Safety and Efficacy of an Infant Formula Supplemented With Galacto-oligosaccharides (GOS)
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|ClinicalTrials.gov Identifier: NCT00486148|
Recruitment Status : Completed
First Posted : June 13, 2007
Last Update Posted : March 18, 2015
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|Condition or disease||Intervention/treatment||Phase|
|Nutritional Safety||Other: Infant formula (with GOS)||Not Applicable|
Oligosaccharides are one of the major breast milk components. They are not digested and reach the colon where they're used by selected groups of microflora positive bacteria, specifically bifidobacteria and lactobacilli.
Therefore, oligosaccharides have prebiotic effects accountable for health benefits in infants.
Over the last years the supplementation of infant formulae has been studied to mimic breast milk prebiotic functions enhancing gut microflora growth similar to that of breast fed infants.
However further scientific data are necessary to support the efficacy of the supplementation of oligosaccharide in infant formulae.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||360 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Randomized, Double Blind Study to Evaluate the Safety and Efficacy of an Infant Formula Supplemented With Galacto-oligosaccharides (GOS) in Healthy, Full Term Infants|
|Study Start Date :||February 2006|
|Actual Primary Completion Date :||October 2011|
|Actual Study Completion Date :||June 2013|
No Intervention: group "S"
No Intervention: group "A"
Control Infant formula
Experimental: group "B"
Infant formula supplemented with 0.4 g/100 ml of oligosaccharides
Other: Infant formula (with GOS)
Infant formula supplemented with 0.4 g/100 ml of galacto-oligosaccharides
- The nutritional safety through anthropometric controls. Adverse events: diarrhea, crying, gaseous colics, regurgitation, vomit, skin rashes, fever. [ Time Frame: Anthropometric controls at birth, on enrolment, after 1, 2, 3, 4 months of life and just before starting weaning. Adverse events daily. ]
- The prebiotic effect through the control of the feces consistency and frequency, the incidence of gaseous colics and microbiological analyses of the fecal samples. [ Time Frame: Feces consistency and frequency, and incidence of gaseous colics, microbiological analyses of the fecal samples on enrolment and after 1 and 2 months of life. ]
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|Ages Eligible for Study:||1 Day to 15 Days (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Healthy infants of both sexes, born at term with natural labor or cesarean birth
- Single birth
- Infant born between 37th - 42th gestation week (included)
- Infant with birth weight ≥ 2500 g
- APGAR score after 5 minutes of life > 7
- Infant born from parents of Caucasian race
- Exclusive breast feeding or formula feeding within 15 days from birth.
- Consensus form signed by both parents or by the legal tutor properly informed of the study.
- Parents able to understand the protocol requirements and to fill out the infants Diary.
- Infant with inborn malformation and with hereditary and/or chronic and/or inborn diseases requiring hospital care superior to 7 days.
- Diseases jeopardizing intrauterine growth.
- Infant born from mother suffering from dismetabolic and/or chronic diseases.
- Unknown father
- Infant with parents who might not report at hospital controls or not follow the protocol.
- Infant already enrolled or selected for another clinical trial.
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): NCT00486148
|"Casa Pia Ospitaliera Uboldo" Unità Operativa di Pediatria e Neonatologia|
|Cernusco sul Naviglio (Milan), Italy, 20063|
|Ospedale "Sacra Famiglia del Fatebenefratelli" Unità Operativa di Pediatria e Neonatologia|
|Erba (Como), Italy, 22036|
|Ospedale "Santa Maria delle Stelle" Unità Operativa di Pediatria e Neonatologia|
|Melzo (MI), Italy, 20066|
|Azienda ospedaliera "San Paolo", Dipartimento di Pediatria|
|Milan, Italy, 20142|
|Ospedale "San Carlo Borromeo" Unità Operativa di Pediatria|
|Milan, Italy, 20152|
|Azienda Ospedaliera "Luigi Sacco" Unità Operativa di Pediatria|
|Milan, Italy, 20157|
|Ospedale Civile "G. da Saliceto" Unità Operativa di Pediatria|
|Piacenza, Italy, 29100|
|Principal Investigator:||Carlo Agostoni, Prof||Azienda Ospedaliera San Paolo|
|Principal Investigator:||Gian Vincenzo Zuccotti, Prof||Azienda Ospedaliera "Luigi Sacco"|
|Principal Investigator:||Giacomo Biasucci, Dr||Ospedale Civile "G. da Saliceto"|
|Principal Investigator:||Fabio Alberto Podestà, Dr||Ospedale San Carlo Borromeo|
|Principal Investigator:||Amilcare Rottoli, Dr||"Casa Pia Ospitaliera Uboldo" - Ospedale "Santa Maria delle Stelle"|
|Principal Investigator:||Cino Galluzzo, Dr||Ospedale "Sacra Famiglia del Fatebenefratelli"|
|Responsible Party:||Heinz Italia SpA|
|Other Study ID Numbers:||
|First Posted:||June 13, 2007 Key Record Dates|
|Last Update Posted:||March 18, 2015|
|Last Verified:||March 2015|