Decreasing Rates of Illness in Kids (DRINK)

Completed · Phase 3

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT00356382

Run by

Georgetown University

People needed

638

Starts

2006-09-01

Expected to finish

2007-06-01

Last updated by the study team

2008-05-14

Who can join

Age: 3 and older, up to 6. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Georgetown University Department of Family Medicine — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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