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

St Marina University Hospital, Varna, Bulgaria

Status and phase

Completed

Phase 3

Conditions

Gastroenteritis

Clostridium Difficile Infection

Antibiotic Associated Diarrhea

Treatments

Dietary Supplement: L reuteri in children on antibiotics

Study type

Interventional

Funder types

Other

Identifiers

NCT01295918

128/13.01.2011

Details and patient eligibility

About

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.

Full description

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

Enrollment

100 patients

Sex

All

Ages

3 to 18 years old

Volunteers

No Healthy Volunteers

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