Acute Gastroenteritis
Conditions
Keywords
diarrhea, gelatin tannate, acute gastroenteritis
Brief summary
Gelatin tannate possesses astringent, antibacterial, and anti-inflammatory properties. It is increasingly being marketed as an antidiarrheal drug. A randomized, double blind, placebo-control trial was performed to assess the effectiveness of GT in management of children with acute gastroenteritis.
Interventions
DRUGGelatin Tannate
DRUGPlacebo
Placebo consists of an identical formulation, except active substance
Sponsors
Medical University of Warsaw
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 5 Years
Healthy volunteers
No
Inclusion criteria
* children \< 5 years old * diarrhea (defined as the passage of 3 or more loose or watery stools per day) for \> 1 day but \< 5 days * inform consent sign
Exclusion criteria
* regularly used antibiotics, probiotics, gelatin tannate, diosmectite, racecadotril within 7 days before admission * underlying gastrointestinal tract disorder presenting with diarrhea * breastfeeding \>50% * malnutrition (weight/high \<3pc)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of diarrhea | 7 days | time till the first normal stool from the onset of diarrhea or normalization number of stools and last those for 48hours |
Secondary
| Measure | Time frame |
|---|---|
| Need of hospitalization in outpatients | 7 days |
| Vomiting | How many times for 7days |
| Weight gain | 7 days |
| Need of intravenous rehydration due to diarrhea | 7 days |
| Frequency of watery stools | 7 days |
| Adverse effects | 7 days |
| Severity of diarrhea due to modified Vesikari score | 7 days |
| Diarrhea recurrence | 7 days |
Countries
Poland
Outcome results
None listed