Acute Watery Diarrhoea | Efficacy of Zinc Sulfate With Probiotics for the Treatment of Acute Diarrhea in Children
Acute Watery Diarrhoea research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Acute Watery Diarrhoea
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Zinc SulfateZinc Sulfate in sugar sirup will be given orally in dosis of 10-20 mg per day for 10 days
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Zinc sulfateChildren in active treatment group will be given zinc sulfate 10-20 mg per day orally plus probiotics
PlaceboChildren will be given placebo plus probiotics
Start Date: July 2010
Completed Date: June 2012
Phase: Phase 2
Primary Outcome: Period of diarrhea in hours
Secondary Outcome: number of stools in consequent days
Study sponsors, principal investigator, and references
Principal Investigator: Leszek Szenborn, Prof
Lead Sponsor: University Hospital No 1 Wroclaw
Larson CP, Nasrin D, Saha A, Chowdhury MI, Qadri F. The added benefit of zinc supplementation after zinc treatment of acute childhood diarrhoea: a randomized, double-blind field trial. Trop Med Int Health. 2010 Jun;15(6):754-61. doi: 10.1111/j.1365-3156.2010.02525.x. Epub 2010 Mar 29.
Roy SK, Tomkins AM, Akramuzzaman SM, Behrens RH, Haider R, Mahalanabis D, Fuchs G. Randomised controlled trial of zinc supplementation in malnourished Bangladeshi children with acute diarrhoea. Arch Dis Child. 1997 Sep;77(3):196-200.