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OpenTrials
Completed

NCT Number: NCT01215656

Effect of a Follow on Formula With Lactobacillus Fermentum on the Incidence of Infections

The objective of the study is to evaluate the effects of a follow on formula containing the human milk probiotic Lactobacillus fermentum on the incidence of infection in 6 months old infants.

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Key information

Conditions

Incidence of Infectious Diseases

Age range

6 month–7 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 6 months old children born at term
  • written consent from parents

Exclusion criteria

  • frequent gastrointestinal disorders (frequent diarrhoeas, constipation episodes, gastroesophageal reflux)
  • gastrointestinal surgery
  • cow's milk protein allergy
  • metabolic diseases (diabetes or lactose intolerance)
  • immune deficiency
  • antibiotic treatment during the trial and/or recent (within the preceding 3 weeks)

Treatment and study plan

Lactobacillus fermentum

Dietary Supplement

Follow on formula without probiotics

Dietary Supplement

Primary outcomes

  1. Incidence of infectious diseases

Sponsors and collaborators

Lead sponsor

Puleva Biotech

Industry

Registry information

Important dates

Study start
2008
Primary completion
2010
First posted
Oct 6, 2010
Registry last updated
Oct 7, 2010

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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