Digestive Tolerance of Slightly Hydrolyzed Starter Infant Formula With Probiotics

Nestlé

Status: Completed

Conditions: Infant Nutrition

Treatments: Dietary Supplement: reference formula; Dietary Supplement: test formula 2; Dietary Supplement: test formula 1; Dietary Supplement: test formula 3

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01036243

07.06 INF

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 480 patients

Sex: All

Ages: 11 to 30 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy infants, 0-1 month old at point of enrollment
• Birth weight < 2500g and > 4500g
• Gestational age < 37 weeks and > 42 weeks
• Infants who cannot be breastfed because of the maternal status
• Willing to exclusively consume the assigned study formula with whey protein
• Are likely to be compliant
• Mother/caregiver demonstrates an understanding of the given information and ability to record the requested data

Exclusion criteria

• Congenital illness or malformation
• Significant pre-natal and/or post-natal disease
• Receiving systemic antibiotic treatment at time of enrolment
• Infant with symptoms of allergy to cow's milk
• Infant's family cannot be expected to comply with treatment (feeding regimen)
• Subjects who cannot be expected to comply with treatment
• Currently participating or having participated in another clinical trial during the last month

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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480 participants in 4 patient groups

Test formula 1

Experimental group

Description:

Hydrolyzed formula with probiotics

Treatment:

Dietary Supplement: test formula 1

test formula 2

Active Comparator group

Description:

acidified hydrolyzed formula.

Treatment:

Dietary Supplement: test formula 2

Test formula 3

Active Comparator group

Description:

hydrolyzed formula without probiotics

Treatment:

Dietary Supplement: test formula 3

reference product

Active Comparator group

Description:

standard infant formula

Treatment:

Dietary Supplement: reference formula