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Tolerance of formulas containing prebiotics in healthy, term infants
Timberly Williams1, Yong Choe, Pamela Price
1Abbott Nutrition, Columbus, OH.
Insights
Infant formula with 4 g galacto-oligosaccharides (GOS)/L showed good gastrointestinal tolerance, similar to human milk, in healthy newborns. Formula with 8 g GOS/L resulted in more watery stools compared to control formula.
Area of Science:
- Pediatrics
- Nutritional Science
- Gastroenterology
Background:
- Infant gastrointestinal tolerance is crucial for proper development.
- Galacto-oligosaccharides (GOS) are prebiotics that may influence infant gut health.
- Understanding the impact of different GOS levels in infant formula is important for optimizing infant nutrition.
Purpose of the Study:
- To compare the gastrointestinal tolerance of infant formulas with two different levels of galacto-oligosaccharides (GOS) against a control formula (CF) and human milk.
- To evaluate the effects of GOS supplementation on stool consistency and other tolerance markers in healthy term infants.
Main Methods:
- A double-blind, randomized, multicenter study involving 180 healthy, full-term infants.
- Infants were fed formula with 4 g GOS/L (EF4), 8 g GOS/L (EF8), or a control formula (CF) until 119 days of life.
- Stool consistency was assessed daily using a 5-point scale, and other tolerance parameters were recorded.
Main Results:
- The control formula group exhibited higher mean stool consistency scores compared to EF8 and human milk groups throughout the study.
- A higher percentage of watery stools was observed in the EF8 group versus the CF group during the first 14 days of life.
- The human milk group showed a significantly lower percentage of feedings with spit-up or vomiting compared to EF8 and CF groups.
Conclusions:
- Milk-based term infant formula supplemented with 4 g GOS/L demonstrated good gastrointestinal tolerance in newborns.
- Stool consistency and other tolerance measures were favorable in infants fed formula with 4 g GOS/L.
- Further research may be needed to fully elucidate the effects of higher GOS concentrations on infant tolerance.
Objective:
The aim of the study was to compare infants' gastrointestinal tolerance of formulas supplemented with 2 different levels of galacto-oligosaccharides (GOS) versus a control formula (CF) or human milk.
Methods:
Healthy, full-term infants (n = 180) were enrolled in this 3-group controlled, double-blind, multicenter study, and a concurrently enrolled, nonrandomized human milk-fed group (HM) by 8 days of age. Infants were randomized to be fed formula supplemented with either 4 g (EF4) or 8 g (EF8) GOS/L or a CF until day of life (DOL) 119. Infants were to be seen at DOL 14, 35, 56, 84, and 119. Parents were to record detailed 24-hour information about intake, tolerance to feedings, and stool patterns and consistency each day from enrollment to DOL 35, and for 3 days before DOL 56, 84, and 119. Stool consistency was scored on a 5-point scale as watery (1), loose/mushy, soft, formed, or hard (5).
Results:
The mean stool consistency score was higher in the CF group throughout the study (CF > EF8 and CF > HM for all study periods and CF > EF4 from DOL 15 to 35, P < 0.05). There was a significantly higher percentage of watery stools in the EF8 versus the CF group from study day 1 (SD 1) to DOL 14 (P < 0.05), but no differences between the groups in number of stools per day. The percentage of feedings with spit up and/or vomiting within 1 hour after feeding was significantly lower for HM versus EF8 and CF from SD 1 to DOL 14 (P < 0.05).
Conclusions:
In this clinical study, milk-based term infant formula (Similac Advance) with 4 g GOS/L was well-tolerated in terms of stool consistency and additional measures of gastrointestinal tolerance by newborn infants through the first 4 months of life.
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