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

Last updated: June 9, 2010
Sponsor: University Hospital No 1 Wroclaw
Overall Status: Trial Status Unknown

Phase

2

Condition

Colic

Stomach Discomfort

Bowel Dysfunction

Treatment

N/A

Clinical Study ID

NCT01140074
KB-501/2009
  • Ages 1-36
  • All Genders

Study 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 severe zinc deficiency, diarrhea is common and responds quickly to zinc supplementation. Zinc supplementation may also helpful in diarrheal children without zinc deficiency. Effectiveness of zinc was proven in developing countries but was not in Europe. Objective of our study is to assess whether zinc supplementation given with probiotics and ORS is effective in acute diarrhea in children in Poland.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 1-36 months

  • Acute diarrhea defined as 3 or more watery stools per day

  • Informed consent (parents)

Exclusion

Exclusion Criteria:

  • 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

Study Design

Total Participants: 256
Study Start date:
July 01, 2010
Estimated Completion Date:
June 30, 2012

Study 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 less than 1 day and not longer than 5 days.

Exclusion criteria:

severe dehydration (> 10%) Coexisting severe infection (E.g. Sepsis, pneumonia, meningitis) Immune deficiency Chronic digestive tract disease (e.g. celiac diseases, food allergy) Therapy with Antibiotics

Patients will be randomly assigned to 2 groups to receive: (a) zinc sulfate 10-20 mg/day for 10 days plus probiotics for 5 days (b) placebo for 10 days plus probiotics for 5 days. Patients will be observed in ambulatory or in the hospital (if necessary) and followed up for 15 days.

Randomization 1:1

Connect with a study center

  • Szpital im Sw Jadwigi w Trzebicy

    Trzebnica, 55-100
    Poland

    Site Not Available

  • Klinika Pediatrii i Chorob Infekcyjnych Akademii Medycznej we Wroclawiu

    Wroclaw, 50-345
    Poland

    Site Not Available

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