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AIM: To determine the efficacy of Lactobacillus reuteri DSM 17938 at a dose of 10(9) CFU for the prevention of nosocomial diarrhea.
TRIAL DESIGN: Double-blind, placebo controlled RCT. INTERVENTION: L reuteri DSM 17938 in a daily dose of 10(9) CFU. PRIMARY OUTCOME: Nosocomial diarrhoea (3 or more loose or watery stools in a 24 h that will occur more than 72 h after admission).
Nosocomial diarrhea is a common problem in hospitalized children. Previously, it has been documented that the administration of L reuteri DSM 17938 at a dose of 10(8) colony forming units (CFU) compared with placebo had no effect on the overall incidence of nosocomial diarrhea (Wanke & Szajewska, J Pediatr 2012). Whether higher doses of L reuteri DSM 17938 have such effects needs to be substantiated in further randomized trials.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| L. reuteri DSM 17938 | Active Comparator | Lactobacillus reuteri DSM 17938,10(9)CFU/daily (for the duration of hospitalization) ARM I: Rotavirus vaccinated patients ARM II: Non-rotavirus vaccinated patients |
|
| Placebo | Placebo Comparator | Placebo consists of an identical formulation in all respects except that the live probiotic bacteria were excluded for the duration of hospitalization |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus reuteri DSM 17938 | Dietary Supplement | 10(9) CFU/daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of nosocomial diarrhea (defined as the passage of 3 or more loose or watery stools in a 24-hour period that will occur more than 72 hours after admission) | Any time starting 72 h after admission |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of diarrhea- passage of 3 or more loose or watery stools in a 24-h period | from the time of admission to the time of discharge of the hospital-expected average 3-5 days | |
| Duration of diarrhea (ie, time till the last loose or watery stool from the onset of diarrhea) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hanna Szajewska, MD, Profesor | Medical University of Warsaw | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Pediatrics, Medical University of Warsaw | Warsaw | 01-410 | Poland |
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| ID | Term |
|---|---|
| D003967 | Diarrhea |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Placebo |
| Dietary Supplement |
|
| during hospitalisation (expected average 3-5 days) and 72 h after discharge |
| Need and the length of intravenous rehydration due to diarrhea | During the hospitalization-expected average 3-5 days |
| Prolongation of the hospitalization due to nosocomial diarrhea | during the hospitalization-expected average 3-5 days |
| Incidence of rotavirus diarrhea (ie, detection of rotavirus or antigen in the stools) | Positive test for rotavirus or antigen in the stool sample | 72 hours after admission to the hospital to 72 hours after discharge |
| Incidence of chronic diarrhea- lasting more than 14 days | untill 14 days after onset of diarrhea |
| Length of hospital stay | During hospitalisation-expected average 3-5 days |
| Adverse effects | During hospitalisation (expected average 3-5 days) plus 72 h after discharge |