N/A
N=125
Measuring the Influence of Kefir on Children's Stools on Antibiotics (MILK)
Respiratory Tract Infections
Bottom Line
View on ClinicalTrials.gov: NCT00481507 ↗Enrolled (actual)
125
Serious AEs
0.0%
Results posted
Mar 2012
Primary outcome: Primary: Incidence of Participants With Diarrhea by Parental Report — 18.0; 21.9 Percentage of participants — p=>.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Kefir (Other); Placebo (Other)
- Age
- Pediatric · 1+ yrs
- Sex
- All
- Sponsor
- Georgetown University
- Primary completion
- Apr 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Participants With Diarrhea by Parental Report |
18.0; 21.9 | >.05 |
| SECONDARY Incidence of Vomiting, Stomach Pain, Constipation, Runny Nose, Cough, Earaches, Fever, Irritability, Lethargy, and Loose Stools |
16.4; 10.9; 8.2; 14.1; 19.7; 17.2 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00481507). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.