Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00481507
Status:
COMPLETED
Last Update Posted:
2019-07-10
First Post:
2007-05-30
Brief Title:
Measuring the Influence of Kefir on Childrens Stools on Antibiotics MILK
Sponsor:
Georgetown University
Organization:
Georgetown University
Study Overview
Official Title:
Measuring the Influence of Kefir on Childrens Stools on Antibiotics MILK
Status:
COMPLETED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MILK
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
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 2-35 million physician visits which account for 10 of all visits more than 200000 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 06-1 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None