MedPath

Survey in efficacy of probiotics in infantile colic

Phase 2
Conditions
Infantile colic.
Disorders of other specified digestive organs in diseases classified elsewhere
Registration Number
IRCT201409015330N8
Lead Sponsor
VICE-CHANCELLOR FOR RESEARCH OF TABRIZ UNIVERCITY OF MEDICAL SCIENCES
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
60
Inclusion Criteria

Inclusion criteria :Babies with infantile colic aged 0 to 2 months
Exclusion criteria:malnutrition;using antibiotics;cow's milk protein allergy

Exclusion Criteria

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Daily time crying. Timepoint: Baseline,week2,week4. Method of measurement: Mother report.;Sleep duration. Timepoint: Baseline,week2,week4. Method of measurement: Mother report.;Feeding changes. Timepoint: Baseline,week2,week4. Method of measurement: mother report.;Defication frequency. Timepoint: Baseline,week2,week4. Method of measurement: Mother report.
Secondary Outcome Measures
NameTimeMethod
Pediatric visits. Timepoint: Baseline,week2,week4. Method of measurement: Mother report.;Emergency department accesses. Timepoint: Baseline,week2,week4. Method of measurement: Mother report.;Loss of parents working days. Timepoint: Baseline,week2,week4. Method of measurement: Mother report.;Use of multiple drugs. Timepoint: Baseline,week2,week4. Method of measurement: Mother report.
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