Determining the effect of probiotics in comparison with placebo on the duration of diarrhea in patients with acute colitis
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 2 on 94 patients. Data analysis was performed using SPSS 22 statistical software.
Settings and conduct
This study conducted in Abuzar Hospital in Ahvaz. It is also a double-blind study. Probiotic powder and placebo are similar in appearance, taste and smell. Probiotic and placebo are quite similar. Were placed in packages sterile and assigned unit codes to each package. The patient delivering the drug to the patient and filling out the questionnaires were unaware of the type of drug in the package.
Participants/Inclusion and exclusion criteria
inclusion criteria:
Patients admitted to the hospital for 3 months to 14 years due to acute infectious colitis are included in the study.
The diagnosis of colitis is made by an emergency physician and patients who have fever and watery stools more than 3 times a day and less than 14 days have passed since the onset of the disease and with dysentery or the presence of more than 5 WBCs and any number of RBCs in the stool test. It is considered as colitis.
Exclusion criteria: immunodeficiency, severe abdominal distension, severe infection or sepsis, or a history of gastrointestinal surgery or use of antibiotics or probiotics in the last two weeks, and patients who have been hospitalized due to oral intolerance or lack of response to treatment. The need for antibiotics other than azithromycin will be excluded.
Intervention groups
94 patients were enrolled in the study. Patients were randomly divided into two groups of intervention and control. Received a probiotic capsule brand under the brand name yomogi 250.
Main outcome variables
Duration of diarrhea, Vesikari score,duration of hospitalization
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161026030525N2
Registration date:2020-09-13, 1399/06/23
Registration timing:retrospective
Last update:2020-09-13, 1399/06/23
Update count:0
Registration date
2020-09-13, 1399/06/23
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3444 3055
Email address
alizadeh.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-07-05, 1395/04/15
Expected recruitment end date
2018-09-22, 1397/06/31
Actual recruitment start date
2016-08-22, 1395/06/01
Actual recruitment end date
2019-08-22, 1398/05/31
Trial completion date
2019-08-27, 1398/06/05
Scientific title
Efficacy of oral probiotic in reducing of duration of diarrhea in children with acute colitis: a double blind randomized placebo controlled trial
Public title
Efficacy of oral probiotic in reducing of duration of diarrhea in children with acute colitis: a double blind randomized placebo controlled trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria:Patients 3 months to 14 years of age admitted to the hospital due to acute infectious colitis.
Patients with fever and watery stools more than 3 times a day and less than 14 days after the onset of the disease
Dysentery or the presence of more than 5 WBCs and any number of RBCs in the stool test
Exclusion criteria:
Immunodeficiency
Severe abdominal distension
Severe infection or sepsis
History of gastrointestinal surgery
Use of antibiotics or probiotics in the last two weeks
Patients who have been hospitalized due to oral intolerance or lack of response to treatment The need for antibiotics other than azithromycin.
Age
From 3 months old to 14 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
94
Actual sample size reached:
94
Randomization (investigator's opinion)
Randomized
Randomization description
Assignment of patients to each intervention and control groups will be done using winpepi software (random block method) and using six blocks.
Blinding (investigator's opinion)
Double blinded
Blinding description
Probiotic powder and placebo are similar in appearance, taste and smell. Probiotics and placebo, which are completely similar, were placed in packages in a sterile method and assigned a single code to each package. The patient and the questionnaire filler were unaware of the type of drug in the package.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan Blvd. Ahvaz Jundishapur University of Medical Sciences - School of Medicine
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2016-04-23, 1395/02/04
Ethics committee reference number
IR.AJUMS.REC.1395.54
Health conditions studied
1
Description of health condition studied
Acute colitis
ICD-10 code
A09.0
ICD-10 code description
Other and unspecified gastroenteritis and colitis of infectious origin
Primary outcomes
1
Description
Duration of diarrhea
Timepoint
Before the intervention. The first day. The third day. The fifth day.
Method of measurement
Day
Secondary outcomes
1
Description
Frequency of diarrhea
Timepoint
Before the intervention. The first day. The third day. The fifth day.
Method of measurement
Number of times of diarrhea per day
2
Description
Duration of vomiting
Timepoint
Before the intervention. The first day. The third day. The fifth day.
Method of measurement
Number of days the patient vomits
3
Description
Frequent vomiting
Timepoint
Before the intervention. The first day. The third day. The fifth day.
Method of measurement
Number of times of vomiting per day
4
Description
Body temperature
Timepoint
Before the intervention. The first day. The third day. The fifth day.
Method of measurement
Maximum temperature every 24 hours
5
Description
Duration of hospitalization
Timepoint
End of hospitalization
Method of measurement
Number of days the patient is hospitalized
Intervention groups
1
Description
Intervention group: Supportive measures including intravenous or oral fluid therapy (ORS solution), antibiotic therapy (azithromycin suspension 12 mg per kg on the first day and then 6 mg per kg daily and the duration of treatment is 5 days). And zinc (zinc sulfate syrup for children under 6 months of age 10 mg daily and over 6 months of age 20 mg daily) in addition to the above treatments bulardi saccharomycesides in the form of probiotic capsules under the brand name yomogi 250. Children over 3 months receive a 250 mg capsule every 12 hours for up to 5 days (15) and in case of vomiting, the drug will be returned to the patient 15 minutes later.
Category
Treatment - Drugs
2
Description
Control group: The control group includes supportive measures including intravenous or oral fluid therapy (ORS solution), antibiotic therapy (azithromycin suspension 12 mg per kg on the first day and then 6 mg per kg daily and the duration of treatment is 5 days). And zinc (zinc sulfate syrup for children under 6 months of age 10 mg daily and over 6 months of age 20 mg daily)
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Abuzar Hospital
Full name of responsible person
Mitra Ahmadi
Street address
Zeytonkarmandi, Blvd. Pasdaran, Tohid St.
City
Ahvaz
Province
Khouzestan
Postal code
6163614175
Phone
+98 61 3444 3051
Fax
+98 61 3444 4711
Email
ahmadi-mi@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Ahvaz Jundishapur University of Medical Sciences of Medical Sciences
Full name of responsible person
Mohamad Badavi
Street address
Golestan Blvd., Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Phone
+98 61 3444 3051
Email
info@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Ahvaz Jundishapur University of Medical Sciences 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
Ahvaz University of Medical Sciences
Full name of responsible person
Mitra Ahmadi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Zaytoun Karmandi, Pasdaran Blvd., Tohid Street
City
Ahvaz
Province
Khouzestan
Postal code
6163614175
Phone
+98 61 3444 3051
Email
ahmadi-mi@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mitra Ahmadi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Zaytoun Karmandi, Pasdaran Blvd., Tohid Street
City
Ahvaz
Province
Khouzestan
Postal code
6163614175
Phone
+98 61 3444 3051
Email
ahmadi-mi@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Masoomeh Alizadeh
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Zaytoun Karmandi, Pasdaran Blvd., Tohid Street
City
Ahvaz
Province
Khouzestan
Postal code
6163614175
Phone
+98 61 3444 3051
Email
Alizadeh.9200@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