Infant Formula Supplemented With Probiotic Microorganisms and/or Prebiotic.
NCT ID: NCT00836771
Last Updated: 2013-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
270 participants
INTERVENTIONAL
2009-07-31
2014-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Materna infant formula 1
milk based infant formula powder
Infant Formula
Materna infant formula 2
Probiotic supplemented infant formula
Infant Formula
Materna infant formula 3
Prebiotic supplemented infant formula
Infant Formula
Materna infant formula 4
Prebiotic+ Probiotic supplemented infant formula
Infant Formula
Human milk
Human Milk
Infant Formula
Interventions
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Infant Formula
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
1 Day
21 Days
ALL
Yes
Sponsors
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Materna Laboratories
INDUSTRY
Responsible Party
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Principal Investigators
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Nehama Linder, M.D. Ph.D
Role: PRINCIPAL_INVESTIGATOR
Neonatology department, Rabin Medical center, Petach Tikva. Israel
Raanan Shamir, M.D. Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Institute of Gastroenterology Nutrition and Liver Diseases Schneider children medical center, Petach Tikva.
Kobi Shiff, M.D.
Role: PRINCIPAL_INVESTIGATOR
Neonatology department, Laniado Hospital- Sanz Medical Center, Netanya, Israel.
Zvi Weizman, M.D. Ph.D
Role: PRINCIPAL_INVESTIGATOR
Department of Pediatrics, Soroka University Medical Center, Beer-Sheva, Israel.
Uri Rubenstein, M.D
Role: PRINCIPAL_INVESTIGATOR
clinic, 1 Yehuda Perach St., Natanya
Locations
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Neonatology department, Laniado Hospital- Sanz Medical Center, .
Netanya, , Israel
Countries
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Other Identifiers
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80801
Identifier Type: -
Identifier Source: org_study_id
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