Acute gastroenteritis (acute infectious diarrhoea) Digestive System
Conditions
Interventions
The intervention used in the study were: Tasectan Plus - a Gelatine Xyloglucan CE mark Medical Device Plus ORS (Oral Rehidration Solution) versus ORS alone. Administration of the treatments was done
Sponsors
Novintethical Pharma SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Children aged 3 months to 12 years with diagnosis of acute gastroenteritis (acute infectious diarrhoea); acute diarrhoea is defined as ‘three or more liquid stools (rated 6 or 7 on Bristol Stool Scale) a day for less than 72 hours’ 2. Patient with absent or mild-moderate dehydration which can be addressed through oral rehydration therapy (ORS) 3. Patient for whom oral rehydration therapy (ORS) and diet is considered the appropriate treatment by the treating physician 4. Patients for whom hospitalisation is not needed and can be treated in an out-patient setting 5. Patients for whom antibiotic therapy is considered not necessary by the treating physician 6. Informed consent signed by the legal representative of the child to participate in the clinical trial
Exclusion criteria
Exclusion criteria: 1. Infantile colic 2. Diarrhoea consequently to milk/protein intolerance 3. Severe dehydration needing intravenous rehydration 4. Need for hospitalisation 5. Use of antibiotics before the screening visit or need of antibiotics based on the clinical judgement of treating physician 6. Use of antidiarrheal treatment (antimotility, antisecretory, or adsorbent agents) before the screening visit or need of antidiarrheal agents based on the clinical judgement of treating physician 7. Chronic or toxic diarrhoea 8. Impossibility to follow the patient for more than 12 hours
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurence of AE | — |
Secondary
| Measure | Time frame |
|---|---|
| Reduction of stools During the study we had 3 visits: Baseline visit, Visit 1 (2 days after baseline), Visit 2 (5 days after baseline). A telephone follow-up visit was performed at 10 days after Visit 2. The method used to measure the outcomes were by using a daily diary which has captured all the necessary information to measure the outcomes. | — |
Countries
Romania
Contacts
Public ContactManolache Mihai
Outcome results
None listed