Decreasing Rates of Illness in Kids (DRINK)

• Status: Completed
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the effectiveness of a cultured dairy drink with high concentrations of active L casei to reduce the cumulative rate of illness in daycare/school children ages 3 to 6.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Georgetown University
• Collaborator: Dannon Company, Inc.

Criteria

Inclusion Criteria:

• Male or female

• Aged 3 to 6 years

• Attending daycare centers or school 5 days a week

• Subjects or parents/legal guardians who agree to have their child refrain from consuming dairy fermented products during the course of the study

Exclusion Criteria:

• Subjects whose caregivers do not speak English or Spanish

• Subjects with allergy or hypersensitivity to milk proteins or dairy food components like lactose

• Subjects that do not have proper storage facility for product to be held at home

• Subjects presenting with a chronic disease that requires daily medication (Ex. cancer, tuberculosis, Crohns disease, cirrhosis, multiple sclerosis, Type 1 Diabetes...)

• Subjects with cardiac, respiratory, or renal insufficiencies

• Subjects with chronic immunodeficiency (ex: HIV, Chemotherapy...)

• Subjects presenting any infection in the last 7 days

• Subjects with any current or past severe gastrointestinal or metabolic disease (malabsorption, ulcer, celiac disease...)

• Subjects with a history of severe respiratory disease that requires daily usage of medicine

• Subjects that used laxatives in the last 7 days

• Subjects currently with diarrhea or constipation in the last 7 days

• Subjects under artificial nutrition or that were under artificial nutrition in the last 2 months

• Subjects with special medicated diet (obesity, anorexia, metabolic pathology...)

• Subjects with eating disorders (anorexia, bulimia...)

• Subjects currently receiving, or that received in the last 7 days, any antibiotics, antiseptics, antifungals, corticosteroids, vaccines, anti histamines, non steroid anti-inflammatory drugs

• Subjects that had a gastro-intestinal surgery in the last 3 months

• Subjects that had any surgery or intervention requiring general anaesthesia in the last month

• Subjects enrolled in another clinical study, currently or during the last 2 months (exclusion period from the former study)

• Subjects presenting congenital malformation

• Subjects with failure to thrive, growth retardation, or any developmental problem

• Subjects not attending day care centers or schools 5 days a week

• Subjects who cannot obtain both of their parents/legal guardians' signatures if they are separated/divorced and have joint custody of the child