Acute gastroenteritis (AGE) with evidence of dehydration Digestive System Acute gastroenteritis (AGE) with evidence of dehydration
Conditions
Interventions
Participants are randomised to one of two study arms in a 1:1 ratio using envelope randomisation.
Treatment arm: Participants receive Bio-Kult Infantis (an advanced probiotic multi-strain formula for
Sponsors
Probiotics International Ltd. (Protexin)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient Informed Consent (PIC) form signed by parent or legal guardian 2. Aged between 6 months and 6 years (up to the age of 5 years and 11 months) at the time of the signature of PIC 3. Confirmed acute diarrhoea according to WHO (at least 3 loose or watery stools within last 24h), which lasted less than 2 days (< 48 h) prior to signature of PIC 4. Diagnosed with acute gastroenteritis with evidence of dehydration (evaluated according to CDS) and in need of rehydration therapy (oral or IV) 5. Only patient treated in an out-patient setting (i.e. managed in an A+E department without subsequent hospitalization) is eligible; if it is decided that the patient needs to be hospitalized, he or she should not be included in the study ;Inclusion criteria: 1. Patient Informed Consent (PIC) form signed by parent or legal guardian 2. Aged between 6 months and 6 years (up to the age of 5 years and 11 months) at the time of the signature of PIC 3. Confirmed acute diarrhoea according to WHO (at least 3 loose or watery stools within last 24h), which lasted less than 2 days (< 48 h) prior to signature of PIC 4. Diagnosed with acute gastroenteritis with evidence of dehydration (evaluated according to CDS) and in need of rehydration therapy (oral or IV) 5. Only patient treated in an out-patient setting (i.e. managed in an A+E department without subsequent hospitalization) is eligible; if it is decided that the patient needs to be hospitalized, he or she should not be included in the study
Exclusion criteria
Exclusion criteria: 1. Patient diagnosed with gastroenteritis, but it is determined that they don’t need rehydration treatment (Score 0 according to CDS) 2. Patient who received antibiotic treatment within the last two months prior to onset of gastroenteritis 3. Patient who was taking probiotic supplements, dairy product with high bacterial count, such as Actimel or Yakult, or milk formula with probiotics, in the last month prior to onset of gastroenteritis (consumption of normal yoghurts is acceptable) 4. Patient who has to be hospitalized 5. Patient who is exclusively breastfed 6. Patient with diabetes 7. Immuno-compromised patient or patient with other severe chronic disorders that might influence the outcome of study therapy (as evaluated by Investigator) 8. Patient with oedema 9. Malnutrition (< 3% EBW; under the 3rd percentile of expected body weight) 10. Known lactose or gluten intolerance 11. Known allergy to cow’s milk proteins, fish, or any of the substances of the probiotic product or placebo 12. Patient who already participated and completed this study, and has repeated gastroenteritis while the enrolment into the study is still open 13. Patient participating in any other interventional clinical study 14. Patient with confirmed bacterial AGE and/or patient who need antibiotic treatment, will be excluded from the study;Exclusion criteria: 1. Patient diagnosed with gastroenteritis, but it is determined that they don’t need rehydration treatment (Score 0 according to CDS) 2. Patient who received antibiotic treatment within the last two months prior to onset of gastroenteritis 3. Patient who was taking probiotic supplements, dairy product with high bacterial count, such as Actimel or Yakult, or milk formula with probiotics, in the last month prior to onset of gastroenteritis (consumption of normal yoghurts is acceptable) 4. Patient who has to be hospitalized 5. Patient who is exclusively breastfed 6. Patient with diabetes 7. Immuno-compromised patient or patient with other severe chronic disorders that might influence the outcome of study therapy (as evaluated by Investigator) 8. Patient with oedema 9. Malnutrition (< 3% EBW; under the 3rd percentile of expected body weight) 10. Known lactose or gluten intolerance 11. Known allergy to cow’s milk proteins, fish, or any of the substances of the probiotic product or placebo 12. Patient who already participated and completed this study, and has repeated gastroenteritis while the enrolment into the study is still open 13. Patient participating in any other interventional clinical study 14. Patient with confirmed bacterial AGE and/or patient who need antibiotic treatment, will be excluded from the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of diarrhoea – “time to last diarrheal stool” is measured as the time in hours since the first time the Study Product is given until the last liquid/loose stool in the last 24 hours with at least three liquid/loose defecations.;Duration of diarrhoea – “time to last diarrheal stool” is measured as the time in hours since the first time the Study Product is given until the last liquid/loose stool in the last 24 hours with at least three liquid/loose defecations. | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of diarrheal episodes per day (frequency of defecation) is measured from patient diaries completed daily by the patient's caregiver throughout the study period.;Number of diarrheal episodes per day (frequency of defecation) is measured from patient diaries completed daily by the patient's caregiver throughout the study period. | — |
Countries
Croatia, Slovenia
Contacts
Public Contact; ;
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Outcome results
None listed