Infant Nutrition Clinical Trial
Official title:
Tolerance of a Slightly Hydrolyzed Starter Formula Containing Probiotics
To demonstrate that infants have improved gut comfort when fed a slightly hydrolyzed starter formula containing probiotics compared to infants fed a control hydrolyzed and referenced non-hydrolyzed formula.
Infants often experience undesirable gastrointestinal effects, such as constipation,
flatulence. These symptoms are often perceived by the parents as being related to the diet
(formula) the baby is consuming. In another hand, infantile colic or fussing/crying is one
of the most commonly encountered problems within the first three months of life. The
etiology of the disorder remains unknown however, three main theories have been proposed to
explain its origin: (i) psychological: due to inadequate mother-infant interaction (ii)
gastrointestinal: such as hypertonicity and immaturity of the GI tract and Dietary factors
that may influence the stool pattern in formula fed infants are (iii) allergic: due to a
reaction against cow's milk protein or other food constituents. e.g. the protein source, the
iron content, hydrolyzation of the protein, or the fat source.
It has been reported that infants receiving a casein predominant formula had less unformed
stools than those receiving a whey predominant formula. Hydrolysation of protein resulted in
reduced gastro-intestinal transit time and some studies using extensively hydrolyzed protein
formula have shown more liquid stools.
A reduction of crying hours was also described in infant receiving an hydrolyzed formula.
Some probiotics were reported with potential benefit on the gut comfort.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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