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

Not Applicable

Completed

• Conditions: Infant Nutrition
• Interventions: Dietary Supplement: Lfer; Dietary Supplement: Bifido; Other: Control

• Registration Number: NCT03204630
• Lead Sponsor: Biosearch S.A.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2014-11
• Study Completion: 2015-12
• Status Verified: 2016-08
• Study First Submitted: 2016-08-11
• Study First Submitted QC: 2017-06-28
• Last Update Submitted: 2017-06-28
• Study First Posted: 2017-07-02
• Last Update Posted: 2017-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 236

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lfer	Lfer	Infant formula containing Lactobacillus fermentum CECT5716
Bifido	Bifido	Infant formula containing Bifidobacterium breve CECT7263
Control	Control	Standard infant formula

Primary Outcome Measures

Name	Time	Method
Body weight gain	12 months versus baseline	Body weight gain at 12 months (grams)

Secondary Outcome Measures

Name	Time	Method
Length	1,2,4,6,9 and 12 months of age	Length (cm)
Body weight	1,2,4,6,9 and 12 months of age	Body weight of infants at different times (kg)
Incidence of infections	total incidence during intervention (11 months)	Events of infections diseases during intervention period (Incidence rate)
Bacterial load in feces	1,2,4,6,9 and 12 months of age	Counts of Lactobacillus, bifidobacteria, bacteroides, clostridium (CFU/g feces)
Regurgitation	each 2 weeks until 6 months of age and monthly until 12 months of age	Measurement by score: 1 = not at all, 2 = regurgitation of small amounts during or shortly after feeding, 3 = larger regurgitation during or shortly after feeding, 4 = minor vomiting with time-lag to prior feeding, and 5 = severe vomiting with considerable loss of fluid.
Fecal deposition	each 2 weeks until 6 months of age and monthly until 12 months of age	Measurement by score:1 = \<1 time, 2 = 1-3, 3 = 4-6, 4 = 7-10, and 5 = \>10.
Infant colic	each 2 weeks until 6 months of age and monthly until 12 months of age	Average crying hours per day during the last two days of each period of measurement which is each 2 weeks until 6 months of age and monthly until 12 months of age. Score: no crying; \< 3 hours/day; 3-6 hours/day; 6-12 hours/day; \> 12 hours/day
Flatulency	each 2 weeks until 6 months of age and monthly until 12 months of age	Average of duration of flatulence episodes (hours per day) during the last two days of each period of measurement which is each 2 weeks until 6 months of age and monthly until 12 months of age.Measurement by the score:no flatulency; \< 3 hours/day; 3-6 hours/day; 6-12 hours/day; \> 12 hours/day
Hours of night sleep	each 2 weeks until 6 months of age and monthly until 12 months of age	Average of time of night sleep (hours per day) during the last two days of each period of measurement which is each 2 weeks until 6 months of age and monthly until 12 months of age.Measurement by the score: \< 4 hours ; 4-6 hours; 6-9 hours; 9-12 hours; \> 12 hours
Total hours of sleep/day	each 2 weeks until 6 months of age and monthly until 12 months of age	Average of total time of sleep (hours per day) during the last two days of each period of measurement which is each 2 weeks until 6 months of age and monthly until 12 months of age.Measurement by the score: \< 11 hours;  11-14 hours; 14-17 hours; 17-20 hours;  \> 20 hours

Trial Locations

Locations (2)

Servicio Andaluz de Salud; 🇪🇸 Granada, Spain

Hospital Reina Sofía; 🇪🇸 Córdoba, Spain