Clinical trial NCT01036243: Digestive Tolerance of Slightly Hydrolyzed Starter Infant Formula With Probiotics
Official title: Tolerance of a Slightly Hydrolyzed Starter Formula Containing Probiotics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant Nutrition
Keywords: digestive tolerance
night sleep
crying
growth
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
Collaborators: name: Chulalongkorn University
First posted: 2009-12-21
Enrollment: 480
Sex: ALL
Minimum age (years): 11
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: incidence of crying/fussing from 1 to 3 months.
timeFrame: 3 months
Secondary outcomes:
measure: growth and night sleep
timeFrame: 6 months
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Chulalongkorn University
Study officials:
affiliation: Pediatric Gastroenterology Unit,Faculty of Medicine, Chulalongkorn University
name: A/Prof. Boosba Vivatvakin, MD
role: PRINCIPAL_INVESTIGATOR
References: