[Literature library] High sn-2 palmitate infant formula and gastrointestinal (GI) tolerance

Study Design

• Multicenter, open-label, observational study of healthy-term infants aged between 2 and 12 weeks in the Kingdom of Saudi Arabia (KSA) and the United Arab Emirates (UAE)
   

Subjects

• Healthy-term infants (n = 227) prescribed a high sn-2 palmitate infant formula and received at least 2 feedings per day for the past 2 weeks prior to the study
   

Study Duration and Key Measurements

• From baseline to 12 weeks after enrollment  
• Clinic visits were conducted at enrollment, weeks 4 and 12
• Parents were trained to fill the Amsterdam stool form scale and a diary
   

Results

Stool characteristics (baseline versus week 12),

• The median number of stools per day reduced from 4 to 3 (p = 0.015)
• The percentage of hard stool decreased from 17.4% to 0.4% (p < 0.001)
• Infants tended to have a higher stool amount at the end
  • At baseline, 56.5% of the infants had a stool amount of 25-50% of the diaper, while 16.3% had a stool amount of 25% of the diaper
  • At week 12, 61.2% of the infants had a stool amount of 25-50% of the diaper, while 33.7% had a stool amount greater than 50% of the diaper
• Percentages of pale yellow, green, and black stools declined (p < 0.001)
   

GI symptoms (baseline versus week 12),

• Incidence of colic and abdominal distension declined from 21.4% and 39.9% to 2.9% and 9.4% respectively (p < 0.05)
• Improved regurgitation score
  • The percentage of infants without regurgitation changed from 54.7% at baseline to 83.7% at week 12 (p < 0.05)
     

Growth parameter (baseline versus week 12),

• Weight, hip/waist ratio and head circumference increased significantly
   

Safety,

• Well tolerated with a low rate of adverse effects
   

Acceptability of parents and pediatricians,

• Most parents and pediatricians rated good-to-excellent tolerability
   

Conclusion

• Infant formula with a high sn-2 palmitate content may help with GI tolerance and stool characteristics in formula-fed infants
• It is tolerable and safe for non-breastfed healthy infants
   

Link to the full article:
https://www.mdpi.com/2036-7503/13/4/76/html
 

Reference:

Possner M et al. Acceptability of “high sn-2” infant formula in non-breast fed healthy term infants regarding gastrointestinal tolerability by both parents and pediatrician: an open-label pilot study in the Gulf Cooperation Council (GCC) countries. Pediatric Reports. 2021; 13(4):639-649.
 

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High sn-2 palmitate formula and neurodevelopmental outcomes in term infants
 

WYE-EM-215-DEC-21