Efficacy of Lactobacillus Reuteri DSM 17938 for the Treatment of Acute Gastroenteritis in Children

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of Lactobacillus Reuteri DSM 17938 for the Treatment of Acute Gastroenteritis in Children: Randomised Controlled Trial

Conditions
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Acute Gastroenteritis

Intervention / Treatment
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* Dietary Supplement: Lactobacillus reuteri DSM 17938
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute gastroenteritis (AGE) defined as a change in stool consistency to loose or liquid form (according to the Bristol Stool Form (BSF) scale or in the case of infants, the Amsterdam Stool Form (ASF) scale) and/or an increase in the frequency of evacuations (typically ≥3 in 24 h), lasting for no longer than 5 days. Age: older than 1 month and younger than 60 months. A caregiver must provide written informed consent. Exclusion Criteria: Use of antibiotics within two weeks prior to enrolment. Use of gelatine tannate, diosmectite, probiotics, racecadotril, or zinc (including zinc containing ORS) within a week prior to enrolment (a single dose is allowed). Breast feeding (>50%) Chronic diarrhoeal gastrointestinal disease (e.g., inflammatory bowel disease, cystic fibrosis, coeliac disease, food allergy) Immunodeficiency Malnutrition (weight/height/length under 3rd percentile) (WHO Child Growth Standards will be used)

Ages Eligible for Study
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Minimum Age: 2 Months
Maximum Age: 60 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lactobacillus reuteri DSM 17938<br>2 x 10(8) CFU. Both L reuteri DSM 17938 and placebo will be taken orally, twice daily 5 drops, for consecutive 5 days. | Dietary Supplement: Lactobacillus reuteri DSM 17938<br>* Lactobacillus reuteri DSM 17938 vs Placebo<br>|
| Placebo Comparator: Placebo<br>Placebo consists of an identical formulation, except active substance. | Dietary Supplement: Placebo<br>* Lactobacillus reuteri DSM 17938 vs Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |