Evaluation of the Efficacy and Safety of an Infant Formula Containing Synbiotics and Its Effects on the Incidence of Infectious Diseases in the Infant Gut : a Double-blind, Randomized, Controlled Interventional Study

HiPP GmbH & Co. Vertrieb KG25 sites in 1 country540 target enrollmentAugust 2014

ConditionsHealthy Term Infants

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Healthy Term Infants
Sponsor: HiPP GmbH & Co. Vertrieb KG
Enrollment: 540
Locations: 25
Primary Endpoint: (Cumulative) number of infectious diarrhea episodes per subject during the first year of life.
Status: Terminated
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

August 2014

End Date

April 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

HiPP GmbH & Co. Vertrieb KG

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy term infants
•Female or male gender
•Gestational age between 37 and 41 weeks completed (= 41 weeks + 6 days)
•Age at time of V1 visit : 4 +/- 7 days
•Birth weight between 2500 ans 4200g, with regular weight gain (≥ 150g / week)
•Two legal representatives (parent(s) / guardian(s)) who are capable of and willing to comply with the protocol and have signed the informed consent in accordance with legal requirements.
•at least one of the legal representatives is affiliated to with a social security scheme.
•Additionnaly , criteria of inclusion in one of the formula-fed groups or in the breast-fed group, respectively, are the following:
•To be included in one of the formula arm, infants will have to be exclusively formula-fed (no breast milk meal) at the time of V1 visit (randomization).
•To be included in the breastfeeding arm, infants will have to be exclusively breast-fed (no more than one formula meal per day) at V1 visit (randomization) and its mother will have to be willing to pursue exclusive breastfeeding at least until the infant will be 4-month old.

Exclusion Criteria

•Intensive care during at least the first 14 days of life
•Neonatal health problems, such as: respiratory distress, asphyxia, hypoglycemia, sepsis, NEC (necrotizing enterocolitis),...
•Clinical evidence of chronic illness or gastrointestinal disorders such as : GER (Gastrooesophageal Reflux), gastroenteritis,...
•Known metabolic disorders, such as diabetes, lactose intolerance,....
•Known immune deficiency
•Subjects recommended to receive formula with hydrolized protein (e.g. children with allergy risk)
•Subject under oral antibiotic treatment at V1 visit
•Participation in another biomedical study
•Whose legal representatives have psychological or linguistic incapability to sign the informed consent form
•Reasons to presume that parents are unable to meet the study plan requirements (e.g. impossibility to contact study representatives in case of emergency, drug addiction etc)

Outcomes

Primary Outcomes

(Cumulative) number of infectious diarrhea episodes per subject during the first year of life.

Time Frame: one year

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.

Secondary Outcomes

Levels of fecal IgA and fecal calprotectin in planned stool samples(3 years)
Adverse events (AE)(3 years)
Fecal pH and levels of short chain fatty acids (SCFA) in planned stool samples(3 years)
Characteristics of bowel movements during diarrhea episodes(1 year)
Number and duration of antibiotic treatment.(1 year)
Suitability for daily use(3 years)
Infants growth measured by anthropometric measurements(3 years)
Child's behavior(3 years)
Minor gastrointestinal disorders (digestive tolerance)(3 years)
Analysis of fecal microbiota by molecular analysis from frozen stools in diarrhea samples(1 year)
Characteristics of bowel movements and stools(3 years)
Number and duration of infectious diseases(1 year)
Analysis of fecal microbiota by molecular analysis from frozen stools in planned stool samples(3 years)
Number and duration of fever episodes;(1 year)