Acute Watery Diarrhoea
Conditions
Keywords
acute diarrhoea, children
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
Interventions
DRUGZinc Sulfate
Zinc Sulfate in sugar sirup will be given orally in dosis of 10-20 mg per day for 10 days
Sponsors
University Hospital No 1 Wroclaw
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
1 Months to 36 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Period of diarrhea in hours | 15 days | The primary endpoint of our study is the time of acute diarrhea |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Poland
Contacts
Primary ContactLeszek Szenborn, Prof
Backup ContactErnest P. Kuchar, MD
Outcome results
None listed