Investigating the effect of rifaximin tablets on quality of life and symptoms of irritable bowel syndrome
Design
Randomization in this study will be done using block randomization method with online software in 29 blocks of 6.
Settings and conduct
This study will be conducted as a randomized clinical trial in Amir al-Momenin Hospital in Arak, on patients with irritable bowel syndrome. In this study, the quality of life questionnaire is filled before starting the treatment, and after taking the medicine for two weeks, the questionnaire is filled and the recovery rate of the patients is checked. This study will be conducted in a double-blind manner, and patients and clinical caregivers and outcome assessors will not know the type of study groups.
Participants/Inclusion and exclusion criteria
Normal body mass index (18-25)
Absence of any organic intestinal disease and intestinal infection
Absence of any major intestinal surgery
Not taking laxatives or antidiarrheal drugs regularly
Lack of medical history of gastrointestinal and colorectal diseases and absorption
Lack of regular use of antibiotics and corticosteroids and immunosuppressive drugs
Not taking drugs that increase bleeding from intestinal mucus such as aspirin, warfarin
Absence of severe mental and behavioral disorder
Not being pregnant or breastfeeding, being an athlete or being hospitalized
Not taking non-steroidal anti-inflammatory drugs
Absence of breast cancer in the person himself or first degree relatives
Intervention groups
In this research, 30 patients with irritable bowel syndrome are selected and receive rifaximin drug for two weeks, and the control group, 30 patients received placebo drug for two weeks, and after that, all patients using The quality of life questionnaire of irritable bowel syndrome patients will be examined.
Main outcome variables
Quality of life, Clinical symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221211056775N1
Registration date:2022-12-18, 1401/09/27
Registration timing:prospective
Last update:2022-12-18, 1401/09/27
Update count:0
Registration date
2022-12-18, 1401/09/27
Registrant information
Name
Yasin ََAziminezhad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3367 3552
Email address
yassazzim74@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-10, 1401/10/20
Expected recruitment end date
2023-02-09, 1401/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of rifaximin tablets on the quality of life and symptoms of irritable bowel syndrome in patients
Public title
The effect of rifaximin in IBS
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Normal body mass index (18-25)
Absence of any organic intestinal disease (diagnosis based on colonoscopy in the last 5 years) and absence of any intestinal infection (diagnosis based on stool culture)
Absence of any major intestinal surgery
Not taking laxatives or antidiarrheal drugs regularly
Lack of medical history of gastrointestinal and colorectal diseases and absorption
Lack of regular use of antibiotics and corticosteroids and immunosuppressive drugs
Not taking drugs that increase bleeding from intestinal mucus such as aspirin, warfarin
Absence of severe mental and behavioral disorder
Not being pregnant or breastfeeding, being an athlete or being hospitalized
Not taking non-steroidal anti-inflammatory drugs
Absence of breast cancer in the person herself or first degree relatives
Exclusion criteria:
Taking rifaximin tablets from one year before entering the study and changing the diet during the study
Failure to continue the study due to drug side effects
Reluctance to cooperate
Pregnancy during study
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
This study will be conducted in a double-blind manner. In this way, participating patients and clinical caregivers and outcome assessors are not aware of the study groups and know them only based on the letters A and B. Of course, the main researcher and data analyst are aware of the studied groups and the interventions performed in them.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Student Research Committee , Arak University of Medical Sciences , Arak ,Iran
Street address
Arak, University Street, Modares Street, Yas dead end
City
Arak
Province
Markazi
Postal code
3817915193
Approval date
2022-10-23, 1401/08/01
Ethics committee reference number
IR.ARAKMU.REC.1401.212
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
Quality of life
Timepoint
Two weeks before and two weeks after the intervention
Method of measurement
Specific quality of life questionnaire for patients with irritable bowel syndrome (IBS_QOL)
2
Description
Clinical symptoms
Timepoint
Two weeks before and two weeks after the intervention
Method of measurement
Clinical interview
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 30 patients fill out the questionnaire related to the quality of life of irritable bowel syndrome 2 weeks before starting to take rifaximin tablets and record the symptoms they had before starting the drug. Since the beginning of the study, rifaximin 550 mg tablets (Kowsar-Iran) have been taken orally every 12 hours, once a day. Then, 2 weeks after taking the drug, they fill out the quality of life questionnaire again.
Category
Treatment - Drugs
2
Description
Control group: 30 patients fill out the irritable bowel syndrome quality of life questionnaire 2 weeks before starting the placebo pill and record the symptoms they had before starting the drug. Since the beginning of the study, placebo pills, similar to the medicine of the intervention group, have been taken orally every 12 hours, one tablet per day. Then, 2 weeks after taking the drug, they fill out the quality of life questionnaire again.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
َAmir Al-momenin Hospital
Full name of responsible person
Hamidrea Norozi
Street address
University Street, Modares St., dead end, Yas
City
Arak
Province
Markazi
Postal code
3817915193
Phone
+98 86 3367 3552
Email
yassazzim74@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohammadreza Rohani
Street address
University Street, Modares St., dead end, Yas
City
Arak
Province
Markazi
Postal code
3817915193
Phone
+98 86 3367 3552
Email
yassazzim74@gmail.com
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
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
Arak University of Medical Sciences
Full name of responsible person
Yasin Aziminezhad
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
University Street, Modares Street,Yas 4 dead end
City
Arak
Province
Markazi
Postal code
3817915193
Phone
+98 86 3367 3552
Email
yassazzim74@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Yasin Aziminezhad
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
University Street, Modares Street,Yas 4 dead end
City
Arak
Province
Markazi
Postal code
3817915193
Phone
+98 86 3367 3552
Email
yassazzim74@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Yasin Aziminezhad
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
University Street, Modares Street,Yas 4 dead end
City
Arak
Province
Markazi
Postal code
3817915193
Phone
+98 86 3367 3552
Email
yassazzim74@gmail.com
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
No more information.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not 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