The Effects of an Infant Formula Containing Probiotic CECT7210 on Gastrointestinal Health

Not Applicable

Completed

• Conditions: Gastrointestinal Diseases

• Registration Number: NCT02096302
• Lead Sponsor: Laboratorios Ordesa

Brief Summary

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.

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 Timeline

• Study Start: 2011-01
• Primary Completion: 2012-11
• Study Completion: 2013-06
• Study First Submitted: 2014-03-20
• Study First Submitted QC: 2014-03-21
• Study First Posted: 2014-03-26
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-17
• Last Update Posted: 2019-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 194

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in diarrhea incidence	At 4th, 8th, 12th weeks	Differences between diarrhea incidence amongst groups from baseline to 12th weeks.

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Hospital Sant Joan de Reus; 🇪🇸 Reus, Tarragona, Spain

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain

Hospital Joan XXIII; 🇪🇸 Tarragona, Spain