None listed
Conditions
Interventions
GROUP 1 Type of group
This group will be treated with Dexecadotril, at a dose of 10 mg, PO, TID + Ondansetron Placebo, PO, TID. This scheme will be administered for a minimum of 48 hours until the recovery of diarrhea, up to a maximum of 5 days.
Group name:GROUP 4 Type of group
This group will be treated with Dexecadotril, at a dose of 10 mg, PO, TID + Ondansetron, at a dose of 1 mg, PO, TID. This scheme will be administered for a minimum of 48 hours until the recovery of diarrhea, up to a maximum of 5 days, up to a maximum of 5 days.
Sponsors
CONSULTORES ASOCIADOS PARA EL DESARROLLO DE LA SALUD. DS-CONSULT S.A.C.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male patients from 3 months of age to 36 months of age, suffering from acute diarrhea, of presumed infectious origin. 2. Written informed consent granted by the parent or legal guardian.
Exclusion criteria
Exclusion criteria: 1. Previous episode of diarrhea within the last 2 weeks. 2. Presence of blood in the stool. 3. Patients who have received treatment with antibiotics at a therapeutic dose for one day, within the previous 48 hours. Use of acetylsalicylic acid, antidiarrheal or antiemetic, at any dose in the last 12 hours. 4. Severe malnutrition. 5. Any other disease or condition that requires antibiotic therapy at the time of inclusion. 6. Severe dehydration requiring intravenous rehydration. 7. Known hypersensitivity to Racecadotril or Ondansetron. 8. Previous diagnosis of lactose intolerance. 9. Concomitant disease that could interact with the study. 10. Patients who participate in another study or who have participated in a study during the preceding month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Collection of watery stools and vomiting in pre-weighed diapers. Measure:Volume of stool and vomit in the first 48 hours. Timepoints:At 48 hours. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Criteria 1: Collection of watery stools and vomiting in previously weighed diapers. Criterion 2: Collection of stools and vomiting until recovery, defined as 12 hours without liquid stools or 2 consecutive stools. Or until the end of the treatment. Criterion 3: Period between the first intake of treatment and the cessation of diarrhea. Criterion 4: Period between the first intake of treatment and the cessation of vomiting. Criterion 5: Quantification of the total volume of oral rehydration solution administered. Criterion 6: Quantification of the total volume of intravenous rehydration solution administered. Criterion 7: Stool test for Rotavirus, in a subgroup of patients. Criterion 8: Clinical evaluation to determine if the recovery criteria are met: 12 hours without liquid stools or 2 consecutive formed stools. Criterion 9: Normal weight minus weight at the time of inclusion against weight in the final visit. Measure:1) Volume of deposition and vomiting of 24 hours. 2) Total volume of deposition and vomiting from the beginning of the study until the recovery or until the end of the treatment. 3) Duration of diarrhea. 4) Duration of episodes of vomiting. 5) Total intake of the oral rehydration solution. 6) Percentage of intravenous rehydration necessary. 7) Rotavirus status. 8) Recovery percentage at discharge. 9) Weight trend under treatment. Timepoints:Criterion 1: 24 hours Criteria 2, 3 and 4: When the event occurs. Criteria 5 and 6: Day 5 or at the end of treatment. Criteria 7, 8 and 9: Days 1, 2, 3, 4 and 5. ; Outcome name:Criterion 1: Clinical evaluation of any medical event, undesirable, in a patient to whom the study medication is administered. Criterion 2: Complete physical examination, which will emphasize the state of dehydration and nutrition, according to WHO criteria. Criterion 3: Counting of leukocytes, red blood cells and differential, platelets, total plasma proteins, s | — |
Outcome results
None listed