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

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 Overview

• Status: Completed
• Conditions: Infant Nutrition
• Intervention / Treatment: Dietary supplement: Bifido; Dietary supplement: Lfer; Other: Control

• Study Type: Interventional
• Enrollment (Actual): 236
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Córdoba, Spain, 14004
    • Hospital Reina Sofia
  • Granada, Spain, 10012
    • Servicio Andaluz de Salud

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 weeks to 1 month (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Bifido; Infant formula containing Bifidobacterium breve CECT7263	Dietary supplement: Bifido; Probiotic bacteria originally isolated from breast milk: the strain Bifidobacterium breve CECT7263
Active Comparator: Lfer; Infant formula containing Lactobacillus fermentum CECT5716	Dietary supplement: Lfer; Probiotic bacteria originally isolated from breast milk: the strain Lactobacillus fermentum CECT5716
Placebo Comparator: Control; Standard infant formula	Other: Control; Standard infant formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body weight gain	Body weight gain at 12 months (grams)	12 months versus baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length	Length (cm)	1,2,4,6,9 and 12 months of age
Body weight	Body weight of infants at different times (kg)	1,2,4,6,9 and 12 months of age
Incidence of infections	Events of infections diseases during intervention period (Incidence rate)	total incidence during intervention (11 months)
Bacterial load in feces	Counts of Lactobacillus, bifidobacteria, bacteroides, clostridium (CFU/g feces)	1,2,4,6,9 and 12 months of age
Regurgitation	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.	each 2 weeks until 6 months of age and monthly until 12 months of age
Fecal deposition	Measurement by score:1 = <1 time, 2 = 1-3, 3 = 4-6, 4 = 7-10, and 5 = >10.	each 2 weeks until 6 months of age and monthly until 12 months of age
Infant colic	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	each 2 weeks until 6 months of age and monthly until 12 months of age
Flatulency	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	each 2 weeks until 6 months of age and monthly until 12 months of age
Hours of night sleep	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	each 2 weeks until 6 months of age and monthly until 12 months of age
Total hours of sleep/day	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	each 2 weeks until 6 months of age and monthly until 12 months of age

Collaborators and Investigators

• Sponsor: Biosearch S.A.
• Collaborators: Andaluz Health Service; Maimónides Biomedical Research Institute of Córdoba

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: August 11, 2016
• First Submitted That Met QC Criteria: June 28, 2017
• First Posted (Actual): July 2, 2017

Study Record Updates

• Last Update Posted (Actual): July 2, 2017
• Last Update Submitted That Met QC Criteria: June 28, 2017
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: probiotic; infant nutrition
• Other Study ID Numbers: P024