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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-033-99
Enrollment
225
Registered
1999-01-01
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

Placebo- Placebo Type of group
Treatment, Days 1-5: SRO + Placebo + Regular feeding Treatment, Days 6-19: Rice cereal + Placebo + Regular feeding Group name:Probiotic- Prebiotic Type of group
Treatment, Days 1-5: SRO + Prebiotic + Regular feeding Treatment, Days 6-19: Rice cereal + Prebiotic + Regular feeding

Sponsors

CHILD HEALTH FOUNDATION,
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Outcome name:Patients will be discharged from the hospital 24 hours after cessation of diarrhea. Cessation of diarrhea is considered as 12 hours without stools or the appearance of a deposition formed. Measure:Cessation of diarrhea Timepoints:19 days

Countries

Peru

Outcome results

None listed

Source: REPEC (via WHO ICTRP)