Probiotic Lactobacillus Reuteri to Prevent Antibiotic-associated Diarrhea and Clostridium Difficile-related Infections in Hospitalized Children
Probiotic Lactobacillus Reuteri to Prevent Antibiotic-associated Diarrhea and Clostridium Difficile-related Infections in Hospitalized Children
The purpose of this study is to determine if the daily intake of the probiotic Lactobacillus
 reuteri prevents antibiotic-associated diarrhoea and related Clostridium difficile infections
 in children and adolescents.
Antibiotic-associated diarrhoea (AAD) occurs in up to 25% of all individuals receiving
 antibiotics (Bartlett, 2002). In hospitalized patients, AAD is related to significant
 increases in mortality, length of stay, and cost of medical care (McFarland, 2006).
 Twenty-nine percent of hospitalized patients may develop diarrhoea after antibiotic use;
 therefore, identifying strategies to minimize antibiotic-associated diarrhoea could be of
 significant medical and economic advantage (McFarland, 1998). A promising tool in this area
 is the probiotic Lactobacillus reuteri
Inclusion Criteria:

 -  3 - 18 years of age

 -  Receiving antibiotics for not more than 48 hours prior to enrolment and free from
 diarrhoea

 -  The signed informed consent by one/both parents / legal guardian and by the subject if
 she/he is 12 years or older

 -  Available throughout the study period

 -  No use of any other probiotic products during the study period (Bulgarian yoghurt
 without added probiotics can be used)

 -  Subject or parents/guardian should have the mental ability to understand and
 willingness to fulfil all the details of the protocol

 Exclusion Criteria:

 -  Three or more soft and unformed or watery stools per day at admission

 -  Receiving chemotherapy or radiation therapy

 -  Diagnosis of inflammatory bowel disease

 -  Enteral or parenteral nutrition only

 -  Requiring care in an intensive care unit

 -  Status post-bowel resection during hospitalization

 -  Receiving antibiotics four weeks prior to hospitalization

 -  Patient with severe life threatening illness or immunocompromised (HIV/AIDS, cancer,
 genetic disorders including cystic fibrosis, children with opportunistic infections,
 metabolic diseases)

 -  Pregnancy

 -  Lack of possibility to store the study product in a temperature below 25°C during the
 hot season of the year