Probiotic Lactobacillus Reuteri to Prevent Antibiotic-associated Diarrhea and Clostridium Difficile-related Infections in Hospitalized Children

Efficacy of the Probiotic Lactobacillus Reuteri in Prevention of Antibiotic-associated Diarrhea and Clostridium Difficile-related Infections in Hospitalized Children and Adolescents

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