This study is a clinical trial on 90 children aged 2-5 years admitted to pediatric clinic in Kashan Beheshti Hospital with complaints of acute watery diarrhea. Children with high fever (T>38.5°C), severe dehydration, bloody diarrhea, severe malnutrition, using of antibiotics, anti-diarrheal or anti-fungal drugs and patients with more than one complain or Immune deficiency are excluded from the study. Patients randomly assign into three groups. Experimental group1 receive Kidilact as a bacterial probiotic prepared by Zist Khavar Company and experimental group 2 receive Saccharomyces boulardii as a yeast probiotic prepared by Ardegpharm-GmbH and the control group will receive placebo prepared by Farabi Co.Placebo and probiotics have similar color and taste. They receive these products once daily for 5 days. In three groups, treatment protocols for watery acute diarrhea (using ORS) shall be conducted. Frequency and duration of diarrhea within the past 24 hours is recorded by asking mothers.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013031511145N6
Registration date:2013-08-31, 1392/06/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-08-31, 1392/06/09
Registrant information
Name
Mohammad Reza Sharif
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0026
Email address
sharif_m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences
Expected recruitment start date
2013-08-23, 1392/06/01
Expected recruitment end date
2014-05-22, 1393/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of bacterial and yeast probiotics on acute watery diarrhea in children
Public title
The effect of bacterial and yeast probiotics on acute watery diarrhea in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Children admitted to pediatric clinic in Kashan Beheshti Hospital with complaints of acute watery diarrhea; Aged 2 - 5 years. Exclusion criteria: High fever (T>38.5°C); Severe dehydration; Bloody diarrhea; Severe malnutrition; Using of antibiotics, anti-diarrheal or anti-fungal drugs; Patients with more than one complain; Immune deficiency
Age
From 2 years old to 5 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kashan University of Medical Sciences
Street address
5th Kilometer, Ghotbe Ravandi Bulv, Kashan
City
Kashan
Postal code
8715988141
Approval date
2013-08-25, 1392/06/03
Ethics committee reference number
2040/1/5/29پ
Health conditions studied
1
Description of health condition studied
Acute Watery Diarrhea
ICD-10 code
A09.9
ICD-10 code description
Gastroenteritis and colitis of unspecified origin
Primary outcomes
1
Description
Stop Diarrhea
Timepoint
Daily
Method of measurement
Asking from mother
2
Description
Duration of diarrhea
Timepoint
Daily
Method of measurement
Asking from mother
3
Description
Frequency of Diarrhea
Timepoint
Daily
Method of measurement
Asking from mother
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 2:Oral administration of yeast probiotic (Saccharomyces boulardii) daily + ORS
Category
Treatment - Drugs
2
Description
Control group: Oral administration of placebo (like probiotics) daily + ORS
Category
Treatment - Drugs
3
Description
Intervention group 1: Oral administration of bacterial probiotic (Kidilact) daily + ORS