Official registration: ClinicalTrials.gov, Identifier: NCT03371615
Study Objectives
The primary objective of this study is to assess gastrointestinal (GI) tolerance of a renewed anti-regurgitation (AR) formula containing carob bean gum (CBG) prebiotics and postbiotics compared to a control product (a currently marketed anti-regurgitation formula containing CBG and postbiotics) based on GI symptoms score
Secondary outcomes are stool characteristics, safety and growth and the severity of regurgitation of the investigational product compared to the control product.
Background
During infancy, the structure and function of the GI tract, the nervous system and gut microbiota are still maturing, which may cause GI signs and symptoms that have no obvious structural or biochemical cause. One in two infants show at least one FGID from birth to six months1Iacono G, Merolla R, D’Amico D, et al. Gastrointestinal symptoms in infancy: a population-based prospective study. Dig Liver Dis. Published on 2005;37(6):432-438 ,2Vandenplas Y, Abkari A, Bellaiche M, et al. Prevalence and Health Outcomes of Functional Gastrointestinal Symptoms in Infants From Birth to 12 Months of Age. J Pediatr Gastroenterol Nutr. Published … Continue reading World-wide prevalence of most common FGIDs (2) include regurgitation (30%), infantile colic (20%) and functional constipation (15%).
To support healthcare professionals and families in the dietary management of infant regurgitation and reflux, a new advanced AR formula is developed. It contains CBG to increase feed viscosity and to reduce regurgitation. For benefits beyond regurgitation (improving gut microbiota composition and stool characteristics) it additionally contains the unique combination of Nutricia’s prebiotics scGOS/lcFOS (9:1) and postbiotics. The postbiotics derive from the LactofidusTM fermentation process in which two unique and proprietary strains, Bifidobacterium breve C50 and Streptococcus thermophilus 065, are used to ferment a milk matrix.
Methodology
This study is a randomised, controlled, double-blind trial to evaluate the tolerance and safety of the new anti-regurgitation infant formula containing CBG, prebiotics and postbiotics in infants with regurgitation.
Enrolment started end 2017 with the aim of recruiting 180 infants. Parents/guardians of infants are assigned to one of the randomised groups and requested to feed their infant with either a renewed anti-regurgitation formula containing carob bean gum (CBG) prebiotics and postbiotics or a control product (the currently marketed anti-regurgitation formula containing CBG and postbiotics).
The infants that are included are singleton healthy term infant aged 3 – 13 weeks, with normal birth weight for gestational age and gender. The infants suffer from regurgitation, but are otherwise healthy, based upon the following criteria: 1) Regurgitation of 2 or more times per day for 1 or more weeks according to reported history, 2) an indication for the use of AR formula according to the investigator at screening/randomisation. At inclusion they are fully formula fed for at least 7 days before randomisation.
Countries
Poland, France, Germany
Duration
The study contains a main study phase of 4 weeks of intervention, and an optional additional intervention of 4 weeks until a maximum age of 17 weeks.
View References
| 1 | Iacono G, Merolla R, D’Amico D, et al. Gastrointestinal symptoms in infancy: a population-based prospective study. Dig Liver Dis. Published on 2005;37(6):432-438 |
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| 2 | Vandenplas Y, Abkari A, Bellaiche M, et al. Prevalence and Health Outcomes of Functional Gastrointestinal Symptoms in Infants From Birth to 12 Months of Age. J Pediatr Gastroenterol Nutr. Published on 2015;61(5):531-537 |
