Measuring the Influence of Kefir on Children's Stools on Antibiotics (MILK)
Condition: Respiratory Tract Infections
MeSH terms: Respiratory Tract Infections
Study type: Interventional

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
      2-3.5 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.
    

Intervention name(s): Kefir; Placebo
Intervention type(s): Other; Other
Intervention description(s): The intervention was Kefir,a drink that is commercially available in the United States. The following probiotics are present in the Kefir: Lactococcus lactis, Lactococcus plantarum, Lactococcus rhamnosus, Lactococcus casei, Lactococcus lactis subspecies diacetylactis, Leuconostoc cremoris, Bifidobacterium longum, Bifidobacterium breve, Lactobacillus acidophilus, and 1 yeast, Saccharomyces florentinus. Parents were asked to ensure that their enrolled child consumed at least half of the bottle (150mL) everyday.; The intervention was Kefir, a drink that is commercially available in the United States. The following probiotics are present in active Kefir: Lactococcus lactis, Lactococcus plantarum, Lactococcus rhamnosus, Lactococcus casei, Lactococcus lactis subspecies diacetylactis, Leuconostoc cremoris, Bifidobacterium longum, Bifidobacterium breve, Lactobacillus acidophilus, and 1 yeast, Saccharomyces florentinus. The placebo group was heat-treated to kill all cultures. Parents were asked to ensure that their enrolled child consumed at least half of the bottle (150 mL)everyday.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Probiotic; Cultured dairy drink; Health; 10 day antibiotic; Otherwise healthy