Clinical trial NCT03204630: Functional Evaluation of Two Infant Formula Supplemented With Probiotics Isolated From Breast Milk
Official title: Functional Evaluation of Two Infant Formula Supplemented With Probiotics Isolated From Breast Milk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant Nutrition
Keywords: infant nutrition
probiotic
Lead sponsor: Biosearch S.A.
Sponsor class: INDUSTRY
Collaborators: name: Maimónides Biomedical Research Institute of Córdoba
name: Andaluz Health Service
First posted: 2017-07-02
Enrollment: 236
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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


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.

Primary outcomes:
measure: Body weight gain
timeFrame: 12 months versus baseline
Secondary outcomes:
measure: Length
timeFrame: 1,2,4,6,9 and 12 months of age
measure: Body weight
timeFrame: 1,2,4,6,9 and 12 months of age
measure: Incidence of infections
timeFrame: total incidence during intervention (11 months)
measure: Bacterial load in feces
timeFrame: 1,2,4,6,9 and 12 months of age
measure: Regurgitation
timeFrame: each 2 weeks until 6 months of age and monthly until 12 months of age
measure: Fecal deposition
timeFrame: each 2 weeks until 6 months of age and monthly until 12 months of age
measure: Infant colic
timeFrame: each 2 weeks until 6 months of age and monthly until 12 months of age
measure: Flatulency
timeFrame: each 2 weeks until 6 months of age and monthly until 12 months of age
measure: Hours of night sleep
timeFrame: each 2 weeks until 6 months of age and monthly until 12 months of age
measure: Total hours of sleep/day
timeFrame: each 2 weeks until 6 months of age and monthly until 12 months of age
Other outcomes:
Locations:
city: Córdoba
country: Spain
facility: Hospital Reina Sofía
city: Granada
country: Spain
facility: Servicio Andaluz de Salud
Study officials:
References:
citation: Maldonado J, Gil-Campos M, Maldonado-Lobon JA, Benavides MR, Flores-Rojas K, Jaldo R, Jimenez Del Barco I, Bolivar V, Valero AD, Prados E, Penalver I, Olivares M. Evaluation of the safety, tolerance and efficacy of 1-year consumption of infant formula supplemented with Lactobacillus fermentum CECT5716 Lc40 or Bifidobacterium breve CECT7263: a randomized controlled trial. BMC Pediatr. 2019 Oct 21;19(1):361. doi: 10.1186/s12887-019-1753-7.