Trial | NCT03204630  Report issue

Official Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    236
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
Study Started
Jan 31
2011
Primary Completion
Nov 30
2014
Study Completion
Dec 31
2015
Last Update
Jul 02
2017

Dietary Supplement Lfer

Probiotic bacteria originally isolated from breast milk: the strain Lactobacillus fermentum CECT5716

Dietary Supplement Bifido

Probiotic bacteria originally isolated from breast milk: the strain Bifidobacterium breve CECT7263

Other Control

Standard infant formula

Bifido Active Comparator

Infant formula containing Bifidobacterium breve CECT7263

Lfer Active Comparator

Infant formula containing Lactobacillus fermentum CECT5716

  • Dietary Supplement Lfer

Control Placebo Comparator

Standard infant formula

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.
No Results Posted