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Completed

NCT Number: NCT02096302

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

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.

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Key information

Conditions

Gastrointestinal Diseases Digestive System Diseases

Age range

Up to 90 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Sant Joan de Reus, Reus, Tarragona, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Infant Formula with a novel probiotic CECT7210

Dietary Supplement

Bottle-feeding with a new infant formula enriched with probiotic CECT7210 during the first 3 months of life.

Standard formula

Dietary Supplement

Standard formula without probiotics

Primary outcomes

  1. Changes in diarrhea incidence

    Time frame: At 4th, 8th, 12th weeks

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

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Laboratorios Ordesa

Industry

Collaborators

  • Harrison Clinical Research

Registry information

Official study title

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

Acronym: GO-INF

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Mar 26, 2014
Registry last updated
Jul 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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