Measuring the Influence of Kefir on Children's Stools on Antibiotics (MILK) (MILK)
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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District of Columbia
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Washington, District of Columbia, United States, 20007
- Georgetown University Deptartment of Family Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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PLACEBO_COMPARATOR: Placebo
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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.
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EXPERIMENTAL: Kefir
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Incidence of Participants With Diarrhea by Parental Report
Time Frame: 14 days
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The primary outcome was the incidence of participants receiving antibiotics with diarrhea during the 14-day follow-up period, as determined by parental report.
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14 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of Vomiting, Stomach Pain, Constipation, Runny Nose, Cough, Earaches, Fever, Irritability, Lethargy, and Loose Stools
Time Frame: 14 days
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Incidence of Vomiting, Stomach Pain, Constipation, Runny Nose, Cough, Earaches, Fever, Irritability, Lethargy, and Loose Stools.
Outcomes assessed by parental report via daily diary and phone follow-ups with study research assistants on days 0, 5, 10, and 15.
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14 days
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2007-146
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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