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Study Title and Description

Tolerance and safety evaluation in a large cohort of healthy infants fed an innovative prebiotic formula: a randomized controlled trial.



Key Questions Addressed
1 Is this an intervention study?
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Primary Publication Information
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TitleData
Title Tolerance and safety evaluation in a large cohort of healthy infants fed an innovative prebiotic formula: a randomized controlled trial.
Author Piemontese P., Giannì ML., Braegger CP., Chirico G., GrĂ¼ber C., Riedler J., Arslanoglu S., van Stuijvenberg M., Boehm G., Jelinek J., Roggero P.
Country Department of Maternal and Pediatric Sciences, Fondazione IRCCS ''Ca'Granda'' Ospedale Maggiore Policlinico, University of Milan, Milano, Italy.
Year 2011
Numbers Pubmed ID: 22140499

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 2011
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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 Food partially provided (partial metabolic study)
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sampsize 1130
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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 ~36 days
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age_range < 8 weeks
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bmi_mean NR
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bmi_range
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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 ~49
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ftype1 Combination/Mixture
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descrip1_1 scGOS/lcFOS
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descrip1_2 pectin acidic-oligosaccharides
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dose1_1 6.8 g/L
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dose1_2 1.2 g/L
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duration1 1 year
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admin1 Powder
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ftype2
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descrip2_1
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descrip2_2
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dose2_1
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dose2_2
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duration2
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admin2
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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 control
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cdose1 0
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cduration1 1 year
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cadmin1 Powder
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comparator2 breast-fed group
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cdose2
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cduration2 1 year
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cadmin2 Diet
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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.