This study will be conducted to determine the effect of yeast probiotic (saccharomyces boulardii) on acute diarrhea in children. Inclusion criteria : existence of acute diarrhea (watery diarrhea 3 times or more/ day that last less than 14 days); mild and moderate dehydration; age between 2-5 years ; Failure to receive antibiotics and probiotic compounds in the past 1 month . Exclusion criteria: chronic diarrhea; malabsorption diseases ( such as dairy and gluten intolerance such as bread , barley and oat); dysentery( diarrhea with visible blood); accompanying disease (such as diabetes, malnutrition, celiac, dairy intolerance); severe dehydration ( more than 9%); abdominal distention; suspected to intestinal obstruction ; vomiting. In this study, two groups of case and control (each group 30 patients) affected with acute diarrhea will be evaluated. The total of patients that will be evaluated are 60 patients. The case group will receive yeast probiotic saccharomyces boulardii (trade name yomog cap) and control group will receive placebo(Chickpea flour powder). Intervention time will be from 22/11/2017 until 21/9/2018. The Primary outcome including frequency of diarrhea will be compared between groups.
General information
Acronym
yeast probiotic (saccharomyces boulardii) and acute diarrhea
IRCT registration information
IRCT registration number:IRCT2017090812897N3
Registration date:2017-10-07, 1396/07/15
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-10-07, 1396/07/15
Registrant information
Name
Abolfazl Mahyar
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28133348089
Email address
amahyar@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Department of Qazvin University of Medical Sciences
Expected recruitment start date
2017-11-22, 1396/09/01
Expected recruitment end date
2018-09-21, 1397/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of yeast probiotic (saccharomyces boulardii) on acute diarrhea in children
Public title
The effect of yeast probiotic (saccharomyces boulardii) on acute diarrhea in children
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: existence of acute diarrhea; mild and moderate dehydration; age between 2-5 years ; Failure to receive antibiotics and probiotic compounds in the past 1 month . Exclusion creteria: chronic diarrhea; malabsorption diseases ;dysentery;accompanying diseasesuch as diabetes; severe dehydration ;abdominal distention; suspected to intestinal obstruction; vomiting )
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:
60
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
ethics committee of Qazvin University of Medical Sciences
Street address
Bolvar Shahid Bahonar,Qazvin University of medical sciences-Qazvin
City
Qazvin
Postal code
59811-34197
Approval date
2017-09-02, 1396/06/11
Ethics committee reference number
IR.QUMS.REC.1396.239
Health conditions studied
1
Description of health condition studied
Acute diarrhea
ICD-10 code
A03
ICD-10 code description
Shigellosis
Primary outcomes
1
Description
frequency of diarrhea
Timepoint
before intervention, afterintervention
Method of measurement
questionnaire
Secondary outcomes
1
Description
duration of diarrhea
Timepoint
before intervention, after intervention
Method of measurement
questionnaire
Intervention groups
1
Description
The case group will be receive cap Yomogi (contains 250 mg dried yeast Saccharomyces boulardii) as a single dose per day. Cap Yomogi is produced by ARDEYPHARM GmbH company under the license No. 640920, Herdecke , Germany. For easier eating of probiotics the content of cap yomogi will be dissolved in 10 ml of water.
Category
Treatment - Drugs
2
Description
The control group will receive Chickpea flour powder as a single dose per day. Chickpea flour powder is produced by Tarkhineh Company under the license No. 640920 and Operation license No.81, Tehran, Iran. For easier eating, the Chickpea flour powder will be dissolved in 10 ml of water. The color ,taste and volume of Chickpea flour powder will be similar of cap Yomogi.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Qods hospital
Full name of responsible person
Abolfazl Mahyar
Street address
Valiasr square-Qods hospital
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Zahra Shamekhi
Street address
Research Department-Medical College-Qazvin University of Medical Sciences
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences, Qazvin
Full name of responsible person
Abolfazl Mahyar
Position
Pediatrician-professor
Other areas of specialty/work
Street address
Valiasr Square-Qods Hospital
City
Qazvin
Postal code
3415914595
Phone
+98 28 3334 4087
Fax
Email
amahyar@qums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Siences
Full name of responsible person
Abolfazl Mahyar
Position
Pediatrician-professor
Other areas of specialty/work
Street address
Valiasr Square-Qods Hospital
City
Qazvin
Postal code
3415914595
Phone
+98 28 3334 4087
Fax
+98 33344087
Email
amahyar@qums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Abolfazl Mahyar
Position
Pediatrician-Professor
Other areas of specialty/work
Street address
Valiasr Square-Qods Hospital
City
Qazvin
Postal code
3415914595
Phone
+98 28 3334 4087
Fax
+98 33344087
Email
amahyar@qums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)