Clostridium diffficile is the main cause of diarrhea caused by antibiotics in the hospital system and the aim of this study is to evaluate the role of probiotics in prevention of diarrhea caused by antibiotics. Plan: this is a double-blind case-control study on 300 hospitalized patients who were treated with antibiotic therapy. Methods and Interventions: Patients who needed to receive antibiotics in hospital randomly divide in two case and control groups. Case group will receive two tablets solution containing 150 million spores of Lactobacillus by oral gavage every 12 hours, simultaneously with antibiotics. Patients will receive probiotics during the course of antibiotic therapy and one week after it is cut off. 100 grams of lactose-free milk will gavage two times a day for control group. Inclusion criteria include all patients who need antibiotic therapy in their hospital admission, and exclusion criteria include patients who are initially hospitalized with diarrhea, patients taking antibiotics 4 weeks before admission, patients with neutropenia, patients who had bowel surgery, and patients who have artificial heart valve, or endocarditis. Diarrhea is the primary outcome of this study which is evaluated at the start of the study, in the course of antibiotic therapy and completion of antibiotic treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201107166056N2
Registration date:2011-09-22, 1390/06/31
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-09-22, 1390/06/31
Registrant information
Name
Nader Zarinfar
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1224 1411
Email address
zarinfar@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2011-02-20, 1389/12/01
Expected recruitment end date
2011-08-22, 1390/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of probiotic Lactobacillus to prevent diarrhea caused by antibiotics
Public title
Use of probiotics to prevent diarrhea caused by antibiotics
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who need to receive antibiotics during hospitalization.
Exclusion criteria:
Patients initially admitted with diarrhea.
patients taking antibiotics 4 weeks before admission.
Patients with neutropenia.
Patients who had bowel surgery.
Patients who have artificial heart valves, or endocarditis.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
300
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Arak University Of Medical Science
Street address
Arak, Alamalhoda ave, Arak University of Medical Sciences
City
Arak
Postal code
Approval date
2011-02-07, 1389/11/18
Ethics committee reference number
89-99-3
Health conditions studied
1
Description of health condition studied
diarrhoea
ICD-10 code
K59.1
ICD-10 code description
Functional diarrhoea
Primary outcomes
1
Description
diarrhea
Timepoint
at the start of the study, in the course of antibiotic therapy and completion of antibiotic treatment
Method of measurement
Clinical evaluation
Secondary outcomes
1
Description
Colitis
Timepoint
at the start of the study, in the course of antibiotic therapy and completion of antibiotic treatment
Method of measurement
Clinical evaluation
Intervention groups
1
Description
Case group will receive two tablets solution containing 150 million spores of Lactobacillus by oral gavage every 12 hours, simultaneously with antibiotics.
Category
Treatment - Drugs
2
Description
100 grams of lactose-free milk will gavage two times a day for control group.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Valie-Asr Hospital
Full name of responsible person
Dr nader zarinfar
Street address
Valie-Asr Hospital , Pirozi Ave, Arak
City
Arak
2
Recruitment center
Name of recruitment center
Amiralmomenin hospital
Full name of responsible person
Dr nader zarinfar
Street address
Amiralmomenin hospital, Basij Square,Arak
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr.Davoud Hekmatpou
Street address
Arak University of Medical Sciences , Basij square,Arak
City
Arak
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
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Nader Zarinfar
Position
Infectious disease specialist,Assistant professor
Other areas of specialty/work
Street address
Department of infection disease,Valie-Asr Hospital,Pirozi Ave.Arak
City
Arak
Postal code
3814957558
Phone
+98 86 1224 1411
Fax
+98 86 1224 1411
Email
zarinfar@arakmu.ac.ir
Web page address
portal.arakmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Nader Zarinfar
Position
Assistant professor,Infectious disease specialist
Other areas of specialty/work
Street address
Department of infection disease,Valie-Asr Hospital, Pirozi Ave,Arak
City
Arak
Postal code
3814957558
Phone
+98 86 1224 1411
Fax
+98 86 1224 1411
Email
zarinfar@arakmu.ac.ir
Web page address
portal.arakmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Nader Zarinfar
Position
Assistant professor, Infectious disease specialist
Other areas of specialty/work
Street address
Department of infection disease,Valie-Asr Hospital,Pirozi Ave, Arak
City
Arak
Postal code
3814957558
Phone
+98 86 1224 1411
Fax
+98 86 1224 1411
Email
zarinfar@arakmu.ac.ir
Web page address
portal.arakmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)