None listed
Conditions
Interventions
Group 1 Type of group
1 month
Placebo of the SMECTA will be presented in envelopes and will be administered orally for 14 days
Sponsors
UNIVERSIDAD PERUANA CAYETANO HEREDIA,
Eligibility
Inclusion criteria
Inclusion criteria: • The authorization statement, before completing any procedure related to the study, must be dated and signed by the accompanying adult and a witness (who could be a member of the medical team). • Male • Age between 1 and 36 months (inclusive). • Acute watery diarrhea defined by a minimum of 3 watery intestinal activities per day for less than 72 hours. • Need for oral rehydration, according to WHO criteria
Exclusion criteria
Exclusion criteria: • Current episode of diarrhea previously treated with any antidiarrheal medication. • Diarrhea caused by medications (eg antibiotic therapy administered the week before entry into the study). • History of a recent episode (2 weeks) of diarrhea. • History of persistent diarrhea (> 4 loose stools per day for> 14 days). • Dense blood in the stools. • Disease of poor assimilation diagnosed previously. • Severe dehydration requiring IV therapy, according to WHO criteria. • Child fed exclusively by breastfeeding. • Inability to drink. • Fever> 39 ° C, • History of illness that requires concomitant treatment. • Clinical evidence of another disease that requires antibiotic therapy. • You are currently receiving antibiotic therapy and / or an antidiarrheal agent. • Weight - height ratio <80%, (average value). • Child who has been previously included in this study or any other clinical trial completed less than one month ago.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Cumulative weight of stools during the first 48 hours expressed in g / kg of the current body weight. Measure:Issuance of depositions Timepoints:48 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:A medical visit will be made before the inclusion and at least every 6 hours until the H48 (or until the discharge) and once on the 7th and 14th, Measure:Body height (cm), body temperature (° C), abdominal circumference (cm), lower skin and examination of possible irritations Timepoints:every 6 hours until the H48 (or until the discharge) and once on the 7th and 14th ; Outcome name:A medical visit will be made before the inclusion and at least every 6 hours until the H48 (or until the discharge) and once on the 7th and 14th Measure:Number of stools during the reference period, Number of watery stools during the reference period, Number of soft stools during the reference period, Number of solid stools during the reference period, Stool emission (g / kg of current body weight ) until discharge. Timepoints:every 6 hours until the H48 (or until the discharge) and once on the 7th and 14th ; Outcome name:A medical visit will be made before the inclusion and at least every 6 hours until the H48 (or until the discharge) and once on the 7th and 14th Measure:Stool emission (g / kg of the current body weight) until discharge, Dense blood in the stools (classify as yes or no), Total number and duration of oral rehydration solution intakes, Number of episodes of vomiting during the reference period, Volume vomited during the reference period (until discharge). Timepoints:every 6 hours until the H48 (or until the discharge) and once on the 7th and 14th ; Outcome name:A medical visit will be made before the inclusion and at least every 6 hours until the H48 (or until the discharge) and once on the 7th and 14th Measure:Appetite, thirst, Search for signs of severe dehydration Timepoints:every 6 hours until the H48 (or until the discharge) and once on the 7th and 14th | — |
Countries
Peru
Outcome results
None listed