Effectiveness of Smecta in Combination With Oral Rehydration in the Treatment of Acute Watery Diarrhoea in Infants and Children

Ipsen302 enrolled

Overview

The purpose of this study is to evaluate the effectiveness of Smecta at decreasing stool weight, when compared to placebo, in the treatment of acute diarrhoea in children.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

302

Conditions

Diarrhoea

Interventions

Smecta (Diosmectite), duration of treatment - 7 daysDRUG

Eligibility

Sex: MALEMin age: 1 MonthMax age: 36 Months

Medical Language ↔ Plain English

Inclusion Criteria: * male * acute watery diarrhoea defined as at least 3 watery stools per 24 hours * duration of watery diarrhoea of less than 72 hours and with at least 1 watery stool for the last 12 hours * dehydration signs requiring oral rehydration according to current WHO guidelines Exclusion Criteria: * severe dehydration that needs IV therapy * presence of gross blood in stools * fever \>39 degrees Celsius

Locations (19)

Kluang Hospital

Kluang, Johor, Malaysia

Kajang Hospital

Jalan Semenyih, Kajang, Malaysia

Outcomes

Primary Outcomes

Cumulative faecal output (g/kg of body weight)

Time frame: 72 hours after first study drug intake

Secondary Outcomes

Cumulative faecal output (g)

Time frame: 72 hours after the first study drug intake

Faecal output (g/kg of body weight) per day

Time frame: 72 hours after the first study drug intake

Duration of watery diarrhoea (time of first study drug intake to watery diarrhoea disappearance)

Time frame: 7 days after the first study drug intake

Percentage of children withdrawn from the study due to IV rehydration (according to WHO guideline)

Time frame: 7 days after the first study drug intake

Percentage of body weight gain in comparison with body weight at inclusion

Time frame: Till 7 days after the first study drug intake

Percentage of children with at least one formed stool (H12, H24, H36, H48, H60, H72, then daily until Day 7)

Time frame: Till 7 days after first study drug intake

Daily until Day 7: stool frequency, watery stool number, formed stool number, soft stool number, percentage of patients with bottom skin irritation, percentage of patients with anal irritation, appetite on a 100mm visual analogue scale

Time frame: Till 7 days after first study drug intake

Tolerance of Smecta (assessed via adverse event reporting)

Time frame: Till 7 days after the last study drug intake

Data from ClinicalTrials.gov

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