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Acute gastroenteritis (AGE) is one of the most common diseases among children. Oral rehydration therapy is the key treatment. According to the 2014 guidelines developed by the ESPGHAN probiotics may be considered in the management of children with AGE in addition to rehydration therapy. Considering that evidence on L reuteri remains limited, the investigators aim to assess the efficacy of L reuteri DSM 17938 for the treatment of AGE in children. Children vaccinated and not vaccinated against rotavirus will be evaluated separately.
Two independent reports (rotavirus-vaccinated and non-vaccinated children) are planned.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lactobacillus reuteri DSM 17938 | Active Comparator | 2 x 10(8) CFU. Both L reuteri DSM 17938 and placebo will be taken orally, twice daily 5 drops, for consecutive 5 days. |
|
| Placebo | Placebo Comparator | Placebo consists of an identical formulation, except active substance. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus reuteri DSM 17938 | Dietary Supplement | Lactobacillus reuteri DSM 17938 vs Placebo |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of diarrhea | (measured in hours) - time until the normalisation of stool consistency according to the Bristol Stool Form Scale(BSF) or Amsterdam Infant Stool Scale (ASF) - (in BSF scale, numbers 1, 2, 3, 4 and 5; in ASF scale, letters B or C), or the time until the normalisation of the number of stools (compared with the period before the onset of diarrhoea).and the presence of normal stools for 48 h. | 8 days |
| Measure | Description | Time Frame |
|---|---|---|
| Need for intravenous rehydration | Number of patients in each group requiring intravenous rehydration | 8 days |
| Duration of intravenous rehydration | 8 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Henryk Szymański, MD PhD | Szpital im.Świętej Jadwigi Śląskiej, Trzebnica, Poland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Szpiatal im.Świętej Jadwigi Śląskiej | Trzebnica | 55-100 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28835355 | Derived | Szymanski H, Szajewska H. Efficacy of Lactobacillus Reuteri DSM 17938 for the Treatment of Acute Gastroenteritis in Children: Protocol of a Randomized Controlled Trial. JMIR Res Protoc. 2017 Aug 23;6(8):e164. doi: 10.2196/resprot.7924. |
| Label | URL |
|---|---|
| published protocol | View source |
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| Placebo | Dietary Supplement | Lactobacillus reuteri DSM 17938 vs Placebo |
|
| Need for hospitalisation of outpatients | Number of patients enrolled as outpatient requiring hospitalisation - based on medical assesment | 8 days |
| Number of watery stools per day | 8 days |
| Vomiting | Number of participants with vomits and number of vomits per day | 8 days |
| Recurrence of diarrhoea (in 48 hours after intervention) | Number of patients in which diarrhoea recur after initial recovery in 48 hours | 48 hours |
| Severity of diarrhoea according to Vesikari scale | 8 days |
| Use of concomitant medications | 8 days |
| Adverse events | 8 days |