Clinical trial NCT00836771: Infant Formula Supplemented With Probiotic Microorganisms and/or Prebiotic.
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Focus on Healthy Infant Growth.
Keywords: Infant formula
Probiotic microorganisms
prebiotic
Lead sponsor: Materna Laboratories
Sponsor class: INDUSTRY
First posted: 2009-02-04
Enrollment: 270
Sex: ALL
Minimum age (years): 1
Maximum age (years): 21
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility 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.

Primary outcomes:
measure: weight gain
timeFrame: 1 to 120 days of age
Secondary outcomes:
measure: Anthropometric
timeFrame: 1-120 days of age
measure: GI tolerance
timeFrame: 1-120 days of age
Other outcomes:
measure: Influence on the microbial content of the stool
timeFrame: 3 - 4 times: 1-16 d, 4 w 16 w and 36 w
Locations:
city: Netanya,
country: Israel
facility: Neonatology department, Laniado Hospital- Sanz Medical Center, .
Study officials:
affiliation: Neonatology department, Rabin Medical center, Petach Tikva. Israel
name: Nehama Linder, M.D. Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Gastroenterology Nutrition and Liver Diseases Schneider children medical center, Petach Tikva.
name: Raanan Shamir, M.D. Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Neonatology department, Laniado Hospital- Sanz Medical Center, Netanya, Israel.
name: Kobi Shiff, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Pediatrics, Soroka University Medical Center, Beer-Sheva, Israel.
name: Zvi Weizman, M.D. Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: clinic, 1 Yehuda Perach St., Natanya
name: Uri Rubenstein, M.D
role: PRINCIPAL_INVESTIGATOR
References: