Clinical efficacy of Mesalazine in patients with diarrhea-dominant irritable bowel syndrome with elevated fecal calprotectin referred to Emam Reza Hospital of Tabriz: a randomized double-blind, placebo-controlled trial
The effect of mesalazine on clinical symptoms and fecal calprotectin levels in patients with irritable bowel syndrome with a predominance of diarrhea and high calprotectin
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 90 patients. For randomization, blockrandomization method is used in two groups of control (n = 45) and drug (n = 45).
Settings and conduct
The present study is a double-blind randomized clinical trial (researcher and patient) that will be performed on patients with irritable bowel syndrome referred to gastrointestinal clinics affiliated to Tabriz University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with irritable bowel syndrome;; diagnosed with Rome IV according to the opinion of a physician; predominant symptoms of patients are diarrhea; normal stool calprotectin level; normal colonoscopy.
Intervention groups
The study groups will receive 500 mg of mesalazine tablets 2 times a day for 8 weeks or placebo for 8 weeks.
Main outcome variables
Abdominal pain; bloating; Diarrhea; use of mesalazine
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151106024901N5
Registration date:2021-08-24, 1400/06/02
Registration timing:retrospective
Last update:2021-08-24, 1400/06/02
Update count:0
Registration date
2021-08-24, 1400/06/02
Registrant information
Name
Seyyed Mehdi Rasoolimanesh
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0021
Email address
m_rasulimanesh@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-20, 1399/11/01
Expected recruitment end date
2021-02-18, 1399/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical efficacy of Mesalazine in patients with diarrhea-dominant irritable bowel syndrome with elevated fecal calprotectin referred to Emam Reza Hospital of Tabriz: a randomized double-blind, placebo-controlled trial
Public title
Clinical efficacy of Mesalazine in patients with diarrhea-dominant irritable bowel syndrome with elevated fecal calprotectin referred to Emam Reza Hospital of Tabriz: a randomized double-blind, placebo-controlled trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with IBS-D according to ROME IV criteria (Loose and watery stool at at least 25% and hardy stool less than 25% of bowel movement)
Age over 18 years
Predominant symptom of diarrhea
Calprotectin levels above 50 feces
Normal colonoscopy during the last 5 years
Exclusion criteria:
Pregnancy and lactation and those who plan to become pregnant
History of major abdominal surgery other than appendectomy and cholecystectomy
A history of allergic disease such as asthma in yourself or a first-degree relative
Celiac disease
History of known psychological disease
Consumption of anti-inflammatory drugs (corticosteroids, NSAIDs), mast cell stabilizers and antibiotics in the last 3 months
History of inflammatory bowel disease or ulcerative colitisSensitivity to sulfur-containing compounds such as mesalazine
Consumption of lactulose and recent probiotics
Evidence of organic disease in colonoscopy
Normal stool calprotectin
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: simple. Randomization unit: individual. Randomization tool: sealed envelope
َThe researcher assigned individuals into two groups using lottery (selecting sealed envelopes, with a card with the letters M or C inside them).
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the patient and the researcher are kept blind. In this way, the safety and data monitoring committee know whether it is a placebo or a drug, and the researcher and the patient do not know the type of group. In this regard, the drug and the placebo will be packed in the same boxes. The drug and placebo will be packaged and delivered by the committee in separate envelopes, and the researcher will divide the patients into two groups, by giving envelope A or envelope B.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of tabriz University of Medical Sciences
Street address
Imam Reza Hospital, Golgasht St., Daneshgah St., Tabriz, East Azerbaijan Province
City
tabriz
Province
East Azarbaijan
Postal code
51666 14756
Approval date
2020-11-09, 1399/08/19
Ethics committee reference number
IR.TBZMED.REC.1399.786
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 and 8 weeks after the intervention
Method of measurement
visual analog scale (0=no pain; 10= worst pain)
2
Description
bloating
Timepoint
Before and 8 weeks after the intervention
Method of measurement
Based on a questionnaire
3
Description
Diarrhea
Timepoint
Before and 8 weeks after the intervention
Method of measurement
Based on the prepared questionnaire, the number of diarrhea per day will be measured.
4
Description
Consumption of mesalazine
Timepoint
Before and 8 weeks after the intervention
Method of measurement
Based on a questionnaire
5
Description
Fecal calprotectin levels
Timepoint
Before and 8 weeks after the intervention
Method of measurement
ELISA method with laboratory kit (calprest)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 500 mg mesalazine tablets 2 times a day for 8 weeks and patients 'clinical manifestations will be evaluated by a physician.
Category
Treatment - Drugs
2
Description
Control group: received placebo 2 times a day for 8 weeks and patients 'clinical manifestations will be evaluated by a physician.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz University of Medical Sciences Imam Reza hospital
Full name of responsible person
Seyed Mehdi Rasoulimanesh
Street address
Imam Reza hospital, Golgasht Street, University Street
City
Tabriz
Province
East Azarbaijan
Postal code
51666 14756
Phone
+98 41 3337 3993
Email
m_rasulimanesh@kaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohhammad Samiei
Street address
Golgasht Street,University Street
City
Tabriz
Province
East Azarbaijan
Postal code
51666 14756
Phone
+98 41 3335 7310
Email
samiei.moh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Seyyed Mehdi Rasoolimanesh
Position
Subspecialized assistant
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Golgasht Street,University Street
City
Tabriz
Province
East Azarbaijan
Postal code
51666 14756
Phone
+98 31 5554 0021
Fax
+98 31 5554 0021
Email
m_rasulimanesh@kaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Seyyed Mehdi Rasoolimanesh
Position
Subspecialized assistant
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Golgasht Street,University Street
City
Tabriz
Province
East Azarbaijan
Postal code
51666 14756
Phone
+98 31 5554 0021
Fax
+98 31 5554 0021
Email
m_rasulimanesh@kaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Seyyed Mehdi Rasoolimanesh
Position
Subspecialized assistant
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Golgasht Street,University Street
City
Tabriz
Province
East Azarbaijan
Postal code
51666 14756
Phone
+98 31 5554 0021
Fax
+98 31 5554 0021
Email
m_rasulimanesh@kaums.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
There is no more information.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available