To determine the effects of fructo-oligosaccharide and metronidazole on the control of infectious diarrhea in children
Design
In this study, 120 infants with infectious diarrhea who were admitted to Amir al-Momenin Hospital of Zabol were selected. Participants were non-randomly allocated into two intervention groups of 60 participants, and each participant was assigned a code.
Settings and conduct
This double-blind trial was conducted in Amir al-Momenin Hospital of Zabol. The eligible patients were assigned to two intervention groups in a non-randomized manner. The first group received fructo-oligosaccharide, and the second group received metronidazole. Every four hours after the patients received the drugs for the first time, the symptoms of the patients were evaluated.
Participants/Inclusion and exclusion criteria
Main inclusion criteria: Children suffering from infectious diarrhea and age between 60 and 180 months.
Main non-inclusion criteria: Hepatic and renal failure.
Intervention groups
Intervention group 1 (metronidazole): 10 milligrams of metronidazole per kilogram body weight, three times daily until recovery; second intervention group (fructo-oligosaccharide): 10 milligrams of fructo-oligosaccharide per kilogram body weight three times daily until recovery
Main outcome variables
infectious diarrhea
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170316033099N8
Registration date:2019-03-26, 1398/01/06
Registration timing:retrospective
Last update:2019-03-26, 1398/01/06
Update count:0
Registration date
2019-03-26, 1398/01/06
Registrant information
Name
Mohammad Bagher Roozgar
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3239 5680
Email address
roozgar@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-06-22, 1397/04/01
Actual recruitment start date
2017-09-23, 1396/07/01
Actual recruitment end date
2018-06-22, 1397/04/01
Trial completion date
2018-06-22, 1397/04/01
Scientific title
Comparison of the effects of fructo-oligosaccharide and metronidazole on the control of infectious diarrhea in children
Public title
The effect of probiotic and antibiotic drugs on diarrhea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children suffering from infectious diarrhea
Hospitalization in Amir al-Momenin Hospital of Zabol
Age between 60 and 180 months
Informed consent of the child's guardian
Exclusion criteria:
Hepatic failure
Renal failure
Patients with autoimmune disease
Age
From 60 months old to 180 months old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
120
Actual sample size reached:
120
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants and those who collected the data were ignorant of the intervention received.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zabol University of Medical Sciences
Street address
Shahid Rajaei Ave.
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861615881
Approval date
2017-06-21, 1396/03/31
Ethics committee reference number
Zbmu.1.REC.1396.108
Health conditions studied
1
Description of health condition studied
infectious diarrhea
ICD-10 code
A09.0
ICD-10 code description
Other and unspecified gastroenteritis and colitis of infectious origin
Primary outcomes
1
Description
infectious diarrhea
Timepoint
Every four hours from the first drug administration until recovery
Method of measurement
observation
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1 (metronidazole): metronidazole made by Alborz Company, 10 milligrams per kilogram body weight, three times daily until recovery
Category
Treatment - Drugs
2
Description
Intervention group 2 (fructo-oligosaccharide): fructo-oligosaccharide made by Zist-Takhmir Company, 10 milligram per kilogram body weight three times daily until recovery
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir al-Momenin Hospital of Zabol
Full name of responsible person
Dr Mohadeseh Nikbakht
Street address
Zahedan Road
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861615881
Phone
+98 54 3229 5115
Email
mohadeseh_nikbakht@zbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Dr Kaveh Tabrizian
Street address
Shahid Rajaei Ave.
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861615881
Phone
+98 54 3223 0768
Email
Research@zbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zabol 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
Zabol University of Medical Sciences
Full name of responsible person
Dr Mohadeseh Nikbakht
Position
Doctor of Medicine
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Shahid Rajaei Ave.
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861615881
Phone
+98 54 3223 0768
Email
mohadeseh_nikbakht@zbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Dr Mohadeseh Nikbakht
Position
Doctor of Medicine
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Shahid Rajaei Ave.
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861615881
Phone
+98 54 3223 0768
Email
mohadeseh_nikbakht@zbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mohammad Bagher Roozgar
Position
Translator
Latest degree
Master
Other areas of specialty/work
Others
Street address
Ghaffari Ave.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5641
Email
hadirooz@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Deidentified Individual Participant Data Set
When the data will become available and for how long
When the paper extracted from the project is published and for six months
To whom data/document is available
readers of the paper
Under which criteria data/document could be used
Research purposes
From where data/document is obtainable
personal correspondence with the corresponding author
What processes are involved for a request to access data/document