A Phase 3 interventional study of L reuteri in children on antibiotics in Antibiotic Associated Diarrhea, Clostridium Difficile Infection and Gastroenteritis, sponsored by St Marina University Hospital, Varna, Bulgaria. Completed at 2 sites in Bulgaria. Open to participants aged 3 Years to 18 Years. Per ClinicalTrials.gov, last updated 2013-09-10.
Sponsored by St Marina University Hospital, Varna, Bulgaria · Phase 3, Interventional, and Prevention
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
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 100 is below the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →St Marina University Hospital, Varna, Bulgaria is the lead sponsor of 2 studies on the registry; none are open to participants now.
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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
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.
Time frame: 2 years
Incidence of mild diarrhea and severity if diarrhea in children with probiotic treatment
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.
Time frame: 2 years
Severity of diarrhoea in patients ingesting L. reuteri versus placebo
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.
Time frame: 2 years
Frequency of stool samples positive for C. difficile toxin A and B
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.
Time frame: 2 years
Frequencies of other gastrointestinal symptoms
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).
Time frame: 2 years
This study is completed, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.
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St Marina University Hospital, Varna, Bulgaria