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

University Hospital No 1 Wroclaw

Status and phase: Unknown; Phase 2

Conditions: Acute Watery Diarrhoea

Treatments: Drug: Zinc Sulfate

Study type: Interventional

Funder types: Other

Identifiers

NCT01140074

KB-501/2009

Details and patient eligibility

About

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.

Full 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

Enrollment: 256 estimated patients

Sex: All

Ages: 1 to 36 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

---

256 participants in 2 patient groups, including a placebo group

Zinc sulfate

Experimental group

Description:

Children in active treatment group will be given zinc sulfate 10-20 mg per day orally plus probiotics

Treatment:

Drug: Zinc Sulfate

Placebo

Placebo Comparator group

Description:

Children will be given placebo plus probiotics

Treatment:

Drug: Zinc Sulfate