Comparison of the effect of synbiotics and zinc in the treatment of acute diarrhea in children
Design
Clinical trial, With parallel group, Without blinding,On 80 patients. Rand function of Excel software was used for randomization.
Settings and conduct
This study was performed on children who were referred to the infectious ward of Qazvin Quds Hospital with a diagnosis of acute diarrhea.
Patients are divided into two groups and group A will be given a sachet containing probiotics daily and group B will be given 5 mg of zinc gluconate syrup every six hours for 10-14 days.
This study is performed without blinding.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- Existence of acute diarrhea (watery or loose stools three or more times in 24 hours for less than 14 days)
2- Existence of mild dehydration and intermediate
3- Age 2-5 years
4- No antibiotic, zinc-containing compounds , Probiotics and synbiotics in the last 1 month
Exclusion criteria:
Children with chronic diarrhea (diarrhea over 14 days), bacterial diarrhea (presence of any number of white blood cells with or without red blood cells in fecal examination with abnormal stool culture), parasitic infections (such as Giardia and amoebae), dehydration Severe (more than 9%), abdominal distension, intestinal obstruction, comorbidities and underlying diseases such as malnutrition and diabetes.
Intervention groups
Group A will be given a sachet of probiotics and prebiotics dissolved in water daily.
Group B will be given 5 mg of zinc gluconate syrup every six hours for 10-14 days
Main outcome variables
1- Determining the average number of daily diarrhea in children receiving synbiotics and zinc
2- Determining the average recovery time of diarrhea in children receiving synbiotics and zinc
3- Determining complications in the group receiving synbiotics and zinc
4. Mean hospital stay in the group receiving synbiotics and zinc
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210523051375N1
Registration date:2021-09-16, 1400/06/25
Registration timing:registered_while_recruiting
Last update:2021-09-16, 1400/06/25
Update count:0
Registration date
2021-09-16, 1400/06/25
Registrant information
Name
banafshe samadpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3333 4807
Email address
rad2180@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-30, 1400/04/09
Expected recruitment end date
2022-06-30, 1401/04/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of synbiotics and zinc in the treatment of acute diarrhea in children
Public title
Evaluation of the effect of synbiotics and zinc in the treatment of acute diarrhea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Existence of acute diarrhea
Existence of mild to moderate dehydration
Not receiving antibiotics, zinc-containing compounds, probiotics and synbiotics in the last 1 month
Exclusion criteria:
Existence of severe dehydration
Children with chronic diarrhea
Bacterial diarrhea
Ileus
Age
From 1 year old to 5 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are assigned to two groups a and b using the balance block method (Balance block randomization). The size of each block is 4.
Balanced randomization allocation method for participants in a randomized clinical trial study is the effect of synbiotics (group a) and zinc (group b) in reducing diarrhea in children .
The tool is random allocation software.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not 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 Science
Control group:Synbiotic، Daily sachet pack containing probiotics and probiotic Kidi Lact(Kidi Lact of Tehran Bio Fermentation Company, which contains 7 probiotics)
Category
Treatment - Drugs
2
Description
Intervention group: Zinc gluconate syrup in the amount of 5 mg every six hours(Zinc gluconate syrup of Amin Isfahan Pharmaceutical Company, which contains 5 mg of zinc element every 5 cc)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Quds Hospital
Full name of responsible person
Banafshe Samadpour
Street address
Valiasr Square, Shahid Beheshti St, Quds Hospital
City
Qazvin
Province
Qazvin
Postal code
3415914595
Phone
+98 28 3333 4807
Email
rad2180@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Research Assistant Quds Hospital
Street address
Valiasr Square, Shahid Beheshti St, Quds Hospital
City
Qazvin
Province
Qazvin
Postal code
3415914595
Phone
+98 28 3333 4807
Email
rad1280@yahoo.com
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
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
Qazvin University of Medical Sciences
Full name of responsible person
Banafshe Samadpour
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Qods Hospital,Qods Square,Qazvin
City
Qazvin
Province
Qazvin
Postal code
3415914595
Phone
+98 28 3333 4807
Fax
Email
Rad2180@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Banafshe Samadpour
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Qods Hospital,Qods Square,Qazvin
City
Qazvin
Province
Qazvin
Postal code
3415914595
Phone
+98 28 3333 4807
Fax
Email
Rad2180@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Banafshe Samadpour
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Qods Hospital,Qods Square,Qazvin
City
Qazvin
Province
Qazvin
Postal code
3415914595
Phone
+98 28 3333 4807
Fax
Email
Rad2180@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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
Title and more details about the data/document
All data can be shared after people are not identified
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Data will be available for researchers working in academic and scientific institutions.
Under which criteria data/document could be used
Any kind of analysis on the delivered data is allowed. Send a message to the author's email to request access to data or documentation.
From where data/document is obtainable
banafshe samadpour - rad2180@yahoo.comnv
What processes are involved for a request to access data/document
After the publication of the article, the applicant is able to access the information by sending an email to the author and its duration is about one month