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

Procter and Gamble360 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

QUADRUPLE

Enrollment

360

Conditions

Healthy

Interventions

PlaceboOTHER

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

Eligibility

Sex: ALLMin age: 5 YearsMax age: 9 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Research Site

Cincinnati, Ohio, United States

Outcomes

Primary Outcomes

Number of healthy days.

Time frame: 12 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.