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EFFICACY AND SAFETY OF LACTEOL ON THE TREATMENT OF ACUTE DIARRHEA.

EFFICACY AND SAFETY OF LACTEOL ON THE TREATMENT OF ACUTE DIARRHEA.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-053-04
Enrollment
80
Registered
2004-08-11
Start date
Unknown
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

Lacteol® Type of group
2 sachets of Lacteol® are administered in the first dose and then 1 in each 12 hours for a maximum of 4.5 days. Group name:placebo Type of group
2 envelopes of placebo are administered in the first shot and then, 1 in every 12 innocents for a maximum of 4.5 days

Sponsors

AXCAN PHARMA INC. CANADA,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children with ages between 3 months and 4 years inclusive, who have diarrhea with mild or moderate dehydration.

Exclusion criteria

Exclusion criteria: Children with severe dehydration

Design outcomes

Primary

MeasureTime frame
Outcome name:Time of onset of the first of two consecutive normal stools or no stools for 12 hours. Measure:Time of onset of the first of two consecutive normal stools or no stools for 12 hours. Timepoints:12 hours—

Secondary

MeasureTime frame
Outcome name:Time of appearance of the last stools of diarrheal appearance. Measure:Time of appearance of the last stools of diarrheal appearance. Timepoints:12 hours—

Countries

Peru

Outcome results

None listed

Source: REPEC (via WHO ICTRP)