Clostridium difficile is the most common cause of antibiotic- associated diarrhea (AAD) and antibiotic associated colitis (AAC) in the hospital setting. In this study, the prophylactic effect of probiotic yogurt was investigated on AAC. In this double blind randomized clinical trial study, 132 patients according to our inclusion and exclusion criteria were enrolled to the study and randomly divided into two groups, case (yogurt probiotic, 200mg/day/8 day) and control group (common yogurt). All patients were trained about the signs of colitis. Colitis signs and presence of Clostridium difficile by PCR were recorded and compared between groups. Data were analyzed with appropriate statistical tests and using version 16 of SPSS statistical software.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016092229915N1
Registration date:2016-10-11, 1395/07/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-10-11, 1395/07/20
Registrant information
Name
Elahe Eghbal
Name of organization / entity
Ministry of Health and Educational MedicalArak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 4317 3503
Email address
e.eghbal@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2015-11-22, 1394/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of probiotic yogurt on the prevalence of Clostridium difficile infections in patients hospitalized in arak Vali Asr Hospital
Public title
Evaluation of probiotic yogurt on the prevalence of Clostridium difficile infections
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: persons older than 65 years old admitted in infectious diseases ward who receive antibiotics; no taking antibiotics in the past two months; signed informed consent to participate; no HIV/AIDS; absence of diarrhea during hospitalization.
Exclusion criteria: the patient's unwillingness or inability to enforce orders for the study; discharge before 7 days; need for admission in ICU.
Age
From 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
132
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 Sciences
Street address
Arak University of Medical Sciences, Payambar Azam Complex
City
Arak
Postal code
3848176941
Approval date
2014-07-14, 1393/04/23
Ethics committee reference number
10-165-93
Health conditions studied
1
Description of health condition studied
Clostridium Difficile infections
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Clostridium Difficile
Timepoint
8 days ( during intervention )
Method of measurement
PCR method
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: yoghurt probiotic, 200mg/day/8 day
Category
Treatment - Other
2
Description
Control group: common yughurt, 200mg/day/8 day
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Arak Vali Asr Hospital
Full name of responsible person
Elahe Eghbal
Street address
Arak Vali Asr Hospital, Vali Asr Squ.
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Mohammad Rafiei
Street address
Arak University of Medical Sciences, Payambar Azam Complex
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
Elahe Eghbal
Position
Resident Infectious Diseases
Other areas of specialty/work
Street address
arak University of Medical Sciences, Payambar Azam Complex
City
Arak
Postal code
3848176941
Phone
+98 86 3417 3638
Fax
Email
Rsearch@arakmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Elahe Eghbal
Position
Resident Infectious Diseases
Other areas of specialty/work
Street address
Arak University of Medical Sciences, Payambar Azam Complex
City
Arak
Postal code
3848176941
Phone
+98 86 3417 3638
Fax
+98 86 3417 3639
Email
e.eghbal@arakmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Elahe Eghbal
Position
Resident Infectious Diseases
Other areas of specialty/work
Street address
arak University of Medical Sciences, payambar Azam Complex
City
Arak
Postal code
3848176941
Phone
+98 86 3417 3638
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)