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Digestive Tolerance of Slightly Hydrolyzed Starter Infant Formula With Probiotics

Sponsor
Nestlé (Industry)
Overall Status
Completed
CT.gov ID
NCT01036243
Collaborator
Chulalongkorn University (Other)
480
Enrollment
1
Location
4
Arms
28
Duration (Months)
17.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: test formula 1
  • Dietary Supplement: test formula 2
  • Dietary Supplement: test formula 3
  • Dietary Supplement: reference formula
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
480 participants
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
Study Start Date :
Dec 1, 2009
Actual Primary Completion Date :
Jan 1, 2012
Actual Study Completion Date :
Apr 1, 2012

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. incidence of crying/fussing from 1 to 3 months. [3 months]

    Secondary Outcome Measures

    1. growth and night sleep [6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    11 Days to 30 Days
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nestlé
    ClinicalTrials.gov Identifier:
    NCT01036243
    Other Study ID Numbers:
    • 07.06 INF
    First Posted:
    Dec 21, 2009
    Last Update Posted:
    Jun 22, 2012
    Last Verified:
    Jun 1, 2012
    Keywords provided by Nestlé
    digestive tolerance
    night sleep
    crying
    growth

    Study Results

    No Results Posted as of Jun 22, 2012