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

Primary Purpose

Gastrointestinal Diseases

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Infant Formula with a novel probiotic CECT7210
Standard formula
Sponsored by
Laboratorios Ordesa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gastrointestinal Diseases focused on measuring Probiotics, Infant Formula, Microbiota, Bifidobacterium longum biovar infantis CECT7210, Growth

Eligibility Criteria

undefined - 90 Days (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hospital Sant Joan de Reus
  • Hospital Universitario La Paz
  • Hospital Joan XXIII

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental Formula

Standard Formula

Arm Description

Infant formula with a novel probiotic CECT7210

Standard infant formula without probiotics

Outcomes

Primary Outcome Measures

Changes in diarrhea incidence
Differences between diarrhea incidence amongst groups from baseline to 12th weeks.

Secondary Outcome Measures

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

Full Information

First Posted
March 20, 2014
Last Updated
July 17, 2019
Sponsor
Laboratorios Ordesa
Collaborators
Harrison Clinical Research
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1. Study Identification

Unique Protocol Identification Number
NCT02096302
Brief Title
The Effects of an Infant Formula Containing Probiotic CECT7210 on Gastrointestinal Health
Acronym
GO-INF
Official Title
Evaluar el Efecto de Una fórmula Infantil Enriquecida Con el probiótico CECT7210 Sobre la Incidencia de Infecciones Gastrointestinales
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratorios Ordesa
Collaborators
Harrison Clinical Research

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Diseases
Keywords
Probiotics, Infant Formula, Microbiota, Bifidobacterium longum biovar infantis CECT7210, Growth

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
194 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Formula
Arm Type
Experimental
Arm Description
Infant formula with a novel probiotic CECT7210
Arm Title
Standard Formula
Arm Type
Active Comparator
Arm Description
Standard infant formula without probiotics
Intervention Type
Dietary Supplement
Intervention Name(s)
Infant Formula with a novel probiotic CECT7210
Intervention Description
Bottle-feeding with a new infant formula enriched with probiotic CECT7210 during the first 3 months of life.
Intervention Type
Dietary Supplement
Intervention Name(s)
Standard formula
Intervention Description
Standard formula without probiotics
Primary Outcome Measure Information:
Title
Changes in diarrhea incidence
Description
Differences between diarrhea incidence amongst groups from baseline to 12th weeks.
Time Frame
At 4th, 8th, 12th weeks
Secondary Outcome Measure Information:
Title
Changes in infections incidence
Description
Differences between rate of infections or duration amongst groups.
Time Frame
At 4th, 8th, 12th weeks.
Title
Changes in microbiota
Description
Differences between faecal bacterial populations.
Time Frame
At 4th, 8th, 12th weeks
Title
Changes in Immunoglobulin A secretor (IgAs)
Description
Differences between faecal IgAs amongst groups.
Time Frame
At 4th and 12th weeks
Title
Tolerability of the product
Description
To evaluate gastrointestinal tolerability of both study formulas.
Time Frame
At 4th, 8th and 12th weeks
Title
Growth
Description
To compare anthropometric measurements between probiotic CECT7210 formula group and standard group.
Time Frame
At 4th, 8th and 12th weeks

10. Eligibility

Sex
All
Maximum Age & Unit of Time
90 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabel Polanco, Professor
Organizational Affiliation
Hospital Universitario La Paz
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Joaquin Escribano, Professor
Organizational Affiliation
Hospital Sant Joan de Reus, Reus, Spain
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ricardo Closa, Professor
Organizational Affiliation
Hospital Joan XXIII de Tarragona, Tarragona, Spain
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Sant Joan de Reus
City
Reus
State/Province
Tarragona
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
Country
Spain
Facility Name
Hospital Joan XXIII
City
Tarragona
Country
Spain

12. IPD Sharing Statement

Citations:
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result
Links:
URL
http://journals.lww.com/jpgn/Documents/ESPGHAN%202015%20-%20Abstracts%20JPGN%20FINAL.pdf
Description
ESPGHAN 2015 Annual Meeting - Abstracts Book - JPGN. Vol. 60, Supplement 1, May 2015.

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

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