The compare of the effect of yogurt drinking with yogurt and serum therapy in Treatment of acute diarrhea in children aged 1 to 5 years old
Design
In this study, 210 patients with acute diarrhea who have been admitted to the Taleghani hospital in Gorgan, will be selected.Participants will be randomly divided into three groups: yogurt + serum, dough + serum and serum therapy alone ,According to the order of referral to the center. the frequency of diarrhea of the patients will be checked, as well as the time of discharge of patients daily.
Settings and conduct
Children aged 1-5 years old who referred to Taleghani Hospital of Gorgan with acute diarrhea were divided into 3groups that includ 70 childeren in every group: yougurt+ serum, dough + serum and serum alone according to the order of referral, and in these patients, the frequency of diarrhea and the number of days of admission will be checked.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 1-5 years old
Diarrhea
Duration of diarrhea less than 14 days
days
• Exit criteria:
Malnutrition
Diarrhea of non-digestive origin
Chronic diarrhea more than 14 days
Cow's milk protein allergy
Do not accept or tolerate dough or yogurt
Age less than 1 year and more than 5 years
Intervention groups
Patients are divided into three groups:
The first group is the co-recipient of yogurt and common serum therapy
Second group is the co-recipient of dough and common serum therapy
Group 3 is recipient of common serum therapy
Main outcome variables
Diarrhea times
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171211037830N1
Registration date:2018-02-16, 1396/11/27
Registration timing:prospective
Last update:2018-02-16, 1396/11/27
Update count:0
Registration date
2018-02-16, 1396/11/27
Registrant information
Name
Mohammad Sobhani Shahmirzadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3252 8435
Email address
sobhani@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-20, 1396/12/01
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Compare of yogurt and drinking yogurt serum therapy in treatment of acute diarrhea in children 1 to 5 years
Public title
Comparison of the effect of yogurt and Dough with the serum on reducing the frequency of diarrhea in children 1 to 5 years
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 1-5 years old
Diarrhea stool child
Duration of diarrhea less than 14 days
Exclusion criteria:
Malnutrition
Diarrhea of non-digestive origin
Chronic diarrhea more than 14 days
Cow's milk protein allergy
Do not accept or tolerate dough or yogurt
Age less than 1 year and more than 5 years
Age
From 1 year old to 5 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
210
Randomization (investigator's opinion)
Randomized
Randomization description
Regarding the fact that patients were divided into three groups: yogurt, dough and serum, the random allocation method was randomly assigned to the patients in order to receive health care services and randomly the first patient in our group, the second patient in the DOG group The patient was hospitalized in the serum group.
Blinding (investigator's opinion)
Single blinded
Blinding description
Investigating the outcome of intervention, the frequency of diarrhea stools, will be done by one of the nurses working in the department.It will be unaware of the allocation of people in the trilogy and the purpose of the study.In addition, at the analytical stage, the statistical analyst will also keep track of the allocation of people in uninformed groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
کمیته اخلاق منطقه ای دانشگاه علوم پزشکی گلستان
Street address
Hirkan Blvd,Gorgan university of medical sciences
City
Gorgan
Province
Golestan
Postal code
۴۹۳۴۱۷۴
Approval date
2016-10-13, 1395/07/22
Ethics committee reference number
Ir.Goums.REC.1395.270
Health conditions studied
1
Description of health condition studied
Acute Diarrhea
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Diarrhea times
Timepoint
Daily
Method of measurement
Asking from patient or companion
Secondary outcomes
1
Description
Length of hospitalization
Timepoint
Daily
Method of measurement
Asking daily
Intervention groups
1
Description
Intervention group: Intervention group: The first intervention group received yogurt at a rate of 50 cc per kilogram of body weight per day. Second intervention group: Dosages received 150 cc / kg body weight daily.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani children educational center
Full name of responsible person
Dr. Jabbar Parhiz
Street address
Taleghani Hospital, Veterans Boulevard
City
Gorgan
Province
Golestan
Postal code
4916668197
Phone
Fax
Email
drparhiz2014@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Mohammad Reza Honarvar
Street address
Hirkan Blvd, Philosophical Educational Department of Technology Delegation
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3245 1660
Email
honarvar@goums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Fatemeh Iranoost
Position
Assistant Professor of Pediatrics
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Taleghani Hospital, Veterans Boulevard
City
gorgan
Province
Golestan
Postal code
4916668197
Phone
+98 903 876 8859
Email
f1.irandoost@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Mohammad Sobhani Shahmizaii
Position
Pediatric Pediatrician, Faculty of Pediatrics
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Taleghani Hospital, Veterans Boulevard
City
Gorgan
Province
Golestan
Postal code
4916668197
Phone
+98 911 124 5399
Email
sobhani@goums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Fatemeh Iranoost
Position
Assistant Professor of Pediatrics
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Taleghani Hospital, Veterans Boulevard
City
Gorgan
Province
Golestan
Postal code
4916668197
Phone
+98 903 876 8859
Email
f1.irandoost@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available