Long-term Safety and Efficacy of Prebiotic Enriched Infant Formula

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Effects of the Supplementation With Oligosaccharides on the Prevention of Infections in Infants

Conditions
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Infection, Microbial Colonization, Healthy

Intervention / Treatment
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* Other: Supplemented formula
* Other: Standard formula


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy babies born between 37 - 42 weeks of gestation and with weight appropriate for gestational age (between percentiles 3 and 97) Healthy babies aged between 0 - 4 months of age Babies exclusively fed with an infant formula on enrolment into the study Exclusion Criteria: The presence of an infection at the moment of the recruitment or 1 week before recruitment The presence of important pathologies (intestinal, cardiopathy, mental retardation, etc.) Any other diseases related to the immune system (primary immunodeficiency) Parents not able to comply with the study follow up (according to physician criteria)

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 4 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: supplemented formula<br>Standard formula supplemented with prebiotic inulin-type fructans | Other: Supplemented formula<br>* standard infant formula supplemented with 8 g/L prebiotic inulin-type fructans<br>|
| Placebo Comparator: standard formula<br>Standard Formula not supplemented with prebiotic inulin-type fructans | Other: Standard formula<br>* standard infant formula not supplemented with prebiotic inulin-type fructans<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |