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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
  Purpose

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


Condition Intervention
Effect of Probiotic on Morbidity
 Dietary Supplement: probiotic microorganism and/or prebiotic

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Materna Laboratories:

Primary Outcome Measures:
  • weight gain [ Time Frame: 1 to 120 days of age ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 270
Study Start Date: July 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: milk based infant formula powder Dietary Supplement: probiotic microorganism and/or prebiotic
Milk based infant formula supplemented with either probiotic microorganisms and/or prebiotic
Experimental: investigational infant formula #1
Probiotic supplementation
 Dietary Supplement: probiotic microorganism and/or prebiotic
Milk based infant formula supplemented with either probiotic microorganisms and/or prebiotic
Experimental: investigational infant formula #2
Prebiotic supplementation
 Dietary Supplement: probiotic microorganism and/or prebiotic
Milk based infant formula supplemented with either probiotic microorganisms and/or prebiotic
Experimental: investigational infant formula #3
Prebiotic+ Probiotic supplementation
 Dietary Supplement: probiotic microorganism and/or prebiotic
Milk based infant formula supplemented with either probiotic microorganisms and/or prebiotic
Human milk Dietary Supplement: probiotic microorganism and/or prebiotic
Milk based infant formula supplemented with either probiotic microorganisms and/or prebiotic

  Eligibility

Ages Eligible for Study:   up to 21 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00836771

Locations
Israel
Neonatology department, Laniado Hospital- Sanz Medical Center, . Recruiting
Netanya,, Israel
Contact: Kobi, Shiff, MD     0522837476        
Sponsors and Collaborators
Materna Laboratories
Investigators
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
  More Information

No publications provided

Responsible Party: Materna Laboratories
ClinicalTrials.gov Identifier: NCT00836771     History of Changes
Other Study ID Numbers: 80801
Study First Received: February 3, 2009
Last Updated: April 23, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Materna Laboratories:
Infant formula
Probiotic microorganisms
prebiotic

ClinicalTrials.gov processed this record on June 18, 2013