Determining the effect of probiotics on acute diarrhea in hospitalization children
Design
The study will be double blind and clinical trial.116 patients will be randomly divided into 2 groups. The groups are parallel. The trial phase is 3
Settings and conduct
Children with acute diarrhea admitted to Amir Kabir Hospital in Arak city are divided into 2 groups by simple randomization using the block method. The study is not blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Hospitalized patients with acute diarrhea with moderate dehydration and severe dehydration, non-bloody diarrhea, age between 6 months and 60 months, absence of any history of chronic disease, not taking antibiotics in the last two weeks, lack of immunity, not taking immunosuppressive drugs
Exclusion criteria:Unwillingness to continue studying
Intervention groups
Intervention group:ptients will receive procid capsules containing 3.5 x 109 Lactobacillus acidophilus, 1 x 109 Lactobacillus rhapmosus, 1 x 109 Bifidobacterium bifidium, and maltodextrin .
Control group: ptients will receive serum therapy.
Main outcome variables
Number of times of diarrhea, consistency of stool, duration of hospitalization, duration of diarrhea
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221108056433N1
Registration date:2022-11-26, 1401/09/05
Registration timing:prospective
Last update:2022-11-26, 1401/09/05
Update count:0
Registration date
2022-11-26, 1401/09/05
Registrant information
Name
Mohammadreza Shakoori
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4447 4449
Email address
shakour111@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-01, 1401/09/10
Expected recruitment end date
2023-12-01, 1402/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determining the effect of probiotics on acute diarrhea in hospitalization children
Public title
Determining the effect of probiotics on acute diarrhea in hospitalization children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Hospitalized patients with acute diarrhea with moderate dehydration
Hospitalized patients with acute diarrhea with severe dehydration
Non-bloody diarrhea
Age between 6 months and 60 months
Absence of any history of chronic disease
Not taking antibiotics in the last two weeks
Lack of immunity
Not taking immunosuppressive drugs
Exclusion criteria:
Unwillingness to continue studying
Age
From 6 months old to 60 months old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
116
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be allocated into 2 groups using a permuted balanced block randomization method with the size of blocks 4 and 8. Random sequence will be generated by an epidemiologist by running an online program in sealed envelope website (https://www.sealedenvelope.com/). Random chain concealment is done by opaque envelope method.
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 cComittee of Arak University of Medical Sciences
Street address
Ethics comittee, Research center, Payambar Azam complex, Basij squre ,Sardasht,Arak
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2022-09-04, 1401/06/13
Ethics committee reference number
IR.ARAKMU.REC.1401.180
Health conditions studied
1
Description of health condition studied
Acute diarrhea
ICD-10 code
K52.9
ICD-10 code description
Noninfective gastroenteritis and colitis, unspecified
Primary outcomes
1
Description
Number of times of diarrhea
Timepoint
Before and after treatment
Method of measurement
Physical examination
2
Description
Consistency of stool
Timepoint
Before and after treatment
Method of measurement
Physical examination
3
Description
Duration of hospitalization
Timepoint
Duration study
Method of measurement
Observation
4
Description
Duration of diarrhea
Timepoint
Duration study
Method of measurement
Physical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: ptients will receive procid capsules containing 3.5 x 109 Lactobacillus acidophilus, 1 x 109 Lactobacillus rhapmosus, 1 x 109 Bifidobacterium bifidium, and maltodextrin.
Category
Treatment - Drugs
2
Description
Control group: ptients will receive serum therapy.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amirkabir hospital
Full name of responsible person
Dr Mojtaba Hashemi
Street address
Amirkabir hospital, Parastar square, Arak
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 912 250 3276
Email
mojtaba53hashemi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Mehdi Salehi
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
salegi@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Dr Nooshin Sajadi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Amirkabir hospital, Parastar square, Arak
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Email
mojtaba53hashemi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Mojtaba Hashemi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Amirkabir hospital, Parastar square, Arak
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Email
mojtaba53hashemi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohammadreza Shakoori
Position
Resident of infant
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
No.46, East Ordibehesht, Sardarejangal, Tehran
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 21 4447 4449
Fax
Email
shakour111@gmail.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