Clinical trial NCT01140074: Efficacy of Zinc Sulfate With Probiotics for the Treatment of Acute Diarrhea in Children
Official title: Effectiveness and Efficacy of Zinc With Probiotics for the Treatment of Acute Diarrhea in Young Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Acute Watery Diarrhoea
Keywords: acute diarrhoea, children
Lead sponsor: University Hospital No 1 Wroclaw
Sponsor class: OTHER
First posted: 2010-06-09
Enrollment: 256
Sex: ALL
Minimum age (years): 1
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Period of diarrhea in hours
timeFrame: 15 days
Secondary outcomes:
measure: number of stools in consequent days
timeFrame: 15 days
Other outcomes:
Locations:
city: Trzebnica
country: Poland
facility: Szpital im Sw Jadwigi w Trzebicy
city: Wroclaw
country: Poland
facility: Klinika Pediatrii i Chorob Infekcyjnych Akademii Medycznej we Wroclawiu
Study officials:
affiliation: Wroclaw Medical University
name: Leszek Szenborn, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Fajolu IB, Emokpae A, Oduwole AO, Silva BO, Abidoye RO, Renner JK. Zinc supplementation in children with acute diarrhoea. Nig Q J Hosp Med. 2008 Apr-Jun;18(2):101-3. doi: 10.4314/nqjhm.v18i2.44997.
citation: Boran P, Tokuc G, Vagas E, Oktem S, Gokduman MK. Impact of zinc supplementation in children with acute diarrhoea in Turkey. Arch Dis Child. 2006 Apr;91(4):296-9. doi: 10.1136/adc.2005.079939. Epub 2005 Dec 14.
citation: 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. doi: 10.1136/adc.77.3.196.