Decreasing Rates of Illness in Kids (DRINK)

NCT00356382 | Completed Phase 3 DMC

• 1 other identifier: 2006-291
• Study Type: interventional
• Target: 638
• Locations: 1 country
• Sites: 1

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 ages 3 to 6.

Conditions

Healthy

Keywords

probiotic; Lactobacillus (L.) casei; cultured dairy drink; Health

Outcome Measures

Primary Outcomes (1)

• Mean of sick days due to upper-respiratory and gastro-intestinal infections and diarrhea.

Interventions

Lactobacillus (L.) casei DRUG

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• Georgetown University: lead
• Dannon Company, Inc.: collaborator

Study Sites (1)

Georgetown University Department of Family Medicine

Washington D.C., District of Columbia, 20007, United States

Location

MeSH Terms

Interventions

Lacteol

Study Officials

• Daniel Merenstein, MD

  Georgetown University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 24, 2006
• First Posted: July 26, 2006
• Study Start: September 1, 2006
• Primary Completion: June 1, 2007
• Study Completion: June 1, 2007
• Last Updated: May 14, 2008

Record last verified: 2007-04

Locations

US (1)