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
|Condition or disease||Intervention/treatment||Phase|
|Gastrointestinal Diseases||Dietary Supplement: Infant Formula with a novel probiotic CECT7210 Dietary Supplement: Standard formula||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||194 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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
- Changes in diarrhea incidence [ Time Frame: At 4th, 8th, 12th weeks ]Differences between diarrhea incidence amongst groups from baseline to 12th weeks.
- Changes in infections incidence [ Time Frame: At 4th, 8th, 12th weeks. ]Differences between rate of infections or duration amongst groups.
- Changes in microbiota [ Time Frame: At 4th, 8th, 12th weeks ]Differences between faecal bacterial populations.
- Changes in Immunoglobulin A secretor (IgAs) [ Time Frame: At 4th and 12th weeks ]Differences between faecal IgAs amongst groups.
- Tolerability of the product [ Time Frame: At 4th, 8th and 12th weeks ]To evaluate gastrointestinal tolerability of both study formulas.
- Growth [ Time Frame: At 4th, 8th and 12th weeks ]To compare anthropometric measurements between probiotic CECT7210 formula group and standard group.
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
|Hospital Sant Joan de Reus|
|Reus, Tarragona, Spain|
|Hospital Universitario La Paz|
|Hospital Joan XXIII|
|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|