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