Determination of the effects of probiotic yogurt in preventing diarrhea caused by antibiotics in hospitalized patients
Design
In this study, 50 patients with suspected diarrhea following antibiotic use will be entered in the 3rd phase of clinical trial. Participants will be placed in control and intervention groups. Each participant is assigned a code.
Settings and conduct
This study is done Double-blind. Participants and researchers are blind in this study. Participants included patients referring to Ghaem Hospital. Intervention group taking probiotic yogurt, contains lactobacillus and the control group taking normal yogurt . The effects of consumption of yogurt in these two groups are studied and compared.
Participants/Inclusion and exclusion criteria
Inclusion criteria: antibiotic use and patient satisfaction
Exclusion criteria: 1. Severe respiratory infection (severe pneumonia) that the patient should be an NPO
2 - Gastrointestinal diseases such as gastroenteritis and evidence of infectious diarrhea associated with clinical symptoms of fever, accompanied by vomiting and bloody diarrhea
Intervention groups
Control group: control group is given The usual yogurt.
Intervention group: The subjects in the intervention group are given probiotic yogurt containing lactobacillus which will be followed up to 2 weeks after the start of concurrent administration of antibiotics and probiotics.
Main outcome variables
The duration of diarrhea
Frequency of bowel movements
Consistency of stool
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20101107005123N2
Registration date:2018-01-22, 1396/11/02
Registration timing:retrospective
Last update:2018-01-22, 1396/11/02
Update count:0
Registration date
2018-01-22, 1396/11/02
Registrant information
Name
Hamidreza Kianifar
Name of organization / entity
Mashahd University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1801 2469
Email address
kianifarhr@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2013-02-19, 1391/12/01
Expected recruitment end date
2014-02-20, 1392/12/01
Actual recruitment start date
2013-02-19, 1391/12/01
Actual recruitment end date
2014-02-20, 1392/12/01
Trial completion date
empty
Scientific title
The effects of using probiotic yogurt in preventing antibiotic- associated diarrhea
Public title
The Effect of Probiotic Yogurt in Preventing Diarrhea
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Taking antibiotics
patients satisfaction
Exclusion criteria:
Severe respiratory tract infections (severe pneumonia) that the patient should have NPO.
Gastrointestinal diseases such as gastroenteritis and evidence of infectious diarrhea associated with clinical symptoms of fever and associated with vomiting and bloody diarrhea
Age
From 1 year old to 12 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
100
Actual sample size reached:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Using random number table, participants will be randomized in two groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In the project, the participants, as well as the researcher who tracks the patients, are unaware of which group they are and the only one who is aware is the analyzer.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of Mashhad University of Medical Sciences
Street address
Daneshgah Ave, Ghoreishi buildings
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Approval date
2014-06-11, 1393/03/21
Ethics committee reference number
IR.MUMS.REC.1393.104
Health conditions studied
1
Description of health condition studied
antibiotic- associated diarrhea
ICD-10 code
(A00-B99)
ICD-10 code description
Certain infectious and parasitic diseases
Primary outcomes
1
Description
Duration of diarrhea
Timepoint
Before the intervention and 2 weeks later
Method of measurement
Questionnaire
2
Description
Frequency of bowel movements
Timepoint
Before the intervention and 2 weeks later
Method of measurement
Questionnaire
3
Description
Consistency of stool
Timepoint
Before the intervention and 2 weeks later
Method of measurement
Based on the quality of the stool
Secondary outcomes
empty
Intervention groups
1
Description
Control group: This group includes 50 people who take regular yogurt for 2 weeks.
Category
Treatment - Other
2
Description
Intervention group: This group includes 50 people who take probiotic yogurt for 2 weeks.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Dr Ali Jafari
Street address
Ghaem Hospital, Ahmad Abad Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3801 2297
Email
jafaria@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Daneshgah AVE, Ghoreishi Buildings
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3821 2081
Email
ramreasearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Zahra
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Ahmad abad Ave, Ghaem Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3801 2297
Email
Jafaria@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Hamid reza Kianifar
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics Gastroenterologist
Street address
Fakoori Ave, Akbar Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3801 2297
Email
kianifarhr@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hamid Reza Kianifar
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics Gastroenterologist
Street address
Fakoori Ave, Akbar Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3801 2297
Email
Kianifarhr@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The work has not been completed and the study may continue