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ROLE OF PROBIOTICS IN MANAGEMENT OF ACUTE DIARRHOEA IN CHILDREN LESS THAN 5 YEARS

Phase 2
Completed
Conditions
Health Condition 1: null- All children aged between 6 months to 5 years with acute diarrhoea ( 7 days duration) visiting the outpatient department or emergency wards will be eligible for inclusion in the study.
Registration Number
CTRI/2011/10/002067
Lead Sponsor
ala Lajpat Rai Memorial Medical College Meerut
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
200
Inclusion Criteria

All children aged between 6 months to 5 years with acute diarrhoea (less than 14 days duration) visiting the outpatient department (OPD) or emergency wards will be eligible for inclusion in the study.

Diarrhoea will be defined if child is having three or more loose stools in the last 24 hours.

Exclusion Criteria

1.Severe malnutrition (Weight for length 3 SD)

2.Dysentery (Presence of visible blood in stools)

3.Clinical evidence of coexisting acute systemic illnesses (meningitis, sepsis, pneumonia)

4.Clinical evidence of chronic disease (e.g. chronic liver disease, chronic renal disease, nephrotic syndrome)

5.Known case of chronic gastrointestinal diseases like celiac disease or inflammatory bowel disease.

6.Use of probiotics in the previous three weeks

7.Use of antibiotics or any antidiarrhoeal medication for the current episode of diarrhoea.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1.Duration of diarrhoea (time in hours from enrolment to the last abnormal (loose or liquid) stool. Last abnormal stool will be defined when the child passes normal stool or no stool for next 24 hours. <br/ ><br>2.Stool consistency as evaluated on a score. Faeces will be graded as 1 (normal), 2 (loose), 3 (semiliquid), and 4 (liquid)5. <br/ ><br>Timepoint: probiotic lactobacillus GG given for 5 days at the dose of 10 billion CFU/day <br/ ><br>
Secondary Outcome Measures
NameTimeMethod
1.Number of loose stools per day during entire episode. <br/ ><br>2.Duration of vomiting. <br/ ><br>3.Duration of hospital stay. <br/ ><br>4.Any adverse effects <br/ ><br>Timepoint: patients is monitored till his diarrhoea is relieved
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