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

Sponsor

Laboratorios Ordesa (Industry)

Overall Status

Completed

CT.gov ID

NCT02096302

Collaborator

Harrison Clinical Research (Industry)

194

Enrollment

Locations

Arms

Duration (Months)

64.7

Patients Per Site

2.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastrointestinal Diseases	Dietary Supplement: Infant Formula with a novel probiotic CECT7210 Dietary Supplement: Standard formula	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

194 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Jan 1, 2011

Actual Primary Completion Date :

Nov 1, 2012

Actual Study Completion Date :

Jun 1, 2013

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Changes in diarrhea incidence [At 4th, 8th, 12th weeks]
Differences between diarrhea incidence amongst groups from baseline to 12th weeks.

Secondary Outcome Measures

Changes in infections incidence [At 4th, 8th, 12th weeks.]
Differences between rate of infections or duration amongst groups.
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 90 Days

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country
1	Hospital Sant Joan de Reus	Reus	Tarragona	Spain
2	Hospital Universitario La Paz	Madrid		Spain
3	Hospital Joan XXIII	Tarragona		Spain

Sponsors and Collaborators

Laboratorios Ordesa
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