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A comparison between the effect of rifaximin in different doses on symptoms and quality of life improvement in Iranian patients with diarrhea-predominant irritable bowel syndrome, a randomized clinical trial.

Protocol summary

Study aim
A comparison between the effect of rifaximin in different doses on symptoms and quality of life improvement in Iranian patients with diarrhea-predominant irritable bowel syndrome, a randomized clinical trial.
Design
All eligible patients are informed about the study design and after completing the consent form, based on the randomized table, assigned in one of the treatment groups. The total number of patients is 160 patients, with 80 patients in each group.Demographic data were recorded. Questionnaires including IBS-D SSI, QOL and Beck score and Bristole score are recoreded at the beginning and ending the treatment and 4 and 8 weeks after ending the treatments.
Settings and conduct
All eligible patients with diarrhea dominant IBS who are referred to the gastroenterology clinic of Rasoul Akram hospital, after filling informed-consent form, will be randomly assigned into two treatment groups. IBS-D SS Index, IBS-D QoL, Bristol stool scale, Beck anxiety and depression will be completed for all the patients at the beginning, end of treatment, and 4 and 8 weeks after completing the treatment. Data is analyzed by SPPS version 21.
Participants/Inclusion and exclusion criteria
All patients with diarrhea dominant irritable bowel syndrome based on Rome IV criteria with the age 16-70 years
Intervention groups
Control group: 550mg capsule of rifaminin twice a day intervention group : 550mg capsule of rifaminin three times a day
Main outcome variables
Improvement of IBS-D patients' symptoms severity index improvement of IBS-D patients' quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20141201020178N11
Registration date: 2022-04-03, 1401/01/14
Registration timing: registered_while_recruiting

Last update: 2022-04-03, 1401/01/14
Update count: 0
Registration date
2022-04-03, 1401/01/14
Registrant information
Name
Marjan Mokhtare
Name of organization / entity
Iran University of Medical sciences,Rasoul Akram Hospital,Colorectal Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 6652 2845
Email address
mokhtare.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-21, 1400/11/01
Expected recruitment end date
2022-04-08, 1401/01/19
Actual recruitment start date
2022-01-20, 1400/10/30
Actual recruitment end date
2022-04-08, 1401/01/19
Trial completion date
2022-09-20, 1401/06/29
Scientific title
A comparison between the effect of rifaximin in different doses on symptoms and quality of life improvement in Iranian patients with diarrhea-predominant irritable bowel syndrome, a randomized clinical trial.
Public title
The effect of rifaximin in different doses on symptoms and quality of life improvement in Iranian patients with diarrhea-predominant irritable bowel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diarrhea-dominant IBS (IBS-D) patients Patients who are able to follow the study protocol Patients who are available for the entire study period Women and men amongst Iranian population 16-70 years old patients
Exclusion criteria:
All patients with other subclass of IBS Probiotics consumption in the last 3 months Antibiotic therapy in the last 3 months Concomitant systemic disease (malignancy, uncontrolled hypertension, diabetes mellitus, liver, kidney, pulmonary or heart diseases, neurological disorders, psychosis, thyroid dysfunction, lactose intolerance, pregnancy or breastfeeding, inflammatory bowel disease, celiac disease, and gastroduodenal disease) Taking fiber supplements within 2 weeks before starting the study Planning to have surgery during the study time History of alcohol or drug abuse Participating in another clinical trial over the past three months Positive PCR result for covid 19
Age
From 16 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 200
Actual sample size reached: 160
Randomization (investigator's opinion)
Randomized
Randomization description
computer-generated ,simple randomization with interactive web response system(IRS) into two equally-numbered groups
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of iran university of medical science
Street address
Iran University of Medical Sciences, West Shahid Hemmat Highway,Intersection of Chamran and Sheikh Fazlollah Noori
City
tehran
Province
Tehran
Postal code
1449614535
Approval date
2021-06-19, 1400/03/29
Ethics committee reference number
IR.IUMS.FMD.REC.1400.213

Health conditions studied

1

Description of health condition studied
diarrhea predominant irritable bowel syndrome
ICD-10 code
K58.0
ICD-10 code description
Irritable bowel syndrome with diarrhea

Primary outcomes

1

Description
Comparison of improvement in IBS-D patients symptom severity index between treatment groups.
Timepoint
At the beginning of treatment, at the end of treatment, 4 and 8 weeks after completing treatment
Method of measurement
IBS-D symptom severity index questionnaire

2

Description
Comparison of improvement in IBS-D patients quality of life between treatment groups.
Timepoint
At the beginning of treatment, at the end of treatment, 4 and 8 weeks after completing treatment
Method of measurement
IBS-D quality of life questionnaire.

Secondary outcomes

1

Description
comparison of improvement in quality of life
Timepoint
At the beginning, at the end of treatment, 4 and 8 weeks after end of the treatment.
Method of measurement
Bristol stool texture score

2

Description
comparison of improvement in IBS-D anxiety and depression score
Timepoint
At the beginning and end of the treatment
Method of measurement
Beck depression and anxiety score

Intervention groups

1

Description
Control group: 550mg capsule of rifaximin twice a day
Category
Treatment - Drugs

2

Description
Intervention group: 550mg capsule of rifaximin three times in a day
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Gastroenterology department, Rasoul Akram Hospital
Full name of responsible person
Marjan Mokhtare
Street address
Niayesh Street, Sattarkhan Street
City
tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 1000
Email
marjanmokhtare@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hosein Keyvani
Street address
iran university of medical science, hemmat st, tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2504
Email
keyvani.h@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Marjan Mokhtare
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Adult Gastroenterology and Hepatology
Street address
Niayesh Street, Sattarkhan Street
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6655 4790
Email
marjanmokhtare@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical sciences, Rasoul Akram Hospital, Colorectal Research Center
Full name of responsible person
Marjan Mokhtare
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Adult Gastroenterology and Hepatology
Street address
Satarkhan Avenue,Niayesh street
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6652 2845
Fax
+98 21 6650 6864
Email
marjanmokhtare@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Marjan Mokhtare
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Adult Gastroenterology and Hepatology
Street address
Satarkhan Avenue, Niayesh street
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6652 2845
Fax
+98 21 6650 6864
Email
mokhtare.m@iums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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
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