Digestive Tolerance of Slightly Hydrolyzed Starter Infant Formula With Probiotics

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.

Study Overview

• Status: Completed
• Conditions: Infant Nutrition
• Intervention / Treatment: Dietary supplement: test formula 1; Dietary supplement: test formula 2; Dietary supplement: test formula 3; Dietary supplement: reference 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.

• Study Type: Interventional
• Enrollment (Actual): 480
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand
    • Chulalongkorn University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 week to 4 weeks (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test formula 1; Hydrolyzed formula with probiotics	Dietary supplement: test formula 1; hydrolyzed formula with probiotics; Other Names: for 0-6 months as per standard requirement
Active Comparator: test formula 2; acidified hydrolyzed formula.	Dietary supplement: test formula 2; acidified hydrolyzed formula; Other Names: suitable for 0-6 months as per standard requirement
Active Comparator: Test formula 3; hydrolyzed formula without probiotics	Dietary supplement: test formula 3; hydrolyzed formula without probiotics; Other Names: suitable for 0-6 months of age as per standard requirement
Active Comparator: reference product; standard infant formula	Dietary supplement: reference formula; standard infant formula; Other Names: suitable for 0-6 months of age as per standard requirement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
incidence of crying/fussing from 1 to 3 months.	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
growth and night sleep	6 months

Collaborators and Investigators

• Sponsor: Société des Produits Nestlé (SPN)
• Collaborators: Chulalongkorn University
• Investigators: Principal Investigator: A/Prof. Boosba Vivatvakin, MD, Pediatric Gastroenterology Unit,Faculty of Medicine, Chulalongkorn University

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: December 17, 2009
• First Submitted That Met QC Criteria: December 18, 2009
• First Posted (Estimate): December 21, 2009

Study Record Updates

• Last Update Posted (Estimate): June 22, 2012
• Last Update Submitted That Met QC Criteria: June 21, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: growth; crying; digestive tolerance; night sleep
• Other Study ID Numbers: 07.06 INF