Status:

UNKNOWN

Efficacy of Zinc Sulfate With Probiotics for the Treatment of Acute Diarrhea in Children

Lead Sponsor:

University Hospital No 1 Wroclaw

Conditions:

Acute Watery Diarrhoea

Eligibility:

All Genders

1-36 years

Phase:

PHASE2

Brief Summary

Diarrheal disease is one of the major causes of morbidity and mortality in children under five. Disease is treated symptomatically with oral rehydration (ORS) as a basic measure. In children with seve...

Detailed Description

A double-blind, placebo controlled trial \- We are going to enroll 256 patients (aged \> 1 months to 36 months) with acute watery diarrhea defined as 3 d or more watery stools per day lasting not les...

Eligibility Criteria

Inclusion

  • Age 1-36 months
  • Acute diarrhea defined as 3 or more watery stools per day
  • Informed consent (parents)

Exclusion

  • Severe dehydration (\> 10%)
  • Coexisting severe infection (e.g. sepsis, pneumonia, meningitis)
  • Immune deficiency
  • Chronic digestive tract disease (e.g. celiac diseases, food allergy)
  • Antibiotic therapy

Key Trial Info

Start Date :

July 1 2010

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 1 2012

Estimated Enrollment :

256 Patients enrolled

Trial Details

Trial ID

NCT01140074

Start Date

July 1 2010

End Date

June 1 2012

Last Update

June 10 2010

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Szpital im Sw Jadwigi w Trzebicy

Trzebnica, Poland, 55-100

2

Klinika Pediatrii i Chorob Infekcyjnych Akademii Medycznej we Wroclawiu

Wroclaw, Poland, 50-345