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EFFECTIVENESS OF A PROBIOTIC PREPARATION AND PREBIOTIC PREPARATION IN THE TREATMENT OF CHILDREN WITH ACUOUS ACUTE DIARRHEA

Not Applicable
Conditions
-K591 Functional diarrhoea
Functional diarrhoea
K591
Registration Number
PER-033-99
Lead Sponsor
CHILD HEALTH FOUNDATION,
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

• Age: 6 to 24 months (± 15 days with respect to the exact date of birth)
• Diarrhea: 3 or more liquid stools during the last 24 hours and at least 1 during the initial period of rehydration
• Dehydration: mild or moderate, to be corrected during the initial 4-6 hours.

Exclusion Criteria

• Diarrhea for more than 5 days
• Blood in the stool seen by the mother (or whoever primarily cares for the patient) or by the examiner
• Exclusive breastfeeding
• Severe dehydration (that is, intravenous treatment at admission is required)
• Obvious systemic disease (eg, high fever, meningitis, sepsis, pneumonia, rashes, generalized pyodermatitis)
• Recent episode of diarrhea (that is, within 7 days before the start of the current episode)
• Recent use of oral antibiotics at therapeutic doses (that is, within 72 hours prior to admission)
• There is no clinical improvement after the initial period of 4-6 hours of rehydration
• Severe protein-calorie malnutrition (ie, weight for height at or below 70% of the NCHS median)
• Permanent residence of the family is outside the city of Lima or the family has plans to move from Lima within the next 6 months.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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