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

Gastrointestinal Diseases Clinical Trial

— GO-INF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02096302
• Other study ID #: GO-INF-010
• Status: Completed
• Phase: N/A
• Start date: January 2011
• Est. completion date: June 2013

Study information

• Verified date: July 2019
• Source: Laboratorios Ordesa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 194
• Est. completion date: June 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 90 Days

Eligibility

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

Related Conditions & MeSH terms

• Digestive System Diseases
• Gastrointestinal Diseases

Intervention

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.
• Standard formula
Standard formula without probiotics

Locations

Country	Name	City	State
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Sant Joan de Reus	Reus	Tarragona
Spain	Hospital Joan XXIII	Tarragona

Sponsors (2)

Lead Sponsor	Collaborator
Laboratorios Ordesa	Harrison Clinical Research

Country where clinical trial is conducted

Spain, 

References & Publications (2)

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

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 CECT7

Outcome

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

External Links

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