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OpenTrials
Completed

NCT Number: NCT01346644

Safety of Lactobacillus Fermentum in Newborn Infants

In the last years manipulation of intestinal microbiota with probiotics has gained an increasing interest, specially in infant nutrition since recent studies has demonstrated the presence of probiotics in human milk. However, there are few studies studying the effects of probiotics in newborns. The objective of the present study is to analyze safety and tolerance of the probiotic Lactobacillus fermentum CECT5716 isolated from human milk.

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Key information

Conditions

Tolerance Infections

Age range

21 day–30 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Biosearch Life

Granada, 18004, Spain

Who can participate

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

Inclusion criteria

  • Healthy 1 month infants exclusively formula-fed

Exclusion criteria

  • gastrointestinal disorders (history of chronic diarrhoea or constipation, gastroesophageal reflux)
  • gastrointestinal surgery
  • cow's milk protein allergy
  • metabolic disorders (diabetes, lactose intolerance)
  • immune deficiency
  • antibiotic prescription 1-week prior to inclusion and previous use of formula containing prebiotics or probiotics

Treatment and study plan

Infant Formula

Other

Powder infant formula

Primary outcomes

  1. average weight gain

    Time frame: 4 months

Secondary outcomes

  1. growth and health of infants

    Time frame: 2,4,6,12 and 36 months of life

    average weight, length of infants. Incidence of infections. Incidence of allergic diseases

Sponsors and collaborators

Lead sponsor

Puleva Biotech

Industry

Registry information

Official study title

Study of Tolerance of an Infant Formula Supplemented With Lactobacillus Fermentum CECT5716

Important dates

Study start
2009
First posted
May 3, 2011
Registry last updated
May 16, 2013

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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