Methods criteria for considering studies for this review




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títuloMethods criteria for considering studies for this review
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fecha de publicación27.11.2015
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ONLINE SUPPLEMENTARY MATERIAL
SUPPLEMENTATION OF INFANT FORMULA

WITH PROBIOTICS AND/OR PREBIOTICS: A SYSTEMATIC REVIEW AND COMMENT BY THE ESPGHAN COMMITTEE ON NUTRITION
ESPGHAN Committee on Nutrition: §Christian Braegger; §3Anna Chmielewska, ¤Tamas Decsi; *Sanja Kolacek; ‡ ‡ Walter Mihatsch; * * Luis Moreno; §3 Małgorzata Pieścik; || ||John Puntis; ^1Raanan Shamir; § §Hania Szajewska; # 2Dominique Turck; ¢Johannes van Goudoever.
§University Children’s Hospital, Zurich, Switzerland; ¤ Department of Paediatrics, University of Pecs, Hungary; * University Children’s Hospital Zagreb, Croatia; * *Escuela Universitaria de Ciencias de la Salud, Universidad de Zaragoza, Spain; || || Leeds General Infirmary, United Kingdom; ^Schneider Children's Medical Center of Israel, Sackler Faculty of Medicine, Tel-Aviv University, Israel; §§The Medical University of Warsaw, Poland; Department of Paediatrics # Jeanne de Flandre Children’s Hospital, Lille University Faculty of Medicine, France; ¢ Erasmus MC/Sophia Children's Hospital, Rotterdam, The Netherlands
1Committee Chair, 2Committee Secretary, 3Guest.
Short title: Supplementation of infant formula with probiotics and/or prebiotics


METHODS

Criteria for considering studies for this review


Types of studies

All relevant randomised controlled trials (RCT) and quasi-RCT (defined as studies in which the participants are allocated to different interventions using methods that are not random; for example, allocation may be based on the person's date of birth), or their systematic reviews/meta-analyses were considered for inclusion. Studies of cross-over design were excluded.
Types of participants

Participants had to be healthy term infants. Studies related to preterm infants were excluded (this topic will be covered in a separate report by the Committee).
Types of interventions

Studies that compared use of infant formula (i.e., foodstuffs intended for particular nutritional use by infants during the first months of life and satisfying by themselves the nutritional requirements of such infants until the introduction of appropriate complementary feeding) or follow-on formula (i.e., foodstuffs intended for particular nutritional use by infants when appropriate complementary feeding is introduced and constituting the principal liquid element in a progressively diversified diet of such infants) supplemented with probiotics and/or prebiotics during the manufacturing process were the only studies included. Studies in which probiotics/prebiotics were introduced during the manufacturing process, but administered thereafter, for example in capsules, the contents of which were supplemented to infant formula, were excluded. Formulae manufactured from cow's milk proteins or any other proteins, and formulae based on protein hydrolysates were eligible for inclusion.
For the purposes of this document, the definitions of probiotics, prebiotics, and synbiotics most commonly used in the literature were adopted. Therefore, probiotics are defined as microbial food supplements which, when administered in adequate amounts, have a beneficial effect on the host (1). Prebiotics are defined as non-digestible food ingredients that affect the host by selectively targeting growth and/or the activity of one or more bacteria in the colon that can improve health (2). Synbiotics are defined as a combination of prebiotics and probiotics that beneficially affects the host by improving survival and implantation of live microbial dietary supplements in the gastrointestinal tract (3). Fermented infant formulae (i.e., formulae that have been fermented with lactic acid-producing bacteria during the production process but do not contain significant amounts of viable bacteria in the final product due to inactivation of the fermenting bacteria by heat or other means) (4) are not considered in this review.
Types of outcome measures

The primary interest was in clinically relevant efficacy outcomes, such as those related to a reduced risk of disease, as well as in outcomes related to safety. The latter include both growth parameters and adverse events, such as sepsis and/or death due to probiotic administration (5). In regard to growth, the Committee considered that any study evaluating growth should include at least the following growth parameters: weight, length, and head circumference. To assess growth, the duration of the study should be at least three months. As a minimum, the study should have a power to detect a difference in weight gain equal to 0.5 SD (Koletzko 20026 Aggett 20017). For completeness, studies that reported laboratory or immunological parameters were also considered. However, the Committee notes that these are only indirect markers of a health benefit, which may be relevant when associated with other parameters objectively assessed in RCT in target populations using a specific probiotic and/or prebiotic product.

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