An interventional study of Infant Formula with a novel probiotic CECT7210 and Standard formula in Gastrointestinal Diseases, sponsored by Laboratorios Ordesa. Completed at 3 sites in Spain. Open to participants aged Up to 90 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-19.
Sponsored by Laboratorios Ordesa · Not applicable, Interventional, and Prevention
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.
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.
628 studies on the registry are indexed under Gastrointestinal Diseases; 129 are open to participants now.
This study's enrollment of 194 is above the median of 77 across 422 interventional studies indexed under Gastrointestinal Diseases.
Browse Gastrointestinal Diseases studies →Laboratorios Ordesa is the lead sponsor of 16 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Infant formula with a novel probiotic CECT7210
Dietary Supplement: Infant Formula with a novel probiotic CECT7210
Standard infant formula without probiotics
Dietary Supplement: Standard formula
Bottle-feeding with a new infant formula enriched with probiotic CECT7210 during the first 3 months of life.
Standard formula without probiotics
Changes in diarrhea incidence
Differences between diarrhea incidence amongst groups from baseline to 12th weeks.
Time frame: At 4th, 8th, 12th weeks
Changes in infections incidence
Differences between rate of infections or duration amongst groups.
Time frame: At 4th, 8th, 12th weeks.
Changes in microbiota
Differences between faecal bacterial populations.
Time frame: At 4th, 8th, 12th weeks
Changes in Immunoglobulin A secretor (IgAs)
Differences between faecal IgAs amongst groups.
Time frame: At 4th and 12th weeks
Tolerability of the product
To evaluate gastrointestinal tolerability of both study formulas.
Time frame: At 4th, 8th and 12th weeks
Growth
To compare anthropometric measurements between probiotic CECT7210 formula group and standard group.
Time frame: At 4th, 8th and 12th weeks
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Laboratorios Ordesa