Decreasing Rates of Illness in Kids (DRINK)

May 12, 2008 updated by: Georgetown University

Decreasing Rates of Illnesses in Kids (DRINK)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 specifically for medicinal benefit. Such supplements used in children have shown some potential benefits in the treatment and prevention of various diseases, including diarrhea, asthma, necrotizing enterocolitis and allergies.

In the past few years, interest has increased in the health-enhancing role f specific foods, referred to as functional foods- foods providing health benefits beyond their nutritional value. Yogurt, a fermented milk product produced by the action of two bacteria, Lactobacillus (L.) bulgaricus and Streptococcus (S.) thermophilus, is a functional food. In fact, two-thirds of primary care physicians, who counsel patients about nutrition, recommend consuming yogurt containing live active cultures for their patients' health benefit. However, evidence for these health outcomes is not sufficiently strong.

Daycare and school centers are ideal places for the transmission of respiratory infections and childhood diarrhea, often resulting in many missed days of both daycare and parental work. Illnesses related to daycare centers have been estimated to cost $1.8 billion per year in the United States. One of the primary purposes of daycare is to allow parents to work while their child is taken care of, thus, absences due to illnesses have many direct and indirect associated costs. Unfortunately, children in daycare centers have been shown to have more outpatient doctor visits, emergency room visits, and increased usage of prescription medicines than children in daycare.

Our overall goal is to study a cultured dairy drik with an efficacious probiotic at doses that result in probiotic survival in the gastrointestinal tract and subsequently reduce illnesses in daycare/school children ages 3-6.

The rationale for focusing on a drink as a vehicle for transmission of probiotics, is that it has the potential for a much greater public health impact than using probiotics in a medicinal manner, such as pills or capsules. Yogurt and yogurt like probiotic drinks are well established and popular with children and parents, a product that traditionally provides live cultures to the diet, and can provide protein, vitamins and minerals that are nutritious for the child. Additionally, these drinks are relatively inexpensive, widely available, and easy to ingest even for individuals with lactose intolerance. These positive attributes make it an idea carrier to deliver the health benefits of probiotics.

Study Type

Interventional

Enrollment

638

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown University Department of Family Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Georgetown University

Collaborators

Dannon Company, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

July 24, 2006

First Submitted That Met QC Criteria

July 25, 2006

First Posted (Estimate)

July 26, 2006

Study Record Updates

Last Update Posted (Estimate)

May 14, 2008

Last Update Submitted That Met QC Criteria

May 12, 2008

Last Verified

April 1, 2007

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2006-291

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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