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Study Title and Description

Growth and safety evaluation of infant formulae containing oligosaccharides derived from bovine milk: a randomized, double-blind, noninferiority trial.



Key Questions Addressed
1 Is this an intervention study?
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Primary Publication Information
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TitleData
Title Growth and safety evaluation of infant formulae containing oligosaccharides derived from bovine milk: a randomized, double-blind, noninferiority trial.
Author Meli F., Puccio G., Cajozzo C., Ricottone GL., Pecquet S., Sprenger N., Steenhout P.
Country Dipartimento Materno Infantile, Unità Operativa di Neonatologia, Università degli Studi di Palermo, Palermo, Italy. meliferd@libero.it.
Year 2014
Numbers Pubmed ID: 25527244

Secondary Publication Information
There are currently no secondary publications defined for this study.


Extraction Form: Fiber 4.1
Arms
No arms have been defined in this extraction form.

Design Details
Question... Follow Up Answer Follow-up Answer
pubyear 2014
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country Italy
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design Randomized Controlled Trial (parallel)
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blindness Double blind
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diet Isocaloric/Maintenance
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feedcontrol All food provided (metabolic study)
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sampsize 281
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runin No
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washout Not applicable
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dosechange No
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age_adult
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age_adol
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age_child
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age_baby
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age_infant 1
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age_oth
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age_mean (at baseline) 4.5 days control group, 5.4 days BMOS group, 5.0 days BMOS+probiotic group
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age_range NR
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bmi_mean NR
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bmi_range NR
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blhealth_healthy 1
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blhealth_hyperlip
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blhealth_diab
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blhealth_hyperten
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blhealth_digest
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blhealth_met
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blhealth_oth
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blhealth_othspec
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gender 60.7% control group, 54.5% BMOS group, 57.1% BMOS+probiotic group
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ftype1 Oligosaccharide (derived from bovine milk)
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descrip1_1
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descrip1_2
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dose1_1 7.3g/100g of powder formula; 10g/L in reconstituted formula
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dose1_2
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duration1 ~4 months
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admin1 Beverage
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ftype2 Oligosaccharide (derived from bovine milk) + probiotics
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descrip2_1
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descrip2_2
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dose2_1 BMOS: 7.3g/100g of powder formula; 10g/L in reconstituted formula
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dose2_2
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duration2 ~4 months
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admin2 Beverage
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ftype3
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descrip3_1
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descrip3_2
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dose3_1
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dose3_2
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duration3
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admin3
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ftype4
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descrip4_1
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descrip4_2
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dose4_1
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dose4_2
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duration4
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admin4
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comparator1 whey-based infant formula
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cdose1 NR
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cduration1 ~4 months
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cadmin1 Beverage
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comparator2
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cdose2
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cduration2
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cadmin2
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comparator3
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cdose3
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cduration3
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cadmin3
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comparator4
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cdose4
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cduration4
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cadmin4
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Baseline Characteristics
No baseline characteristics have been defined for this extraction form.



Results & Comparisons

No Results found.
Adverse Events
Arm or Total Title Description Comments

Quality Dimensions
No quality dimensions were specified.

Quality Rating
No quality rating data was found.