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Trial record 1 of 1 for:    NCT02096302.
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The Effects of an Infant Formula Containing Probiotic CECT7210 on Gastrointestinal Health (GO-INF)

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ClinicalTrials.gov Identifier: NCT02096302
Recruitment Status : Completed
First Posted : March 26, 2014
Last Update Posted : July 19, 2019
Sponsor:
Collaborator:
Harrison Clinical Research
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Gastrointestinal Diseases Dietary Supplement: Infant Formula with a novel probiotic CECT7210 Dietary Supplement: Standard formula Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : January 2011
Actual Primary Completion Date : November 2012
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Changes in diarrhea incidence [ Time Frame: At 4th, 8th, 12th weeks ]
    Differences between diarrhea incidence amongst groups from baseline to 12th weeks.


Secondary Outcome Measures :
  1. Changes in infections incidence [ Time Frame: At 4th, 8th, 12th weeks. ]
    Differences between rate of infections or duration amongst groups.

  2. Changes in microbiota [ Time Frame: At 4th, 8th, 12th weeks ]
    Differences between faecal bacterial populations.

  3. Changes in Immunoglobulin A secretor (IgAs) [ Time Frame: At 4th and 12th weeks ]
    Differences between faecal IgAs amongst groups.

  4. Tolerability of the product [ Time Frame: At 4th, 8th and 12th weeks ]
    To evaluate gastrointestinal tolerability of both study formulas.

  5. Growth [ Time Frame: At 4th, 8th and 12th weeks ]
    To compare anthropometric measurements between probiotic CECT7210 formula group and standard group.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 90 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02096302


Locations
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Spain
Hospital Sant Joan de Reus
Reus, Tarragona, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital Joan XXIII
Tarragona, Spain
Sponsors and Collaborators
Laboratorios Ordesa
Harrison Clinical Research
Investigators
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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
Additional Information:
Publications of Results:
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.

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Responsible Party: Laboratorios Ordesa
ClinicalTrials.gov Identifier: NCT02096302    
Other Study ID Numbers: GO-INF-010
First Posted: March 26, 2014    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: July 2019
Keywords provided by Laboratorios Ordesa:
Probiotics
Infant Formula
Microbiota
Bifidobacterium longum biovar infantis CECT7210
Growth
Additional relevant MeSH terms:
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Gastrointestinal Diseases
Digestive System Diseases