Functional Evaluation of Two Infant Formula Supplemented With Probiotics Isolated From Breast Milk

Biosearch S.A.2 sites in 1 country236 target enrollmentJanuary 2011

ConditionsInfant Nutrition

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Infant Nutrition
Sponsor: Biosearch S.A.
Enrollment: 236
Locations: 2
Primary Endpoint: Body weight gain
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

A randomized double blinded controlled study including infants at the age of 1 month . Infants are assigned randomly to either infant formula supplemented with B. breve CECT7263 or L.fermentum CECT5716 (Probiotic groups), or the same formula without the probiotic strain (Control group). The primary outcome of the study is the body weight gain of infants. Secondary outcomes are incidence of infections, symptoms related with intestinal function, and fecal microbiota

Registry

clinicaltrials.gov

Start Date

January 2011

End Date

December 2015

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Biosearch S.A.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Newborn infants at term (37-42 weeks gestational age) healthy during the first month of life, for reasons unrelated to the study, abandon breastfeeding during the first month of life.
•Signature of informed parental or guardian consent.

Exclusion Criteria

•Allergic to the protein in cow's milk.
•Lactose intolerant.
•Suffering from a serious metabolic disease.
•They have experienced or are experiencing some severe gastrointestinal disease.
•Receive some form of chronic medication or are receiving antibiotics at the time of capture.
•Low expectation of compliance with the study protocol.
•allergic to any group of antibiotics.

Outcomes

Primary Outcomes

Body weight gain

Time Frame: 12 months versus baseline

Body weight gain at 12 months (grams)

Secondary Outcomes

Length(1,2,4,6,9 and 12 months of age)
Body weight(1,2,4,6,9 and 12 months of age)
Incidence of infections(total incidence during intervention (11 months))
Bacterial load in feces(1,2,4,6,9 and 12 months of age)
Regurgitation(each 2 weeks until 6 months of age and monthly until 12 months of age)
Fecal deposition(each 2 weeks until 6 months of age and monthly until 12 months of age)
Infant colic(each 2 weeks until 6 months of age and monthly until 12 months of age)
Flatulency(each 2 weeks until 6 months of age and monthly until 12 months of age)
Hours of night sleep(each 2 weeks until 6 months of age and monthly until 12 months of age)
Total hours of sleep/day(each 2 weeks until 6 months of age and monthly until 12 months of age)