Effectiveness of Smecta in the Treatment of Acute Diarrhoea in Children

EFFECTIVENESS OF SMECTA IN COMBINATION WITH ORAL REHYDRATION IN THE TREATMENT OF ACUTE ACUTE DIARRHEA IN CHILDREN

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

REPEC

Registry ID

PER-018-06

Enrollment

300

Registered

2006-05-29

Start date

2006-06-23

Completion date

Unknown

Last updated

2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

GROUP 1 Type of group

This group will be treated with standard therapy of Oral Rehydration Salts (SRO, composed of Sodium Chloride 2.6 g, Potassium Chloride 1.5 g, Glucose, Anhydrous 13.5 g, Sodium Citrate, Dihydrate 2.9 g) according to clinical criteria. In addition, SMECTA® will be administered. The dose will vary according to the age of the patient: 1) From 1 to 12 months of age: 1 envelope BID PO for 3 days and 1 envelope QD PO from the fourth day until the end of treatment. 2) From> 12 to 36 months of age: 2

This group will be treated with standard therapy of Oral Rehydration Salts (SRO, composed of Sodium Chloride 2.6 g, Potassium Chloride 1.5 g, Glucose, Anhydrous 13.5 g, Sodium Citrate, Dihydrate 2.9 g) according to clinical criteria. In addition, SMECTA Placebo will be administered. The dose will vary according to the age of the patient: 1) From 1 to 12 months of age: 1 envelope BID PO for 3 days and 1 envelope QD PO from the fourth day until the end of treatment. 2) From> 12 to 36 months of

Eligibility

Inclusion criteria

Inclusion criteria: 1. Informed written consent signed and signed before completing any procedure related to the study, granted by a parent or legal guardian accompanying the patient. 2. Male. 3. Age: from 1 month to 36 months. 4. Acute watery diarrhea. 5. Duration of acute watery diarrhea less than 72 hours, with at least 1 liquid deposition in the last 12 hours. 6. Signs of dehydration that require oral rehydration, according to current WHO guidelines. 7. Acceptance of hospitalization for 72 hours.

Exclusion criteria

Exclusion criteria: 1. Acute dehydration requiring IV treatment. 2. Evident presence of blood in the stool. 3. Fever> 39 ° C. 4. History of recent episodes (2 weeks) of diarrhea. 5. Previous history of episodes of persistent diarrhea. 6. Malabsorption syndrome previously diagnosed. 7. History of organic gastrointestinal disease. 8. Current treatment with antidiarrheal medication in therapeutic doses and for at least 48 hours. 9. Drug-induced diarrhea. 10. Clinical evidence of another disease that requires antibiotic treatment or any other treatment that could interfere with the evaluation of the study medication. 11. Children exclusively breastfed. 12. Inability to drink. 13. Weight / height ratio <80%. 14. Children previously included in this study.

Design outcomes

Primary

Measure	Time frame
Outcome name:Stool weighing in electronic scales. Measure:Cumulative fecal weight in g / kg of body weight, of the first 72 hours. Timepoints:The weight of the stool will be measured until 72 hours after the first dose of the medication, regardless of whether the diarrhea has already subsided before the 72nd hour.	—

Secondary

Measure	Time frame
Outcome name:Stool weighing in electronic scales. Clinical evaluation Measure:Cumulative result of stool weight in g, of the first 72 hours. Result of stool weight (g / kg of body weight) per day. Result of stool weight (g), per day of the first 72 hours. Duration of diarrhea. Percentage of children withdrawn from the study due to the need for IV rehydration. Percentage of body weight increase in H72 and Day 7. Percentage of children with at least one deposition formed. Timepoints:The weight of the stool will be measured until 72 hours after the first dose of the medication, regardless of whether the diarrhea has already subsided before the 72nd hour. Clinical evaluation: Days 1, 2 and 3 of the treatment and during the follow-up (until 7 days). ; Outcome name:Clinical evaluation with application of the Analog Visual Scale of 100 mm. Measure:Frequency of depositions. Number of liquid depositions. Number of soft stools. Number of formed depositions. Percentage of patients with irritation of the skin of the buttocks. Percentage of patients with anal irritation. Appetite. Timepoints:Days 1, 2 and 3 of the treatment and during the follow-up (until 7 days). ; Outcome name:Clinical evaluation of adverse events and classification according to the categorization of the Medical Dictionary of Regulatory Activities (MedDRA). Measure:Safety of the treatment. Timepoints:The evaluation of adverse events will be made at the time an event occurs.	—

Measure

Time frame

Outcome name:Stool weighing in electronic scales. Clinical evaluation Measure:Cumulative result of stool weight in g, of the first 72 hours. Result of stool weight (g / kg of body weight) per day. Result of stool weight (g), per day of the first 72 hours. Duration of diarrhea. Percentage of children withdrawn from the study due to the need for IV rehydration. Percentage of body weight increase in H72 and Day 7. Percentage of children with at least one deposition formed. Timepoints:The weight of the stool will be measured until 72 hours after the first dose of the medication, regardless of whether the diarrhea has already subsided before the 72nd hour. Clinical evaluation: Days 1, 2 and 3 of the treatment and during the follow-up (until 7 days). ; Outcome name:Clinical evaluation with application of the Analog Visual Scale of 100 mm. Measure:Frequency of depositions. Number of liquid depositions. Number of soft stools. Number of formed depositions. Percentage of patients with irritation of the skin of the buttocks. Percentage of patients with anal irritation. Appetite. Timepoints:Days 1, 2 and 3 of the treatment and during the follow-up (until 7 days). ; Outcome name:Clinical evaluation of adverse events and classification according to the categorization of the Medical Dictionary of Regulatory Activities (MedDRA). Measure:Safety of the treatment. Timepoints:The evaluation of adverse events will be made at the time an event occurs.

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Countries

Peru

Outcome results