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N/A Completed N=125 Randomized Quadruple-blind Prevention

Measuring the Influence of Kefir on Children's Stools on Antibiotics (MILK)

Source: ClinicalTrials.gov NCT00481507 ↗
Enrolled (actual)
125
Serious AEs
0.0%
Results posted
Mar 2012
Primary outcomePrimary: Incidence of Participants With Diarrhea by Parental Report — 18.0; 21.9 Percentage of participants — p=>.05

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.

Outcome Measures

OutcomeResultp-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

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
View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.

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