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

This study has been completed.
Sponsor:
Collaborator:
Lifeway Foods, Inc.
Information provided by (Responsible Party):
Georgetown University
ClinicalTrials.gov Identifier:
NCT00481507
First received: May 30, 2007
Last updated: February 21, 2012
Last verified: February 2012
  Purpose

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 Intervention Phase
Respiratory Tract Infections
Drug: Kefir
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Measuring the Influence of Kefir on Children's Stools on Antibiotics (MILK)

Resource links provided by NLM:


Further study details as provided by Georgetown University:

Primary Outcome Measures:
  • Rate of Diarrhea by Parental Report [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    The primary outcome was the rate of diarrhea during the 14-day follow-up period in children receiving antibiotics.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 125
Study Start Date: July 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: 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 Drug: 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.

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 106-109 colony forming units of probiotics has been studied and recommended for health benefits.

  Eligibility

Ages Eligible for Study:   1 Year to 5 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
Responsible Party: Georgetown University
ClinicalTrials.gov Identifier: NCT00481507     History of Changes
Other Study ID Numbers: 2007-146
Study First Received: May 30, 2007
Results First Received: May 9, 2011
Last Updated: February 21, 2012
Health Authority: United States: Institutional Review Board

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
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on July 24, 2014