Rifaximin Therapy vs Low FODMAP Diet In IBS
Primary Purpose
Irritable Bowel Syndrome, Small Intestinal Bacterial Overgrowth
Status
Recruiting
Phase
Phase 4
Locations
Malaysia
Study Type
Interventional
Intervention
Rifaximin
Low FODMAP diet
Sponsored by
About this trial
This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Rifaximin, low FODMAP diet, IBS, SIBO
Eligibility Criteria
Inclusion Criteria:
- Patients diagnosed with Irritable bowel syndrome using Rome III diagnostic criteria with Abdominal Pain/ Discomfort Intensity of weekly average of worst abdominal pain/ discomfort in past 24 hours score of ≥ 3.0 on a 0 to 10 point scale AND Stool Consistency of at least 2 days per week with at least one stool that has a consistency of Type 6 or Type 7 BSS or <3 CSBM per week
- Subject who can provide written informed consent and willingness to comply with the requirement of the protocol
- Able to communicate in English, Malay, or Mandarin languages
Exclusion Criteria:
- Patients with known hypersensitivity or contraindication to Rifaximin
- Pregnant / breastfeeding women
- Patients who are on probiotics for the past 1 month
- Presence of family history of GI malignancy or alarm features suggested malignancy - e.g. Unintentional weight loss (≥ 10% of body weight in recent 6 months), GI bleeding
- History of gastrointestinal (GI) malignancy
- Patients with any hepatobiliary or pancreatic diseases
- Patients with severe depression, anxiety, or other psychological disorder
- Patients with any terminal disease
- Other conditions determined by the investigator to be inappropriate for this clinical study
Sites / Locations
- University Malaya Medical CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Antibiotics
Dietary based therapy
Arm Description
Outcomes
Primary Outcome Measures
Proportion of subjects with adequate relief of composite of abdominal symptom (pain/discomfort) and stool symptom (frequency/ consistency) after treatment.
Adequate relief was defined as self-reported relief of both symptoms (abdominal symptom and stool symptom) at least in week 2 or 4. (Subjects will be provided with self-reported questionnaires for week 2 and 4).
For IBS-D, relief was defined as a decrease of at least 30% from baseline in weekly mean ratings of IBS-related abdominal pain or discomfort and a weekly decrease of at least 50% in the number of days per week with at least one stool that has a consistency of Type 6 or 7 compared with baseline.
For IBS-C, relief was defined as a decrease of at least 30% from baseline in weekly mean ratings of IBS-related abdominal pain or discomfort and an increase of 1 or more complete spontaneous bowel movement (CSBM) per week compared with baseline.
For IBS-M, relief was defined as fulfilled both IBS-D and IBS-C symptom relief criteria.
Secondary Outcome Measures
Proportion of patients who had relief was determined from the patients' weekly assessments of global IBS symptoms, bloating, abdominal pain/ discomfort, and stool consistency/ frequency after treatment with Rifaximin or low FODMAP diet
Rated on a 5-point scale: 2 = Significantly Relieved, 1 = Moderately Relieved, 0 = Unchanged, -1 = Moderately Worse, and -2 = Significantly Worse for at least 50% of the days in a week.
Relief was defined as a score of either 2 (Significantly Relieved) or 1 (Moderately Relieved).
Symptom severity score improvement
The symptom severity was assessed by the IBS-symptom severity (IBS-SS) score from baseline to 4 weeks after initiation of treatment. Total scores ranging from 0 to 500
Proportion of patients with SIBO who had eradication of SIBO after treatment
as measured by glucose hydrogen breath test
Assessment of factors that were associated with treatment response
Baseline characteristic (age, gender, ethnicity), IBS subtype (IBS-D, IBS-C IBS-mixed), and SIBO status (positive or negative) of patients who responded to treatment (based on primary outcome) will be compared to non-responder
Change in Health-Related Quality of Life (HRQOL) score
HRQOL will be assessed using EuroQol-5D (EQ-5D) instrument. Overall utility score (as mean value) was calculated with a range score from 0 (worst health scenario) to a maximum of 1.0 (best health scenario).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04841980
Brief Title
Rifaximin Therapy vs Low FODMAP Diet In IBS
Official Title
Rifaximin Therapy Versus Low FODMAP Diet In Irritable Bowel Syndrome: A Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 22, 2021 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Malaya
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Functional gastrointestinal disorders (FGIDs) are common and from the most recent global epidemiology study, an estimated 40% of the world population suffer from the condition. FGIDs cause significant morbidity to patients, despite not influencing mortality. IBS is among the most important functional gastrointestinal disorder with an estimated 3.8 to 9.2 % of the general population worldwide were affected by this disorder.
Rifaximin (gut specific antibiotic) and low FODMAP diet (dietary based therapy) were proven to be effective in treating irritable bowel syndrome (IBS), however there was no head-to-head study comparing both treatments. This study will help doctors to understand the efficacy of different IBS/SIBO treatments. With the evaluation of factors that can predict treatment response, doctor could potentially treat IBS and SIBO more effectively in future.
The purpose of the study is to compare the clinical symptoms and psychological improvement in patients with irritable bowel syndrome (IBS) after treatment with Rifaximin versus treatment with low FODMAP diet. The factors that is associated with treatment response will also be evaluated. In IBS patients with small intestinal bacterial overgrowth (SIBO), eradication rate of SIBO will be evaluated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome, Small Intestinal Bacterial Overgrowth
Keywords
Rifaximin, low FODMAP diet, IBS, SIBO
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Antibiotics
Arm Type
Active Comparator
Arm Title
Dietary based therapy
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Rifaximin
Intervention Description
Administration route: PO Rifaximin 400mg TDS for 2 weeks
Intervention Type
Other
Intervention Name(s)
Low FODMAP diet
Intervention Description
Low FODMAP diet under dietitian guidance for 4 weeks
Primary Outcome Measure Information:
Title
Proportion of subjects with adequate relief of composite of abdominal symptom (pain/discomfort) and stool symptom (frequency/ consistency) after treatment.
Description
Adequate relief was defined as self-reported relief of both symptoms (abdominal symptom and stool symptom) at least in week 2 or 4. (Subjects will be provided with self-reported questionnaires for week 2 and 4).
For IBS-D, relief was defined as a decrease of at least 30% from baseline in weekly mean ratings of IBS-related abdominal pain or discomfort and a weekly decrease of at least 50% in the number of days per week with at least one stool that has a consistency of Type 6 or 7 compared with baseline.
For IBS-C, relief was defined as a decrease of at least 30% from baseline in weekly mean ratings of IBS-related abdominal pain or discomfort and an increase of 1 or more complete spontaneous bowel movement (CSBM) per week compared with baseline.
For IBS-M, relief was defined as fulfilled both IBS-D and IBS-C symptom relief criteria.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Proportion of patients who had relief was determined from the patients' weekly assessments of global IBS symptoms, bloating, abdominal pain/ discomfort, and stool consistency/ frequency after treatment with Rifaximin or low FODMAP diet
Description
Rated on a 5-point scale: 2 = Significantly Relieved, 1 = Moderately Relieved, 0 = Unchanged, -1 = Moderately Worse, and -2 = Significantly Worse for at least 50% of the days in a week.
Relief was defined as a score of either 2 (Significantly Relieved) or 1 (Moderately Relieved).
Time Frame
4 weeks
Title
Symptom severity score improvement
Description
The symptom severity was assessed by the IBS-symptom severity (IBS-SS) score from baseline to 4 weeks after initiation of treatment. Total scores ranging from 0 to 500
Time Frame
4 weeks
Title
Proportion of patients with SIBO who had eradication of SIBO after treatment
Description
as measured by glucose hydrogen breath test
Time Frame
6 weeks
Title
Assessment of factors that were associated with treatment response
Description
Baseline characteristic (age, gender, ethnicity), IBS subtype (IBS-D, IBS-C IBS-mixed), and SIBO status (positive or negative) of patients who responded to treatment (based on primary outcome) will be compared to non-responder
Time Frame
6 weeks
Title
Change in Health-Related Quality of Life (HRQOL) score
Description
HRQOL will be assessed using EuroQol-5D (EQ-5D) instrument. Overall utility score (as mean value) was calculated with a range score from 0 (worst health scenario) to a maximum of 1.0 (best health scenario).
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients diagnosed with Irritable bowel syndrome using Rome III diagnostic criteria with Abdominal Pain/ Discomfort Intensity of weekly average of worst abdominal pain/ discomfort in past 24 hours score of ≥ 3.0 on a 0 to 10 point scale AND Stool Consistency of at least 2 days per week with at least one stool that has a consistency of Type 6 or Type 7 BSS or <3 CSBM per week
Subject who can provide written informed consent and willingness to comply with the requirement of the protocol
Able to communicate in English, Malay, or Mandarin languages
Exclusion Criteria:
Patients with known hypersensitivity or contraindication to Rifaximin
Pregnant / breastfeeding women
Patients who are on probiotics for the past 1 month
Presence of family history of GI malignancy or alarm features suggested malignancy - e.g. Unintentional weight loss (≥ 10% of body weight in recent 6 months), GI bleeding
History of gastrointestinal (GI) malignancy
Patients with any hepatobiliary or pancreatic diseases
Patients with severe depression, anxiety, or other psychological disorder
Patients with any terminal disease
Other conditions determined by the investigator to be inappropriate for this clinical study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kee-Huat Chuah, MBBS
Phone
+60379492965
Email
chuah319@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kee-Huat Chuah, MBBS
Organizational Affiliation
University Malaya
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Malaya Medical Centre
City
Kuala Lumpur
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kee Huat Chuah, MBBS
12. IPD Sharing Statement
Plan to Share IPD
No
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Rifaximin Therapy vs Low FODMAP Diet In IBS
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