Healthy
Conditions
Brief summary
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.
Interventions
OTHERPlacebo
oral, placebo, once/day for 12 weeks
OTHERLactobacillus (Probiotic 1)
oral, Lactobacillus, once/day for 12 weeks
OTHERLactobacillus and Bifidobacterium (Probiotic 2)
oral, Lactobacillus and Bifidobacterium, once/day for 12 weeks
Sponsors
Procter and Gamble
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Years to 9 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of healthy days. | 12 weeks |
Countries
United States
Outcome results
None listed