length-for-age according to the World Health Organisation (WHO) standards using WHO software (WHO Antro software). | until infant reaches age of 1 year |
| Body weight | Assessment of weight (kg) of the nude infant via calibrated electronic scales at all study visits. | until infant reaches age of 1 year |
| Body height | Assessment of height (cm) in supine position by using a standard measuring board at all study visits. | until infant reaches age of 1 year |
| Head circumference | Assessment of head circumference (cm) using a non-extendable insertion tape at all study visits. | until infant reaches age of 1 year |
| Sleeping habits | Assessment of total hours slept and total hours of nocturnal sleeping per day (min), by parenteral reporting (parent's diary collected during first week of each study month throughout all study period). | until infant reaches age of 1 year |
| Crying episodes | Assessment of crying episodes (min), by parenteral reporting (parent's diary collected during first week of each study month throughout all study period). | until infant reaches age of 1 year |
| Effect on fecal microbiota composition | Quantification of dominant bacterial groups | until infant reaches age of 1 year |
| Effect on development of allergy | Presence of clinical symptoms compatible with food allergies, atopic dermatitis, exanthema | until infant reaches age of 1 year |
| Effect on immunology markers in feces | secretory immunoglobulin A, calprotectin level | until infant reaches age of 1 year |
| Brussels |
| Belgium |
| CAP Llefià | Barcelona | Spain |
| Hospital de Nens | Barcelona | Spain |
| Hospital Sant Joan de Deu | Barcelona | Spain |
| University Hospital Vall d'Hebron | Barcelona | Spain |
| Hospital San Cecilio | Granada | Spain |
| Equipo Pediátrico San Francisco | Madrid | Spain |