|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Georgetown University |
|---|---|
| Collaborator: |
Lifeway Foods, Inc. |
| Information provided by: | Georgetown University |
| ClinicalTrials.gov Identifier: | NCT00481507 |
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 |
Phase III |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study |
| Official Title: | Measuring the Influence of Kefir on Children's Stools on Antibiotics (MILK) |
| 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) |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, District of Columbia | |
| Georgetown University Deptartment of Family Medicine | |
| Washington, District of Columbia, United States, 20007 | |
| Principal Investigator: | Daniel Merenstein, MD | Georgetown University |
More Information
| Responsible Party: | Lifeway Foods, Inc. ( Julie Smolyansky ) |
| Study ID Numbers: | 2007-146 |
| Study First Received: | May 30, 2007 |
| Last Updated: | May 12, 2008 |
| ClinicalTrials.gov Identifier: | NCT00481507 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Probiotic Cultured dairy drink Health 10 day antibiotic Otherwise healthy |
|
Anti-Infective Agents Anti-Bacterial Agents Respiratory Tract Diseases Respiratory Tract Infections |
Therapeutic Uses Infection Pharmacologic Actions |