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

Study Overview

• Status: Unknown
• Conditions: Focus on Healthy Infant Growth.
• Intervention / Treatment: Dietary supplement: Infant Formula

• Study Type: Interventional
• Enrollment (Anticipated): 270
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Netanya,, Israel
    • Neonatology department, Laniado Hospital- Sanz Medical Center, .

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 3 weeks (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Materna infant formula 1; milk based infant formula powder	Dietary supplement: Infant Formula; Other Names: Materna
Experimental: Materna infant formula 2; Probiotic supplemented infant formula	Dietary supplement: Infant Formula; Other Names: Materna
Experimental: Materna infant formula 3; Prebiotic supplemented infant formula	Dietary supplement: Infant Formula; Other Names: Materna
Experimental: Materna infant formula 4; Prebiotic+ Probiotic supplemented infant formula	Dietary supplement: Infant Formula; Other Names: Materna
Other: Human milk; Human Milk	Dietary supplement: Infant Formula; Other Names: Materna

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
weight gain	1 to 120 days of age

Secondary Outcome Measures

Outcome Measure	Time Frame
Anthropometric	1-120 days of age
GI tolerance	1-120 days of age

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Influence on the microbial content of the stool	Stool were collected to analyze the microbial content of certain bacteria upon enrollment and at the age of 4, 16. and 36 w Stool were collected and delivery to the lab in coolers within 12 h	3 - 4 times: 1-16 d, 4 w 16 w and 36 w

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Anticipated): January 1, 2014
• Study Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: February 3, 2009
• First Submitted That Met QC Criteria: February 3, 2009
• First Posted (Estimate): February 4, 2009

Study Record Updates

• Last Update Posted (Estimate): July 31, 2013
• Last Update Submitted That Met QC Criteria: July 30, 2013
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: Infant formula; Probiotic microorganisms; prebiotic
• Other Study ID Numbers: 80801

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No