Status:
COMPLETED
Decreasing Rates of Illness in Kids (DRINK)
Lead Sponsor:
Georgetown University
Collaborating Sponsors:
Dannon Company, Inc.
Conditions:
Healthy
Eligibility:
All Genders
3-6 years
Phase:
PHASE3
Brief 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 age...
Detailed Description
Probiotics are live microorganisms, which when administered in sufficient amounts, may improve health. Often, probiotics are ingested as supplements in powder, pill, or liquid form, designed specifica...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
End Date :
June 1 2007
Estimated Enrollment :
638 Patients enrolled
Trial Details
Trial ID
NCT00356382
Start Date
September 1 2006
End Date
June 1 2007
Last Update
May 14 2008
Active Locations (1)
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1
Georgetown University Department of Family Medicine
Washington D.C., District of Columbia, United States, 20007