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Completed

NCT Number: NCT00635388

A Study of the Effects of Probiotics in Children Grades 1-3

The primary objective of this study is to determine the appropriate study design for a full-scale claims support study to evaluate the impact of 2 probiotics on healthy days in elementary school children relative to a placebo control.

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Key information

Conditions

Healthy

Age range

5 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Research Site

Cincinnati, Ohio, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Be in good general health as reported by their parent(s)/legal guardian;
  • Be willing to refrain from ingesting any product that contains fermented live bacteria (other than their test product) during the study as confirmed by their parent(s)/legal guardian(s);
  • Be willing to continue their current dietary habits for the duration of the study as confirmed by their parent(s)/legal guardian(s)

Exclusion criteria

  • Have a known hypersensitivity or allergy to any product ingredient to be ingested during the study, as reported by their parent(s)/legal guardian(s)

Treatment and study plan

Placebo

Other

oral, placebo, once/day for 12 weeks

Lactobacillus (Probiotic 1)

Other

oral, Lactobacillus, once/day for 12 weeks

Lactobacillus and Bifidobacterium (Probiotic 2)

Other

oral, Lactobacillus and Bifidobacterium, once/day for 12 weeks

Primary outcomes

  1. Number of healthy days.

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Procter and Gamble

Industry

Registry information

Official study title

A Double-blind, Randomized, Placebo-controlled Study of the Effects of Probiotics in Children Grades 1-3

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Mar 13, 2008
Registry last updated
Oct 16, 2009

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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