Probiotic Lactobacillus Reuteri to Prevent Antibiotic-associated Diarrhea and Clostridium Difficile-related Infections in Hospitalized Children (AADreuter)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01295918|
Recruitment Status : Completed
First Posted : February 15, 2011
Last Update Posted : September 10, 2013
|Condition or disease||Intervention/treatment||Phase|
|Antibiotic Associated Diarrhea Clostridium Difficile Infection Gastroenteritis||Dietary Supplement: L reuteri in children on antibiotics||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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 Start Date :||February 2011|
|Primary Completion Date :||June 2013|
|Study Completion Date :||September 2013|
|No Intervention: Placebo, antibiotic, diarrhea|
Placebo Comparator: L. reuteri, Antibiotic, diarrhoea
L. reuteri will be ingested by patients on antibiotic therapy, effect of probiotic on AAD will be assessed.
Dietary Supplement: L reuteri in children on antibiotics
Each patient will be assigned to receive either a probiotic supplement containing 1 x 10 8 CFU Lactobacillus reuteri DSM 17938 in the form of one chewable tablet once per day (BioGaia AB, Stockholm, Sweden) or placebo, identical in taste and appearance. The probiotic or placebo will be taken 2 hours after lunch each day, during the entire period of antibiotic treatment and for an additional 7 days.
- To assess if the probiotic L. reuteri is effective in preventing AAD in children [ Time Frame: 2 years ]Incidence of diarrhea during and after treatment with antibiotics in patients ingesting L. reuteri versus placebo during the study period, measured as mean number of episodes per patient. An episode of diarrhea is defined as three or more (≥ 3) soft and unformed or watery bowel movements per day for at least 48 hours.
- Incidence of mild diarrhea and severity if diarrhea in children with probiotic treatment [ Time Frame: 2 years ]Incidence of mild diarrhoea during and after treatment with antibiotics in patients ingesting L. reuteri versus placebo during the study period is measured as mean number of episodes per patient. An episode of mild diarrhoea is defined as any soft and unformed or watery bowel movements not fulfilling the definition of AAD.
- Severity of diarrhoea in patients ingesting L. reuteri versus placebo [ Time Frame: 2 years ]Severity of diarrhoea in patients ingesting L. reuteri versus placebo is measured as the total number of soft and unformed or watery bowel movements during an episode of diarrhoea and the presence of blood and mucus in faeces.
- Frequency of stool samples positive for C. difficile toxin A and B [ Time Frame: 2 years ]Frequency of stool samples positive for C. difficile toxin A and B at baseline, when presenting with diarrhoea during the study period, and at the follow-up 21 days post-antibiotic treatment is done to detect possible clearance of C. difficile, in patients ingesting L. reuteri versus placebo.
- Frequencies of other gastrointestinal symptoms [ Time Frame: 2 years ]Frequencies of other gastrointestinal symptoms during antibiotic use and 7 and 21 days after cessation of antibiotic use, in the L. reuteri group versus placebo is to be assessed by the validated GSRS score (Gastrointestinal Symptom Rating Score, Svedlund et al., 1988).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01295918
|St Marina University Hospital|
|Varna, Bulgaria, 9002|
|Department of Pediatrics at St Marina University Hospital, Varna|
|Varna, Bulgaria, 9010|
|Principal Investigator:||Miglena I Georgieva, PhD||Pediatric gastroenterology ward|