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Completed

NCT Number: NCT00599430

Evaluation of Probiotics on Symptoms of Upper Respiratory Tract Infections

The aim of the present prospective study is to investigate whether the consumption of certain probiotic strains over a six-month winter/spring season would be able to affect the incidence and duration of upper respiratory tract infections, in otherwise healthy children as well as determining whether a combination of two strains would perform differently from a single strain version.

Completed

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Key information

Conditions

Healthy

Age range

3 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Day care center

Jinhua, Zhejiang, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Children aged 3-5 years of normal nutritional status and health

Exclusion criteria

  • Contraindications to dairy products (lactose intolerance or cow's milk allergy)
  • Indicators of inflammatory disease, intestinal disease, Crohn's disease, colitis, celiac disease
  • Chronic cough from recurring respiratory distress-related diseases
  • Hirschsprung's disease
  • Cystic fibrosis
  • Other metabolic, neurological, or anatomic alteration that predisposes participation
  • Intake of probiotics within the last 3 weeks

Treatment and study plan

Placebo

Dietary Supplement

Inert excipient

Lactobacillus acidophilus NCFM

Dietary Supplement

1e10 CFU/day

Combination of Lactobacillus acidophilus and Bifidobacterium lactis

Dietary Supplement

1x10e10 CFU/day

Primary outcomes

  1. To examine if the consumption of two different probiotic strains added to milk at the point of consumption could reduce the "flu-like" symptoms and other symptoms of illness of preschool-age children in day care centers.

    Time frame: Daily for six months

Secondary outcomes

  1. To determine if children who consume a beverage fortified with a probiotic miss fewer days of preschool as measured by illness.

    Time frame: Six months

Sponsors and collaborators

Lead sponsor

Danisco

Industry

Registry information

Official study title

Probiotics and Effects on Illness-Related Symptoms for Pre-School Age Children

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Jan 23, 2008
Registry last updated
Jan 23, 2008

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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