Acute Watery Diarrhoea Clinical Trial
Official title:
Effectiveness and Efficacy of Zinc With Probiotics for the Treatment of Acute Diarrhea in Young 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
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00325247 -
Efficacy of Zinc Therapy in Acute Diarrhoea in Young Children
|
Phase 3 | |
| Completed |
NCT06179589 -
VS002A in the Treatment of Acute Watery Diarrhea in Infants and Young Children
|
N/A |