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OpenTrials
Completed

NCT Number: NCT01625273

Supplementation of Infant Formula With Synbiotics

The primary hypothesis is that Lactobacillus paracasei ssp. paracasei strain F19 in an infant formula containing FOS/GOS is safe and tolerable for use in infants from 0 to 6 months.

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Key information

Conditions

Infant Formula

Age range

1 day–28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samodzielny Publiczny Dziecięcy Szpital Kliniczny

Warsaw, 01-184, Poland

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • healthy infants of mothers who voluntarily resigned completely from breastfeeding
  • infant age 28 days
  • delivered between 38 and 42 weeks of gestation
  • vaginal delivery
  • birth weight > 2700 g and < 4200 g
  • parent or the subject's legal representative has to speak and understand Polish

Exclusion criteria

  • fully or partially breastfed infants
  • malformations, handicaps or congenital diseases that could affect normal growth
  • treatment with antibiotics
  • fed infant formula with pre- and/or probiotics

Treatment and study plan

Lactobacillus paracasei paracasei strain F19

Other

Provided in an infant formula, 10^8 CFU per day from 28 days to 6 months of infant age

Other names: F19

Primary outcomes

  1. Growth (body weight, length, head circumference)

    Time frame: From 28 days to 6 months

Sponsors and collaborators

Lead sponsor

Arla Foods

Industry

Registry information

Official study title

Supplementation of Infant Formula With the Synbiotics (Lactobacillus Paracasei Ssp. Paracasei Strain F19 and Fructo- and Galactooligosaccharides).

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
Jun 21, 2012
Registry last updated
Jan 26, 2017

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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