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

Study Overview
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Brief Summary
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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
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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

Official Title
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Effectiveness and Efficacy of Zinc With Probiotics for the Treatment of Acute Diarrhea in Young Children

Conditions
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Acute Watery Diarrhoea

Intervention / Treatment
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* Drug: Zinc Sulfate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 36 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zinc sulfate<br>Children in active treatment group will be given zinc sulfate 10-20 mg per day orally plus probiotics | Drug: Zinc Sulfate<br>* Zinc Sulfate in sugar sirup will be given orally in dosis of 10-20 mg per day for 10 days<br>* Other names: brand product is not available in Poland;|
| Placebo Comparator: Placebo<br>Children will be given placebo plus probiotics | Drug: Zinc Sulfate<br>* Zinc Sulfate in sugar sirup will be given orally in dosis of 10-20 mg per day for 10 days<br>* Other names: brand product is not available in Poland;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Period of diarrhea in hours | The primary endpoint of our study is the time of acute diarrhea | 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of stools in consequent days | The secondary end points will be number of stools per day, necessity of hospitalization or not, tolerability and adherence to the therapy | 15 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute diarrhoea, children