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Infant Formula Supplemented With Probiotic Microorganisms and/or Prebiotic.

This study is currently recruiting participants.
Verified May 2012 by Materna Laboratories
Sponsor:
Information provided by (Responsible Party):
Materna Laboratories
ClinicalTrials.gov Identifier:
NCT00836771
First received: February 3, 2009
Last updated: April 23, 2013
Last verified: May 2012
History of Changes

February 3, 2009
April 23, 2013
July 2009
January 2014   (final data collection date for primary outcome measure)
weight gain [ Time Frame: 1 to 120 days of age ] [ Designated as safety issue: Yes ]
  • anthropometric musures [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
  • anthropometric (weight, length and head circumferences [ Time Frame: 16 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00836771 on ClinicalTrials.gov Archive Site
  • Anthropometric [ Time Frame: 1-120 days of age ] [ Designated as safety issue: Yes ]
  • GI tolerance [ Time Frame: 1-120 days of age ] [ Designated as safety issue: Yes ]
microbiology [ Time Frame: 16 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Infant Formula Supplemented With Probiotic Microorganisms and/or Prebiotic.
Evaluation of the Effect of Milk Based Infant Formula Supplemented Either With Probiotic Microorganisms and/or With Prebiotic on the Intestinal Microflora During the First 4 Months of Life of Healthy, Full Term Infants and it's Long Term Effect on Morbidity up to the Age of 9 Months

Evaluation the nutritional suitability of a based milk infant formula supplemented with friendly bacteria (probiotic microorganisms) and or nutritional fibers (prebiotic) to healthy, full term infants compare with an otherwise identical widely used commercially available milk based infant formula and/or breast feed
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Effect of Probiotic on Morbidity
Dietary Supplement: probiotic microorganism and/or prebiotic
Milk based infant formula supplemented with either probiotic microorganisms and/or prebiotic
  • Placebo Comparator: milk based infant formula powder
    Intervention: Dietary Supplement: probiotic microorganism and/or prebiotic
  • Experimental: investigational infant formula #1
    Probiotic supplementation
    Intervention: Dietary Supplement: probiotic microorganism and/or prebiotic
  • Experimental: investigational infant formula #2
    Prebiotic supplementation
    Intervention: Dietary Supplement: probiotic microorganism and/or prebiotic
  • Experimental: investigational infant formula #3
    Prebiotic+ Probiotic supplementation
    Intervention: Dietary Supplement: probiotic microorganism and/or prebiotic
  • Human milk
    Intervention: Dietary Supplement: probiotic microorganism and/or prebiotic
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
270
December 2014
January 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy term infants of both sexes, born in natural labor .
  • Single birth.
  • Full term infants (born between the 37th and 42nd week of gestation)
  • Infants with birth weight >2500 g.
  • Recruitment age will be 0-21 days.
  • Infants whose mothers are unable to breast feed or have chosen not to breast feed prior to the study enrollment.
  • Infants whose parents have agreed to participate in the study up to the age of 9 months..
  • Infants whose parents have agreed to remain exclusively on the same product for 16 weeks of age..
  • Infants whose parents have signed the informed consent form.
  • Infants whose parents are able to understand the protocol requirements and to fill out the infant's diary and agree to completely fill out the parents' questionnaires during the period Of 9 months

Exclusion Criteria:

  • Twins.
  • Premature or low birth weight (< 2500 g).
  • Chromosomal abnormalities or congenital malformation.
  • Suffering jaundice which require phototherapy.
  • Proven or suspected family history of allergy to cow's milk.
  • Having been treated with antibiotics or other drugs during the last three days or more prior to the commencement of the study.
Both
up to 21 Days
Yes
Not Provided
Israel
 
NCT00836771
80801
Yes
Materna Laboratories
Materna Laboratories
Not Provided
Principal Investigator: Nehama Linder, M.D. Ph.D Neonatology department, Rabin Medical center, Petach Tikva. Israel
Principal Investigator: Raanan Shamir, M.D. Ph.D. Institute of Gastroenterology Nutrition and Liver Diseases Schneider children medical center, Petach Tikva.
Principal Investigator: Kobi Shiff, M.D. Neonatology department, Laniado Hospital- Sanz Medical Center, Netanya, Israel.
Principal Investigator: Zvi Weizman, M.D. Ph.D Department of Pediatrics, Soroka University Medical Center, Beer-Sheva, Israel.
Principal Investigator: Uri Rubenstein, M.D clinic, 1 Yehuda Perach St., Natanya
Materna Laboratories
May 2012

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