Clinical trial NCT01295918: Probiotic Lactobacillus Reuteri to Prevent Antibiotic-associated Diarrhea and Clostridium Difficile-related Infections in Hospitalized Children
Official title: Efficacy of the Probiotic Lactobacillus Reuteri in Prevention of Antibiotic-associated Diarrhea and Clostridium Difficile-related Infections in Hospitalized Children and Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Antibiotic Associated Diarrhea
Clostridium Difficile Infection
Gastroenteritis
Keywords: probiotic
AAD
Lactobacillus reuteri
diarrhea
Lead sponsor: St Marina University Hospital, Varna, Bulgaria
Sponsor class: OTHER
First posted: 2011-02-15
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: To assess if the probiotic L. reuteri is effective in preventing AAD in children
timeFrame: 2 years
Secondary outcomes:
measure: Incidence of mild diarrhea and severity if diarrhea in children with probiotic treatment
timeFrame: 2 years
measure: Severity of diarrhoea in patients ingesting L. reuteri versus placebo
timeFrame: 2 years
measure: Frequency of stool samples positive for C. difficile toxin A and B
timeFrame: 2 years
measure: Frequencies of other gastrointestinal symptoms
timeFrame: 2 years
Other outcomes:
Locations:
city: Varna
country: Bulgaria
facility: St Marina University Hospital
city: Varna
country: Bulgaria
facility: Department of Pediatrics at St Marina University Hospital, Varna
Study officials:
affiliation: Pediatric gastroenterology ward
name: Miglena I Georgieva, PhD
role: PRINCIPAL_INVESTIGATOR
References: