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Digestive Tolerance of Slightly Hydrolyzed Starter Infant Formula With Probiotics

This study has been completed.
Sponsor:
Collaborator:
Chulalongkorn University
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT01036243
First received: December 17, 2009
Last updated: June 21, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention
Infant Nutrition
 Dietary Supplement: test formula 1
Dietary Supplement: test formula 2
Dietary Supplement: test formula 3
Dietary Supplement: reference formula

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Tolerance of a Slightly Hydrolyzed Starter Formula Containing Probiotics

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Nestlé:

Primary Outcome Measures:
  • incidence of crying/fussing from 1 to 3 months. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • growth and night sleep [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 480
Study Start Date: December 2009
Study Completion Date: April 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Test formula 1
Hydrolyzed formula with probiotics
 Dietary Supplement: test formula 1
hydrolyzed formula with probiotics
Other Name: 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 Name: 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 Name: 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 Name: suitable for 0-6 months of age as per standard requirement

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

Ages Eligible for Study:   up to 30 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01036243

Locations
Thailand
Chulalongkorn University
Bangkok, Thailand
Sponsors and Collaborators
Nestlé
Chulalongkorn University
Investigators
Principal Investigator: A/Prof. Boosba Vivatvakin, MD Pediatric Gastroenterology Unit,Faculty of Medicine, Chulalongkorn University
  More Information

No publications provided

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT01036243     History of Changes
Other Study ID Numbers: 07.06 INF
Study First Received: December 17, 2009
Last Updated: June 21, 2012
Health Authority: Thailand: Ethical Committee

Keywords provided by Nestlé:
digestive tolerance
night sleep
crying
growth

ClinicalTrials.gov processed this record on June 17, 2013