This trial is active, not recruiting.

Condition focus on healthy infant growth.
Treatment infant formula
Sponsor Materna Laboratories
Start date July 2009
End date January 2014
Trial size 270 participants
Trial identifier NCT00836771, 80801


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
(Placebo Comparator)
milk based infant formula powder
infant formula Materna
Probiotic supplemented infant formula
infant formula Materna
Prebiotic supplemented infant formula
infant formula Materna
Prebiotic+ Probiotic supplemented infant formula
infant formula Materna
Human Milk
infant formula Materna

Primary Outcomes

weight gain
time frame: 1 to 120 days of age

Secondary Outcomes

time frame: 1-120 days of age
GI tolerance
time frame: 1-120 days of age

Eligibility Criteria

Male or female participants up to 21 days old.

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.

Additional Information

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
Principal investigator Nehama Linder, M.D. Ph.D
Trial information was received from ClinicalTrials.gov and was last updated in July 2013.
Information provided to ClinicalTrials.gov by Materna Laboratories.