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Measuring the Influence of Kefir on Children's Stools on Antibiotics (MILK) (MILK)

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ClinicalTrials.gov Identifier: NCT00481507
Recruitment Status : Completed
First Posted : June 1, 2007
Results First Posted : March 26, 2012
Last Update Posted : January 16, 2018
Sponsor:
Collaborator:
Lifeway Foods, Inc.
Information provided by (Responsible Party):
Georgetown University

Brief Summary:
The purpose of this study is to determine the effectiveness of commercially available kefir on preventing antibiotic-associated diarrhea compared to placebo in children ages 1-5.

Condition or disease Intervention/treatment Phase
Respiratory Tract Infections Other: Kefir Other: Placebo Not Applicable

Detailed Description:

Diarrhea is a common and costly disease of children in the United States. Children less than 5 years of age experience 20-35 million episodes of diarrhea per year. These episodes lead to 2-3.5 million physician visits (which account for 10% of all visits), more than 200,000 hospitalizations (13% of hospital admissions in children less than 5 years), and 325-425 deaths annually. In 1991, the outpatient costs of treating diarrhea for children under age 3 were calculated at 0.6-1 billion dollars per year.

Acute diarrhea in young children is almost always caused by infections or antibiotics. The rate of diarrhea associated with antibiotic usage is 20-35%, with children 3-36 months receiving on average 2-3 antibiotic prescriptions per year. Studies have shown that diarrhea due to either antibiotics or infections is caused by disturbances of the microflora of the gastrointestinal tract.

The current treatment for diarrhea in young children is oral rehydration, which is used to treat dehydration but plays no role in prevention. Probiotics are live microorganisms which, when administered in sufficient amounts, may improve health. Probiotics have the potential to treat and prevent diarrhea by improving the intestinal flora when disturbed by events such as antibiotics. Important to their use is that they are of human origin, survive passage through the gut, and are safe in very large dosages.

Studies have examined the potential health benefits of probiotics in the prevention and treatment of both antibiotic and infectious diarrhea. The probiotics have generally been given as supplements or pills. In placebo controlled randomized studies using these techniques, probiotics have generally been shown to decrease antibiotic associated diarrhea by 15-25% over placebo. Other studies have enrolled children with acute diarrhea, generally from rotavirus, and found a 30-50% cure rate in the probiotic group over placebo.

Kefir, available in the United States, is a milk product derived by the action of ten probiotics. A daily dose of 10^6-10^9 colony forming units of probiotics has been studied and recommended for health benefits.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Measuring the Influence of Kefir on Children's Stools on Antibiotics (MILK)
Study Start Date : July 2007
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Placebo Other: Placebo
The intervention was Kefir, a drink that is commercially available in the United States. The following probiotics are present in active Kefir: Lactococcus lactis, Lactococcus plantarum, Lactococcus rhamnosus, Lactococcus casei, Lactococcus lactis subspecies diacetylactis, Leuconostoc cremoris, Bifidobacterium longum, Bifidobacterium breve, Lactobacillus acidophilus, and 1 yeast, Saccharomyces florentinus. The placebo group was heat-treated to kill all cultures. Parents were asked to ensure that their enrolled child consumed at least half of the bottle (150 mL)everyday.
Experimental: Kefir Other: Kefir
The intervention was Kefir,a drink that is commercially available in the United States. The following probiotics are present in the Kefir: Lactococcus lactis, Lactococcus plantarum, Lactococcus rhamnosus, Lactococcus casei, Lactococcus lactis subspecies diacetylactis, Leuconostoc cremoris, Bifidobacterium longum, Bifidobacterium breve, Lactobacillus acidophilus, and 1 yeast, Saccharomyces florentinus. Parents were asked to ensure that their enrolled child consumed at least half of the bottle (150mL) everyday.



Primary Outcome Measures :
  1. Percentage of Participants With Diarrhea by Parental Report [ Time Frame: 14 days ]
    The primary outcome was the percentage of participants receiving antibiotics with diarrhea during the 14-day follow-up period, as determined by parental report.


Secondary Outcome Measures :
  1. Absences From Daycare or School Owing to Illness, Missed Parental Work Owing to the Child Being Ill, Vomiting, Stomach Pain, Constipation, Runny Nose, Cough, Earaches, Fever, Irritability, Lethargy, and Loose Stools. [ Time Frame: 14 days ]


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Ages Eligible for Study:   1 Year to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Ability to speak and write English
  • Aged 1-5 years
  • Male or female
  • Diagnosed with an upper respiratory infection and placed on a penicillin class antibiotic regimen for 10 days

Exclusion Criteria:

  • Developmental delays
  • Chronic conditions, such as diabetes or asthma, that require medication
  • Prematurity, birth weight <2500 grams
  • Allergy to kefir and/or milk
  • Active diarrhea
  • Congenital anomalies
  • Failure to thrive
  • Parental belief of lactose intolerance

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00481507


Locations
United States, District of Columbia
Georgetown University Deptartment of Family Medicine
Washington, District of Columbia, United States, 20007
Sponsors and Collaborators
Georgetown University
Lifeway Foods, Inc.
Investigators
Principal Investigator: Daniel Merenstein, MD Georgetown University

Publications of Results:
Responsible Party: Georgetown University
ClinicalTrials.gov Identifier: NCT00481507     History of Changes
Other Study ID Numbers: 2007-146
First Posted: June 1, 2007    Key Record Dates
Results First Posted: March 26, 2012
Last Update Posted: January 16, 2018
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Georgetown University:
Probiotic
Cultured dairy drink
Health
10 day antibiotic
Otherwise healthy

Additional relevant MeSH terms:
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents