Acute diarrhea Digestive System
Conditions
Interventions
The investigators will enroll in this study 120 subjects accordingly to the inclusion and exclusion criteria. The patient will be assigned to the experimental group(A) or control group(B) by using a c
Sponsors
NOVENTURE S.L.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Acute gastroenteritis defined as a change in stool consistency according to the Bristol Stool Form (BSF) scale and/or an increase in the frequency of evacuations (typically =3 in 24 h) lasting more than 1 day and no longer than 3 days 2. Age group of children between = 3 months and = 14 years 3. A caregiver must provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Use of antibiotics, gelatine tannate, diosmectite, other probiotics, racecadotril, or zinc (including zinc containing ORS) within a week prior to enrolment 2. Exclusive breast feeding 3. Chronic diarrheal gastrointestinal disease (eg. inflammatory bowel diseases, cystic fibrosis, coeliac disease, food allergy) 4. Immunodeficiencies 5. Malnutrition (weight/height/length under 3rd percentile) (WHO Child Growth Standards will be used) 6. If needed, discontinuation or modification of the treatment may be considered at the discretion of the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of diarrhea, defined as the time until the normalization of stool consistency according to the Bristol stool form(BSF) scale (in BSF scale, numbers 2, 3, 4 and 5) or the time until the normalization of the number of stools (compared with the period before the onset of diarrhea) and the presence of normal stools for 48 h. Stool number and type evaluation will be done in each of the 5 days using the BSF scale. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Symptoms evaluation: vomiting, no. of stools, type of stools, flatulence, presence of blood in stool, apathy) and monitoring of adverse events and concomitant medication measured by the experimenter on each of the 5 days and at day 7 2. Morphological parameters (height, weight, abdominal girth) and Hemodynamic parameters (blood pressure [SBP, DBP]; pulse, temperature; respiration) measured at day 1, 5 and 7 3. Laboratory Investigations (urine summary, CBC, C-reactive protein, transaminases, glucose, coprocitogram) measured at day 1 and 5 | — |
Countries
Romania
Outcome results
None listed