2013, Number 6
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Rev Invest Clin 2013; 65 (6)
Safety of a dual potential prebiotic system from Mexican agave “Metlin® and Metlos®”, incorporated to an infant formula for term newborn babies: a randomized controlled trial
López-Velázquez G, Díaz-García L, Anzo A, Parra-Ortiz M, Llamosas-Gallardo B, Ortiz-Hernández AA, Mancilla-Ramírez J, Cruz-Rubio JM, Gutiérrez-Castrellón P
Language: English
References: 40
Page: 483-490
PDF size: 166.17 Kb.
ABSTRACT
Rationale. Infant formulae are being supplemented with
probiotics, prebiotics, or symbiotic despite uncertainties regarding
their efficacy. Mexican agave is an interesting source of
fructans with particular features and with potential prebiotic
effects.
Material and methods. RCT in 600 healthy term
babies (20 ± 7 days), allocated to receive standard infant formula
(control) or infant formula added with a dual prebiotic
system “Metlin
® and Metlos
®”, from Mexican agave. Primary
outcomes include stools frequency, stools consistency, gastrointestinal
intolerance (frequency of abdominal distension,
flatulency, regurgitations, vomiting). Secondary outcomes include
changes on weight and height along the study and frequency
of dermatologic problems (eczema).
Results. In
66,120 days of total follow-up, there were no differences on
the frequency of stools passage (Human Milk: 3.8 ± 2.4 evacuations
per day; Pro + Metlin + Metlos 3.6± 2.0; Pro + Metlin
3.6 ± 2; only Pro 3.4 ± 2.3¸ only formula 3.4 ± 2.0; p NS).
Consistency of stools was similar between human milk and
prebiotics supplemented groups. Also the frequency of gastrointestinal
symptoms was significantly low between these
groups.
Conclusions. Fructans derivate from agave and
added to infant formula are safe and well tolerated by Mexican
healthy term babies.
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