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

Phase 2

• Conditions: Acute Watery Diarrhoea
• Interventions: Drug: Zinc Sulfate

• Registration Number: NCT01140074
• Lead Sponsor: University Hospital No 1 Wroclaw

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 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.

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 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

Study Timeline

• Status Verified: 2010-06
• Study First Submitted: 2010-06-07
• Study First Submitted QC: 2010-06-07
• Study First Posted: 2010-06-09
• Last Update Submitted: 2010-06-09
• Last Update Posted: 2010-06-10
• Study Start: 2010-07
• Primary Completion: 2012-06
• Study Completion: 2012-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 256

Inclusion Criteria

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

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

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Placebo	Zinc Sulfate	Children will be given placebo plus probiotics
Zinc sulfate	Zinc Sulfate	Children in active treatment group will be given zinc sulfate 10-20 mg per day orally plus probiotics

Primary Outcome Measures

Name	Time	Method
Period of diarrhea in hours	15 days	The primary endpoint of our study is the time of acute diarrhea

Secondary Outcome Measures

Name	Time	Method
number of stools in consequent days	15 days	The secondary end points will be number of stools per day, necessity of hospitalization or not, tolerability and adherence to the therapy

Trial Locations

Locations (2)

Klinika Pediatrii i Chorob Infekcyjnych Akademii Medycznej we Wroclawiu; 🇵🇱 Wroclaw, Poland

Szpital im Sw Jadwigi w Trzebicy; 🇵🇱 Trzebnica, Poland