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

This study has been completed.
Sponsor:
Information provided by:
Procter and Gamble
ClinicalTrials.gov Identifier:
NCT00635388
First received: February 19, 2008
Last updated: October 15, 2009
Last verified: October 2009

February 19, 2008
October 15, 2009
February 2008
May 2008   (final data collection date for primary outcome measure)
Number of healthy days. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00635388 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Study of the Effects of Probiotics in Children Grades 1-3
A Double-blind, Randomized, Placebo-controlled 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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Healthy
  • Other: Placebo
    oral, placebo, once/day for 12 weeks
  • Other: Lactobacillus (Probiotic 1)
    oral, Lactobacillus, once/day for 12 weeks
  • Other: Lactobacillus and Bifidobacterium (Probiotic 2)
    oral, Lactobacillus and Bifidobacterium, once/day for 12 weeks
  • Sham Comparator: 1
    Intervention: Other: Placebo
  • Experimental: 2
    Intervention: Other: Lactobacillus (Probiotic 1)
  • Experimental: 3
    Intervention: Other: Lactobacillus and Bifidobacterium (Probiotic 2)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
360
May 2008
May 2008   (final data collection date for primary outcome measure)

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)
Both
5 Years to 9 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00635388
2007149
No
Carl J Eastwood, Procter & Gamble
Procter and Gamble
Not Provided
Principal Investigator: Carl J Eastwood, MS Procter and Gamble
Procter and Gamble
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP