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Comparison of effectiveness of rifaximin at doses of 1650mg and 2200mg in the treatment of patients with diarrhea-predominant irritable bowel syndrome.

Protocol summary

Study aim
Comparison of effectiveness of rifaximin at doses of 1650mg and 2200mg in the treatment of patients with diarrhea-predominant irritable bowel syndrome.
Design
This is an open-label, parallel, phase III and randomized clinical trial with control group. Randomization is done using SPSS software. The estimated sample size is 150 patients.
Settings and conduct
Place of study: clinic of digestive diseases at Rasoul-e-Akram Hospital, Tehran, Iran; The target population: adult patients with diarrhea-predominant irritable bowel syndrome; Blinding: there is no blinding in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Diarrhea-dominant IBS patients ; who are available for the entire study period; 16-70 years old. Exclusion criteria: other sub-classes of IBS; Antibiotic and probiotics therapy in the last 3 months; inflammatory bowel disease.
Intervention groups
Control group: 550mg capsule of Rifaximin three times a day. Intervention group: 550mg capsule of Rifaximin four times a day.
Main outcome variables
abdominal pain, stool consistency, frequency/urgency in defecation, and the quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20141201020178N12
Registration date: 2023-08-31, 1402/06/09
Registration timing: registered_while_recruiting

Last update: 2023-08-31, 1402/06/09
Update count: 0
Registration date
2023-08-31, 1402/06/09
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
2023-07-23, 1402/05/01
Expected recruitment end date
2023-10-06, 1402/07/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effectiveness of rifaximin at doses of 1650mg and 2200mg in the treatment of patients with diarrhea-predominant irritable bowel syndrome.
Public title
The therapeutic effects of rifaximin in diarrhea-predominant irritable bowel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diarrhea-dominant irritable bowel syndrome (IBS-D) patients based on ROME IV criteria Patients who are available for the entire study period Women and men among Iranian population with more than 16 years old Patients who are able to follow the study protocol
Exclusion criteria:
Mild IBS-D (less than 175 points on the IBS-SSS scale) All IBD subtypes Consumption of Antibiotics or probiotics in the past three months before trial A severe concomitant disease (malignancy, hypertension uncontrolled and diabetes mellitus, liver, kidney or heart disorders, serious neurological disorders, psychosis, respiratory disorders such as asthma, chronic obstructive pulmonary disease, hyperthyroidism or hypothyroidism) Diagnosed lactose intolerance Consumption of motility medications or dietary fiber supplements 2 weeks before the start of the study Planning to undergo surgery during the study period History of alcohol or drug abuse Chronic bowel disorders other than IBS, including inflammatory bowel disease, gastric and duodenal ulcers, celiac disease Participation in another clinical trial within the past three months Positive PCR result for the COVID-19 Pregnancy or breastfeeding
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: 150
Randomization (investigator's opinion)
Randomized
Randomization description
Computer-generated, simple randomization with SPSS software into two equally numbered groups. After recruiting the eligible subjects and dedicating distinctive IDs to each patient, patients will be randomly allocated into two equal groups using the randomization command in SPSS software.
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 Sciences
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
2023-06-11, 1402/03/21
Ethics committee reference number
IR.IUMS.FMD.REC.1402.135

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
Abdominal pain
Timepoint
Before the treatment, at the end of treatment, 4 and 8 weeks after completing treatment
Method of measurement
IBS-D symptom severity index questionnaire

2

Description
Bloating
Timepoint
Before the treatment, at the end of treatment, 4 and 8 weeks after completing treatment
Method of measurement
IBS-D symptom severity index questionnaire

3

Description
Defecation frequency/urgency
Timepoint
Before the treatment, at the end of treatment, 4 and 8 weeks after completing treatment
Method of measurement
IBS-D symptom severity index questionnaire

Secondary outcomes

1

Description
Quality of life
Timepoint
Before and after the treatment course
Method of measurement
IBS-D quality of life questionnaire.

2

Description
Stool consistency
Timepoint
Before the treatment, at the end of treatment, 4 and 8 weeks after completing treatment
Method of measurement
bristol stool form scale

3

Description
Safety
Timepoint
At the end of treatment, 4 and 8 weeks after completing treatment
Method of measurement
recorded by physicians and patients using data gathering sheets

4

Description
Tolerability
Timepoint
At the end of treatment, 4 and 8 weeks after completing treatment
Method of measurement
Recorded by physicians and patients using data gathering sheets

Intervention groups

1

Description
Control group: 550mg capsule of rifaximin three times a day for 10 days
Category
Treatment - Drugs

2

Description
Intervention group: 550mg capsule of rifaximin four times a day for 10 days
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
Rasoul Akram Hospital; Sattarkhan Street; Niayesh 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 Sciences; Hemmat Blvd
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
Sattarkhan Street; Niayesh 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
Full name of responsible person
Marjan Mokhtare
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Adult Gastroenterology and Hepatology
Street address
Sattarkhan Street; Niayesh Street
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6652 2845
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
Sattarkhan Street; 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
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
N/A
When the data will become available and for how long
N/A
To whom data/document is available
N/A
Under which criteria data/document could be used
N/A
From where data/document is obtainable
N/A
What processes are involved for a request to access data/document
N/A
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