This study aimed to determine the effectiveness of probiotics in the control of symptoms associated with IBS. A total of sixty IBS patients fulfilling the Rome II criteria took part in this double blind controlled trial. The patients were recruited among those visiting GI clinic of Ardabil Imam Khomeini hospital. Participants were randomly allocated into the intervention or control groups to receive probiotic or normal yogurt for 4 weeks. Bottles of yoghurt were manufactured, and coded by the diary company. IBS related symptoms; abdominal pain and fecal consistency, were evaluated before the treatment and weeks 2, 4 and 6 after the treatment and were compared between the two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201008192032N2
Registration date:2011-05-09, 1390/02/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-05-09, 1390/02/19
Registrant information
Name
Farhad Pourfarzi
Name of organization / entity
Ardabil University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 45 3325 9011
Email address
f.pourfarzi@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ardabil University of Medical Sciences
Expected recruitment start date
2008-04-19, 1387/01/31
Expected recruitment end date
2009-04-20, 1388/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of probiotic Yogurt to Control Symptoms Related to Irritable Bowel Syndrome
Public title
The Effectiveness of probiotic Yogurt to Control Symptoms Related to Irritable Bowel Syndrome
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Abdominal pain or GI discomfort for at least 3 month in a year and 2 of the following symptoms: Pain relief after defecation, Change in frequency of defecation with the onset of the symptoms, Change in fecal consistency with the onset of the symptoms
Exclusion criteria: Celiac disease
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Ardabil University of Medical Sciences
Street address
Ardabil University of Medical Sciences, Ardabil
City
Ardabil
Postal code
Approval date
2008-03-12, 1386/12/22
Ethics committee reference number
15386/43
Health conditions studied
1
Description of health condition studied
Irritable bowel syndrome
ICD-10 code
K58
ICD-10 code description
Irritable bowel syndrome
Primary outcomes
1
Description
Abdominal pain
Timepoint
Before, 2, 4 and 6 weeks after trial
Method of measurement
0=NA, 1=mild, 2=moderate, 3=severe
Secondary outcomes
1
Description
Fecal consistency
Timepoint
Before, 2, 4 and 6 weeks after trial
Method of measurement
Normal, solid, Watery, Mucosal
Intervention groups
1
Description
Intervention group: Bottles contain 100 gr of probiotic yogurt, twice daily for 4 weeks
Category
Treatment - Other
2
Description
Control group: Bottles contain 100 gr of normal yogurt, twice daily for 4 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ardabil Imam Khomeini hospital
Full name of responsible person
Street address
City
Ardabil
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr Mehrdad Mirza Rahimi
Street address
Ardabil University of Medical Sciences
City
Ardabil
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil 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
Ardabil University of Medical Sciences
Full name of responsible person
Farhad Pourfarzi
Position
PhD / Assistant professor
Other areas of specialty/work
Street address
Ardabil University of Medical Sciences, Ardabil
City
Ardabil
Postal code
Phone
+98 45 1552 2100
Fax
Email
f.pourfarzi@arums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Farhad Pourfarzi
Position
Phd/ Assistant professor
Other areas of specialty/work
Street address
Ardabil University of Medical Sciences, Ardabil
City
Ardabil
Postal code
Phone
+98 45 1552 2100
Fax
Email
f.pourfarzi@arums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)