The Effects of an Infant Formula Containing Probiotic CECT7210 on Gastrointestinal Health (GO-INF)

Evaluar el Efecto de Una fórmula Infantil Enriquecida Con el probiótico CECT7210 Sobre la Incidencia de Infecciones Gastrointestinales

The purpose of this study is to determine whether an infant formula supplemented with a new probiotic CECT7210, is effective in reducing the incidence of infections, specially the gastrointestinal ones.

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Diseases
• Intervention / Treatment: Dietary supplement: Infant Formula with a novel probiotic CECT7210; Dietary supplement: Standard formula

Detailed Description

This a multicenter, controlled, randomized, prospective, parallel, double-blinded study to evaluate the effect of an infant formula containing a new probiotic, Bifidobacterium longum biovar infantis CECT7210, on the incidence of diarrhea in healthy infants born at term. Infants will be randomized to take an standard infant formula or the infant formula with the probiotic CECT7210 during 12 weeks.

• Study Type: Interventional
• Enrollment (Actual): 194
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain
    • Hospital Universitario La Paz
  • Tarragona, Spain
    • Hospital Joan XXIII
  • Tarragona
    • Reus, Tarragona, Spain
      • Hospital Sant Joan de Reus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 months (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Full-term healthy newborns (>= 37 weeks)
• Birth weight between >=2.500g and <=4.500g)
• Normal growth curve (between 3-97 percentiles)
• 0-60 days of age on enrolment
• Maximum 30 days of breastfeeding
• Exclusively infant formula on enrolment
• Breastfeeding or infant formula with pre/probiotics feeding stopped 15 days before enrolment
• Parents or caregivers agree to exclude any source of prebiotics or probiotics during the study
• Parents or caregivers agree to follow-on the study 12 weeks
• Informed consent signed ( Parent/Legal representative)

Exclusion Criteria:

• Congenital illness or malformation that may affect infant feeding and /or normal growth
• Significant pre-natal or post-natal diseases
• Infant's family history of atopy
• Any pathology related to the immune or gastrointestinal system.
• Suspected or known allergy to cow's milk protein
• Infants receiving pre or probiotics within less than 15 days prior to enrolment
• Infant's family who in the investigator's assessment cannot be expected to comply with the protocol

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Formula; Infant formula with a novel probiotic CECT7210	Dietary supplement: Infant Formula with a novel probiotic CECT7210; Bottle-feeding with a new infant formula enriched with probiotic CECT7210 during the first 3 months of life.
Active Comparator: Standard Formula; Standard infant formula without probiotics	Dietary supplement: Standard formula; Standard formula without probiotics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in diarrhea incidence	Differences between diarrhea incidence amongst groups from baseline to 12th weeks.	At 4th, 8th, 12th weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in infections incidence	Differences between rate of infections or duration amongst groups.	At 4th, 8th, 12th weeks.
Changes in microbiota	Differences between faecal bacterial populations.	At 4th, 8th, 12th weeks
Changes in Immunoglobulin A secretor (IgAs)	Differences between faecal IgAs amongst groups.	At 4th and 12th weeks
Tolerability of the product	To evaluate gastrointestinal tolerability of both study formulas.	At 4th, 8th and 12th weeks
Growth	To compare anthropometric measurements between probiotic CECT7210 formula group and standard group.	At 4th, 8th and 12th weeks

Collaborators and Investigators

• Sponsor: Laboratorios Ordesa
• Collaborators: Harrison Clinical Research
• Investigators: Study Chair: Isabel Polanco, Professor, Hospital Universitario La Paz; Principal Investigator: Joaquin Escribano, Professor, Hospital Sant Joan de Reus, Reus, Spain; Principal Investigator: Ricardo Closa, Professor, Hospital Joan XXIII de Tarragona, Tarragona, Spain

Publications and helpful links

General Publications

• Closa R, Ferré N, Luque V, Gispert-Llaurado M, Ruibio-Torrents C, Polanco I, Morera M, Moreno JA, Rivero M, Escribano J. Effect of probiotic CECT7210 supplementation of infant formula in healthy infants. ESPGHAN Abstracts Book. JPGN. Vol. 60, Supplement 1, May 2015. PA-N-0038.
• Moreno JA, Cifuentes GC, Morera M, Martínez-Blach JF, Codoñer F, Genovés S, Chenoll E, Polanco I, Closa R, Escribano J, Ferré N, Luque V, Rivero M. Feeding infant formula supplemented with the probiotic bacteria bifidobacterium longum subsp.infantis CECT7210 produce beneficial changes in gastointestinal microbial communities: a metagenomic approach. ESPGHAN Abstracts Book. JPGN. Vol. 60, Supplement 1, May 2015. PO-N-0361.

Helpful Links

• ESPGHAN 2015 Annual Meeting - Abstracts Book - JPGN. Vol. 60, Supplement 1, May 2015.

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: March 20, 2014
• First Submitted That Met QC Criteria: March 21, 2014
• First Posted (Estimate): March 26, 2014

Study Record Updates

• Last Update Posted (Actual): July 19, 2019
• Last Update Submitted That Met QC Criteria: July 17, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Microbiota; Probiotics; Growth; Infant Formula; Bifidobacterium longum biovar infantis CECT7210
• Additional Relevant MeSH Terms: Gastrointestinal Diseases; Digestive System Diseases
• Other Study ID Numbers: GO-INF-010