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

Procter & Gamble (P&G)

Status: Completed

Conditions: Healthy

Treatments: Other: Lactobacillus and Bifidobacterium (Probiotic 2); Other: Placebo; Other: Lactobacillus (Probiotic 1)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00635388

2007149

Details and patient eligibility

About

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.

Enrollment: 360 patients

Sex: All

Ages: 5 to 9 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

360 participants in 3 patient groups

1

Sham Comparator group

Treatment:

Other: Placebo

2

Experimental group

Treatment:

Other: Lactobacillus (Probiotic 1)

3

Experimental group

Treatment:

Other: Lactobacillus and Bifidobacterium (Probiotic 2)