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Completed

NCT Number: NCT01755481

Feeding Infant Formula With Added Probiotics and Whey Protein Concentrate

To evaluate the effects of feeding an infant formula containing L. paracasei ssp. paracasei strain F19 or Whey Protein Concentrate.

Completed

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Key information

Conditions

Focus on Healthy Infants

Age range

Up to 2 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Child Health Care, Children's Hospital, Fudan University

Shanghai, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(formula-fed group):

healthy infants of mothers who could not or voluntarily resigned completely from breast-feeding at infant age 14 plus/minus 3 days

Inclusion criteria

(breast-fed group):

healthy infants exclusively breast-fed from birth and mothers intending to breastfeed >80% until at least 5th month of age (meaning through the 4th month of age).

Inclusion criteria

(all infants):

delivered between 37 and 42 weeks of gestation birth weight >2500 g and <4000 g parent or the subject's legal representative speak and understand Chinese

Exclusion criteria

(formula-fed group):

fully or partially breast-fed infants infants breast-fed >20%

Exclusion criteria

(breast-fed group):

infants fed >20% infant formula

Exclusion criteria

(all infants):

malformations, handicaps or congenital diseases that could affect normal feeding or growth treatment with antibiotics

Treatment and study plan

Probiotic

Other

Whey protein concentrate

Other

Primary outcomes

  1. Infections episodes (gastrointestinal and upper and lower respiratory infections)

    Time frame: 4 yrs

Sponsors and collaborators

Lead sponsor

Arla Foods

Industry

Registry information

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Dec 24, 2012
Registry last updated
Jan 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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