The primary objective of this study is to demonstrate that a synbiotic formula, fed for the duration of the first year of life (infant and follow-on formula) reduces the incidence rate of episodes of infectious diarrhea in infants during the first year of life compared to a standard infant formula.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
540
Standard milk formula enriched with a prebiotic fiber and a probiotic strain
Standard milk formula without pre and probiotic
Elie JABBOUR
Gémozac, Charente-Maritime, France
(Cumulative) number of infectious diarrhea episodes per subject during the first year of life.
Difference between formula groups are evaluated via incidence rate based on number of subjects. In formula-fed infants, diarrhea is defined as three or more loose or watery stools in 24 hours with or without fever or vomiting (according to WHO and ESPGHAN definition). For breast-fed infants, a change in stool consistency versus previous stool consistency is more indicative of diarrhea than stool number. Diarrhea episode is considered as ended as soon as 2 consecutive non-watery stools are observed or no stools are observed in 24 hours.
Time frame: one year
Analysis of fecal microbiota by molecular analysis from frozen stools in planned stool samples
Levels of total lactobacilli, Lactobacillus fermentum species (and if possible the strain CECT 5716 will be quantified too), total bifidobacteria, enterobacteriaceae, clostridium difficile
Time frame: 4 months
Analysis of fecal microbiota by molecular analysis from frozen stools in planned stool samples
Levels of total lactobacilli, Lactobacillus fermentum species (and if possible the strain CECT 5716 will be quantified too), total bifidobacteria, enterobacteriaceae, clostridium difficile
Time frame: 1 year
Analysis of fecal microbiota by molecular analysis from frozen stools in planned stool samples
Levels of total lactobacilli, Lactobacillus fermentum species (and if possible the strain CECT 5716 will be quantified too), total bifidobacteria, enterobacteriaceae, clostridium difficile
Time frame: 2 years
Analysis of fecal microbiota by molecular analysis from frozen stools in planned stool samples
Levels of total lactobacilli, Lactobacillus fermentum species (and if possible the strain CECT 5716 will be quantified too), total bifidobacteria, enterobacteriaceae, clostridium difficile
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Christophe VIEL
La Rochelle, Charente-Maritime, France
C.I.C Pédiatrique - C.H.U. de Grenoble - Hôpital Couple-Enfant
Grenoble, Isère, France
C.I.C pédiatrique - C.H.U. de Nantes - Hôpital Mère-Enfant
Nantes, Loire-Atlantique, France
Alain PALOMBA
Angers, Maine-et-Loire, France
Christophe RONDEAU
Angers, Maine-et-Loire, France
Damien GODIN
Angers, Maine-et-Loire, France
Daniel GOMBAUD
Angers, Maine-et-Loire, France
Jean-François FOUCAULT
Angers, Maine-et-Loire, France
Michel LAMBERT
Angers, Maine-et-Loire, France
...and 15 more locations
Time frame: 3 years
Analysis of fecal microbiota by molecular analysis from frozen stools in diarrhea samples
levels of potential pathogens causing diarrhea including rotavirus, norovirus, Salmonella enterica, Campylobacter jejuni, Clostridium difficile, Clostridium perfringens, Escherichia coli (potential pathogenic bacteria will be screened only in case of negative testing for viruses on sample collected within 72 hours after beginning of the diarrhea episode);
Time frame: 1 year
Fecal pH and levels of short chain fatty acids (SCFA) in planned stool samples
short chain fatty acids (SCFA): acetate, propionate, butyrate;
Time frame: 4 months
Fecal pH and levels of short chain fatty acids (SCFA) in planned stool samples
short chain fatty acids (SCFA): acetate, propionate, butyrate;
Time frame: 1 year
Fecal pH and levels of short chain fatty acids (SCFA) in planned stool samples
short chain fatty acids (SCFA): acetate, propionate, butyrate;
Time frame: 2 years
Fecal pH and levels of short chain fatty acids (SCFA) in planned stool samples
short chain fatty acids (SCFA): acetate, propionate, butyrate;
Time frame: 3 years
Characteristics of bowel movements and stools
\- assessed through a 3-day diary filled in by parents * average daily number of bowel movements; * (average daily) Infant Stool Form scores consistency (4-point scale), amount (4-point scale) and color (6 categories) (using the validated scale for preterm and term infants proposed by Bekkali N, et al., 2009), and especially * average daily incidence of loose or watery stools (category A, subscale 'consistency' on Bekkali scale); * dominant stool color per visit
Time frame: 4 months
Characteristics of bowel movements and stools
\- assessed through a 3-day diary filled in by parents * average daily number of bowel movements; * (average daily) Infant Stool Form scores consistency (4-point scale), amount (4-point scale) and color (6 categories) (using the validated scale for preterm and term infants proposed by Bekkali N, et al., 2009), and especially * average daily incidence of loose or watery stools (category A, subscale 'consistency' on Bekkali scale); * dominant stool color per visit
Time frame: 6 months
Characteristics of bowel movements and stools
\- assessed through a 3-day diary filled in by parents * average daily number of bowel movements; * (average daily) Infant Stool Form scores consistency (4-point scale), amount (4-point scale) and color (6 categories) (using the validated scale for preterm and term infants proposed by Bekkali N, et al., 2009), and especially * average daily incidence of loose or watery stools (category A, subscale 'consistency' on Bekkali scale); * dominant stool color per visit
Time frame: 9 months
Characteristics of bowel movements and stools
\- assessed through a 3-day diary filled in by parents * average daily number of bowel movements; * (average daily) Infant Stool Form scores consistency (4-point scale), amount (4-point scale) and color (6 categories) (using the validated scale for preterm and term infants proposed by Bekkali N, et al., 2009), and especially * average daily incidence of loose or watery stools (category A, subscale 'consistency' on Bekkali scale); * dominant stool color per visit
Time frame: 1 year
Characteristics of bowel movements and stools
\- assessed through a 3-day diary filled in by parents * average daily number of bowel movements; * (average daily) Infant Stool Form scores consistency (4-point scale), amount (4-point scale) and color (6 categories) (using the validated scale for preterm and term infants proposed by Bekkali N, et al., 2009), and especially * average daily incidence of loose or watery stools (category A, subscale 'consistency' on Bekkali scale); * dominant stool color per visit
Time frame: 2 years
Characteristics of bowel movements and stools
\- assessed through a 3-day diary filled in by parents * average daily number of bowel movements; * (average daily) Infant Stool Form scores consistency (4-point scale), amount (4-point scale) and color (6 categories) (using the validated scale for preterm and term infants proposed by Bekkali N, et al., 2009), and especially * average daily incidence of loose or watery stools (category A, subscale 'consistency' on Bekkali scale); * dominant stool color per visit
Time frame: 3 years
Characteristics of bowel movements during diarrhea episodes
\- assessed through a diary filled in by parents during diarrhea episodes * average daily number of bowel movements per diarrhea episode; * average duration (number of days) of diarrhea episodes; * total number of days with diarrhea, within the first year of age (between V1 and V5); * (average daily) Infant Stool Form scores consistency (4-point scale), amount (4-point scale) and color (6 categories) per diarrhea episode.
Time frame: 1 year
Levels of fecal IgA and fecal calprotectin in planned stool samples
Time frame: 4 months
Levels of fecal IgA and fecal calprotectin in planned stool samples
Time frame: 1 year
Levels of fecal IgA and fecal calprotectin in planned stool samples
Time frame: 2 years
Levels of fecal IgA and fecal calprotectin in planned stool samples
Time frame: 3 years
Number and duration of infectious diseases
Especially: otitis media, infections of upper and lower respiratory tract and of urinary tract;
Time frame: 3 years
Number and duration of fever episodes;
Time frame: 3 years
Number and duration of antibiotic treatment.
Time frame: 3 years
Infants growth measured by anthropometric measurements
weight, size, head circumference;
Time frame: 4 weeks
Infants growth measured by anthropometric measurements
weight, size, head circumference;
Time frame: 4 months
Infants growth measured by anthropometric measurements
weight, size, head circumference;
Time frame: 6 months
Infants growth measured by anthropometric measurements
weight, size, head circumference;
Time frame: 9 months
Infants growth measured by anthropometric measurements
weight, size, head circumference;
Time frame: 1 year
Infants growth measured by anthropometric measurements
weight, size, head circumference;
Time frame: 2 years
Infants growth measured by anthropometric measurements
weight, size, head circumference;
Time frame: 3 years
Child's behavior
Assessed through a 3-day diary filled in by parents \- Average sleep duration and crying duration per 24 hours;
Time frame: 4 months
Child's behavior
Assessed through a 3-day diary filled in by parents \- Average sleep duration and crying duration per 24 hours;
Time frame: 6 months
Child's behavior
Assessed through a 3-day diary filled in by parents \- Average sleep duration and crying duration per 24 hours;
Time frame: 9 months
Child's behavior
Assessed through a 3-day diary filled in by parents \- Average sleep duration and crying duration per 24 hours;
Time frame: 1 year
Child's behavior
Assessed through a 3-day diary filled in by parents \- Average sleep duration and crying duration per 24 hours;
Time frame: 2 years
Child's behavior
Assessed through a 3-day diary filled in by parents \- Average sleep duration and crying duration per 24 hours;
Time frame: 3 years
Minor gastrointestinal disorders (digestive tolerance)
Assessed through a 3-day diary filled in by parents \- average daily vomiting, regurgitation/reflux, flatulence, constipation (according to WHO definition);
Time frame: 4 months
Minor gastrointestinal disorders (digestive tolerance)
Assessed through a 3-day diary filled in by parents \- average daily vomiting, regurgitation/reflux, flatulence, constipation (according to WHO definition);
Time frame: 6 months
Minor gastrointestinal disorders (digestive tolerance)
Assessed through a 3-day diary filled in by parents \- average daily vomiting, regurgitation/reflux, flatulence, constipation (according to WHO definition);
Time frame: 9 months
Minor gastrointestinal disorders (digestive tolerance)
Assessed through a 3-day diary filled in by parents \- average daily vomiting, regurgitation/reflux, flatulence, constipation (according to WHO definition);
Time frame: 1 year
Minor gastrointestinal disorders (digestive tolerance)
Assessed through a 3-day diary filled in by parents \- average daily vomiting, regurgitation/reflux, flatulence, constipation (according to WHO definition);
Time frame: 2 years
Minor gastrointestinal disorders (digestive tolerance)
Assessed through a 3-day diary filled in by parents \- average daily vomiting, regurgitation/reflux, flatulence, constipation (according to WHO definition);
Time frame: 3 years
Suitability for daily use
Assessed through a 3-day diary filled in by parents \- average daily consumption: drinking amounts and formula acceptance;
Time frame: 4 months
Suitability for daily use
Assessed through a 3-day diary filled in by parents \- average daily consumption: drinking amounts and formula acceptance;
Time frame: 6 months
Suitability for daily use
Assessed through a 3-day diary filled in by parents \- average daily consumption: drinking amounts and formula acceptance;
Time frame: 9 months
Suitability for daily use
Assessed through a 3-day diary filled in by parents \- average daily consumption: drinking amounts and formula acceptance;
Time frame: 1 year
Suitability for daily use
Assessed through a 3-day diary filled in by parents \- average daily consumption: drinking amounts and formula acceptance;
Time frame: 2 years
Suitability for daily use
Assessed through a 3-day diary filled in by parents \- average daily consumption: drinking amounts and formula acceptance;
Time frame: 3 years
Adverse events (AE)
Assessed through a 3-day diary filled in by parents \- Number of events, number of subjects showing adverse events, intensity and relationship of AE.
Time frame: 4 months
Adverse events (AE)
Assessed through a 3-day diary filled in by parents \- Number of events, number of subjects showing adverse events, intensity and relationship of AE.
Time frame: 6 months
Adverse events (AE)
Assessed through a 3-day diary filled in by parents \- Number of events, number of subjects showing adverse events, intensity and relationship of AE.
Time frame: 9 months
Adverse events (AE)
Assessed through a 3-day diary filled in by parents \- Number of events, number of subjects showing adverse events, intensity and relationship of AE.
Time frame: 1 year
Adverse events (AE)
Assessed through a 3-day diary filled in by parents \- Number of events, number of subjects showing adverse events, intensity and relationship of AE.
Time frame: 2 years
Adverse events (AE)
Assessed through a 3-day diary filled in by parents \- Number of events, number of subjects showing adverse events, intensity and relationship of AE.
Time frame: 3 years
Number and duration of fever episodes;
Time frame: 1 year
Number and duration of antibiotic treatment.
Time frame: 1 year
Number and duration of infectious diseases
Especially: otitis media, infections of upper and lower respiratory tract and of urinary tract;
Time frame: 1 year