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Digestive Tolerance of Slightly Hydrolyzed Starter Infant Formula With Probiotics

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01036243
First Posted: December 21, 2009
Last Update Posted: June 22, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Chulalongkorn University
Information provided by (Responsible Party):
Nestlé
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Tolerance of a Slightly Hydrolyzed Starter Formula Containing Probiotics

Resource links provided by NLM:


Further study details as provided by Nestlé:

Primary Outcome Measures:
  • incidence of crying/fussing from 1 to 3 months. [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • growth and night sleep [ Time Frame: 6 months ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 30 Days   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT01036243     History of Changes
Other Study ID Numbers: 07.06 INF
First Submitted: December 17, 2009
First Posted: December 21, 2009
Last Update Posted: June 22, 2012
Last Verified: June 2012

Keywords provided by Nestlé:
digestive tolerance
night sleep
crying
growth