Main goals: The effect of Mesalamine on immune biomarker in IBS in comparison with placebo. Inclusion criteria: 1-Consent to participate in the study and signing the consent form; 2- being at the age of 18 years and older. Exclusion criteria: 1 - Pregnancy or breast feeding; 2 - not using appropriate contraceptive methods; 4 - Use of corticosteroids, antibiotics, mast cell stabilizing drugs, NSAIDs; 5- Large abdominal surgery; 6 - Celiac disease (positive Anti TTG and Anti EndomysialAb); 7 - specific allergic diseases like asthma (positive family and personal history and positive Anti IGE). Sample size: 29 patients in the intervention group and 29 in the comparison group. Type of study: Double blind randomized Clinical trial. Definition of outcome: we have achieved the goal of therapy in case of significant difference in the number of mucosal mast cells and presence of inflammatory mediators in biopsy of the left colon which is taken before and after the treatment, resolving complaints of IBS patients such as changes in bloating, abdominal pain, urgency of defecation, number of daily bowel movements, stool form and consistency, easy defecation, feeling empty and well being. Patients who are satisfied in at least 50% of the weeks of treatment have responded to treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012072910230N2
Registration date:2012-12-17, 1391/09/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-12-17, 1391/09/27
Registrant information
Name
Homayoon Vahedi
Name of organization / entity
Digestive Disease Research Center ,Tehran University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8241 5104
Email address
vahedi@ams.ac.ir
Recruitment status
Recruitment complete
Funding source
Digestive and Liver Disease Research Center, Shariati Hospital
Expected recruitment start date
2011-03-21, 1390/01/01
Expected recruitment end date
2013-06-20, 1392/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Mesalamine effects on mucosal immune biomarkers in irritable bowel syndrome with diarrhea-predominant symptoms
Public title
Mesalamine effects on mucosal immune biomarkers in irritable bowel syndrome with diarrhea-predominant symptoms
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1- Consent to participate in the study and signing the consent form; 2 - being at the age of 18 years and older. Exclusion criteria: 1 - Pregnancy or breast feeding; 2 - not using appropriate contraceptive methods; 3 - the use of NSAIDs; 4 - Use of corticosteroids, antibiotics, mast cell stabilizing drugs; 5- Large abdominal surgery; 6 - Celiac disease (positive Anti TTG and Anti Endomysial Ab); 7 - specific allergic diseases like asthma (positive family and personal history and positive Anti IGE); 8 - organic or psychological disorders characterized by history and specific laboratory tests; 9 - lack of cooperation in implementation of the Study.
Age
From 18 years old to 90 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
58
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
Tehran University of Medical Sciences
Street address
the sixth floor of the Central University, Ghods st., Keshavarz Blvd
City
Tehran
Postal code
1417613151
Approval date
2012-10-20, 1391/07/29
Ethics committee reference number
91/د/210/14833
Health conditions studied
1
Description of health condition studied
Irritable bowel syndrome
ICD-10 code
K58.0
ICD-10 code description
Irritable bowel syndrome with diarrhoea
Primary outcomes
1
Description
Mucosal biomarkers
Timepoint
Before the study and at the end of study
Method of measurement
Sample Pathology
2
Description
Symptoms (diarrhea - abdominal pain - bloating - urgency - the number of bowel movements per day)
Timepoint
Baseline, during and at the end of intervention
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Number of mast cell
Timepoint
Beginning and end of the intervention
Method of measurement
Sample pathology
2
Description
IHC CD117
Timepoint
Beginning and end of the intervention
Method of measurement
Sample pathology
3
Description
Gastrointestinal side effects (diarrhea - bloating - constipation)
Timepoint
Initially, during and end of treatment
Method of measurement
Questionnaire
Intervention groups
1
Description
Mesalamine 800 mg three times a day for 2 months
Category
Treatment - Drugs
2
Description
placebo 3 times daily
Category
Treatment - Drugs
3
Description
Colonoscopy and biopsy at baseline and end of treatment
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Dr. Mehri Pouradineh
Street address
North Kargar St.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Digestive and Liver Disease Research Center, Shariati Hospital
Full name of responsible person
Doctor shahin merat
Street address
Shariati Hospital, North Kargar Street, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Digestive and Liver Disease Research Center, Shariati Hospital
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Rossen Darman company
Full name of responsible person
Dr. Heydri
Street address
Head Office, Fourth Floor of No. 33, cross Sarparast and Bozorgmehr
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rossen Darman company
Proportion provided by this source
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
Research Center for Gastroenterology and Liver
Full name of responsible person
Dr. Homayon Vahedi
Position
Associate Professor
Other areas of specialty/work
Street address
Gastrointestinal and Hepatic Research Center, Shariati Hospital, North Kargar Avenue
City
Tehran
Postal code
Phone
+98 21 84901
Fax
Email
vahedi@ams.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Digestive and Liver Disease Research Center, Shariati Hospital
Full name of responsible person
Dr. Homayon Vahedi
Position
Associate Professor
Other areas of specialty/work
Street address
Gastrointestinal and Hepatic Research Center, Shariati Hospital, North Kargar Avenue
City
Tehran
Postal code
Phone
+98 21 84901
Fax
Email
vahedi@ams.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Digestive and Liver Disease Research Center, Shariati Hospital
Full name of responsible person
Dr. mehri pouradineh
Position
internal Assistant
Other areas of specialty/work
Street address
Gastroenterology Research Center, Shariati Hospital
City
Tehran
Postal code
Phone
+98 21 84901
Fax
Email
mehri_pooradineh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)