Measuring the Influence of Kefir on Children's Stools on Antibiotics (MILK)
| Status: | Completed |
|---|---|
| Conditions: | Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 1 - 5 |
| Updated: | 1/17/2018 |
| Start Date: | July 2007 |
| End Date: | April 2008 |
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.
on preventing antibiotic-associated diarrhea compared to placebo in children ages 1-5.
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.
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.
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
We found this trial at
1
site
3900 Reservoir Road Northwest
Washington, District of Columbia 20007
Washington, District of Columbia 20007
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