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Digestive Tolerance of Slightly Hydrolyzed Starter Infant Formula With Probiotics

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.
 
ClinicalTrials.gov Identifier: NCT01036243
Recruitment Status : Completed
First Posted : December 21, 2009
Last Update Posted : June 22, 2012
Sponsor:
Collaborator:
Chulalongkorn University
Information provided by (Responsible Party):
Société des Produits Nestlé (SPN)

Tracking Information
First Submitted Date  ICMJE December 17, 2009
First Posted Date  ICMJE December 21, 2009
Last Update Posted Date June 22, 2012
Study Start Date  ICMJE December 2009
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 18, 2009)		 incidence of crying/fussing from 1 to 3 months. [ Time Frame: 3 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 18, 2009)		 growth and night sleep [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Digestive Tolerance of Slightly Hydrolyzed Starter Infant Formula With Probiotics
Official Title  ICMJE Tolerance of a Slightly Hydrolyzed Starter Formula Containing Probiotics
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Infant Nutrition
Intervention  ICMJE
  • Dietary Supplement: test formula 1
    hydrolyzed formula with probiotics
    Other Name: for 0-6 months as per standard requirement
  • Dietary Supplement: test formula 2
    acidified hydrolyzed formula
    Other Name: suitable for 0-6 months as per standard requirement
  • Dietary Supplement: test formula 3
    hydrolyzed formula without probiotics
    Other Name: suitable for 0-6 months of age as per standard requirement
  • Dietary Supplement: reference formula
    standard infant formula
    Other Name: suitable for 0-6 months of age as per standard requirement
Study Arms  ICMJE
  • Experimental: Test formula 1
    Hydrolyzed formula with probiotics
    Intervention: Dietary Supplement: test formula 1
  • Active Comparator: test formula 2
    acidified hydrolyzed formula.
    Intervention: Dietary Supplement: test formula 2
  • Active Comparator: Test formula 3
    hydrolyzed formula without probiotics
    Intervention: Dietary Supplement: test formula 3
  • Active Comparator: reference product
    standard infant formula
    Intervention: Dietary Supplement: reference formula
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 18, 2009)		 480
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2012
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 11 Days to 30 Days   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01036243
Other Study ID Numbers  ICMJE 07.06 INF
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Société des Produits Nestlé (SPN)
Original Responsible Party A/Prof. Boosba Vivatvakin, Department of Pediatrics
Current Study Sponsor  ICMJE Société des Produits Nestlé (SPN)
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Chulalongkorn University
Investigators  ICMJE
Principal Investigator: A/Prof. Boosba Vivatvakin, MD Pediatric Gastroenterology Unit,Faculty of Medicine, Chulalongkorn University
PRS Account Société des Produits Nestlé (SPN)
Verification Date June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP