Irritable Bowel SyndromePhase 4NCT04841980
Rifaximin Therapy vs Low FODMAP Diet In IBS
A Phase 4 study testing Rifaximin and Low FODMAP diet in people with Irritable Bowel Syndrome and Small Intestinal Bacterial Overgrowth, run by University of Malaya at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Irritable Bowel Syndrome, Small Intestinal Bacterial Overgrowth
- What is being tested?
- Rifaximin and Low FODMAP diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteMalaysia
- Study dates
- 22 Apr 2021to 31 May 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
University Malaya Medical Centre
Kuala Lumpur
Kee Huat Chuah, MBBS
About this study
Official title: Rifaximin Therapy Versus Low FODMAP Diet In Irritable Bowel Syndrome: A Randomised Controlled Trial
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.
- Being tested
- Rifaximin, Low FODMAP diet
- Keywords
- Rifaximin, low FODMAP diet, IBS, SIBO
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RifaximinDrug
Administration route: PO Rifaximin 400mg TDS for 2 weeks
Low FODMAP dietOther
Low FODMAP diet under dietitian guidance for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Antibiotics | Active comparator | Not described Receives: Drug: Rifaximin |
| Dietary based therapy | Active comparator | Not described Receives: Other: Low FODMAP diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (5)
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).
Measured: 4 weeks
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
Measured: 4 weeks
Proportion of patients with SIBO who had eradication of SIBO after treatment
as measured by glucose hydrogen breath test
Measured: 6 weeks
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
Measured: 6 weeks
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).
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2021
- Study start22 Apr 2021
- Primary completion31 May 2024 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Chuah Kee Huat, University of Malaya
- Investigators
- Kee-Huat Chuah, MBBS, Principal investigator, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04841980
- Sponsor's protocol ID
- 2021001
- Status last verified
- May 2023
- First submitted
- 21 Jan 2021
- Last updated
- 16 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chuah KH, Loo QY, Loh AJC, Leong JY, Chan WL, Khoo XH, Wong KL, Panirsheeluam S, Natarajan V, Ng AK, Abdul Majid H, Mahadeva S. Clinical Trial: Rifaximin Versus Low FODMAP Diet in Irritable Bowel Syndrome. Aliment Pharmacol Ther. 2026 Jan;63(2):210-221. doi: 10.1111/apt.70420. Epub 2025 Oct 16.
PubMed 41098003
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rifaximin Therapy Versus Low FODMAP Diet In Irritable Bowel Syndrome: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04841980
- Acronym / sponsor ID
- 2021001
- Keywords
- Rifaximin, low FODMAP diet, IBS, SIBO
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 22 Apr 2021 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 12 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antibiotics | Active comparator | Drug: Rifaximin |
| Dietary based therapy | Active comparator | Other: Low FODMAP diet |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RifaximinAdministration route: PO Rifaximin 400mg TDS for 2 weeks | Drug | Antibiotics |
| Low FODMAP dietLow FODMAP diet under dietitian guidance for 4 weeks | Other | Dietary based therapy |
Primary outcome
Proportion of subjects with adequate relief of composite of abdominal symptom (pain/discomfort) and stool symptom (frequency/ consistency) after treatment.
Time frame: 4 weeks
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.
5 secondary outcomes
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
Time frame: 4 weeks
Symptom severity score improvement
Time frame: 4 weeks
Proportion of patients with SIBO who had eradication of SIBO after treatment
Time frame: 6 weeks
Assessment of factors that were associated with treatment response
Time frame: 6 weeks
Change in Health-Related Quality of Life (HRQOL) score
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
- Derived from this study: PubMed 41098003Chuah KH, Loo QY, Loh AJC, Leong JY, Chan WL, Khoo XH, Wong KL, Panirsheeluam S, Natarajan V, Ng AK, Abdul Majid H, Mahadeva S. Clinical Trial: Rifaximin Versus Low FODMAP Diet in Irritable Bowel Syndrome. Aliment Pharmacol Ther. 2026 Jan;63(2):210-221. doi: 10.1111/apt.70420. Epub 2025 Oct 16.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kee-Huat Chuah, MBBS principal investigator
University of Malaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rifaximin and Low FODMAP diet in people with Irritable Bowel Syndrome and Small Intestinal Bacterial Overgrowth, run by University of Malaya at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kee-Huat Chuah, MBBS (+60379492965, chuah319@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects with adequate relief of composite of abdominal symptom (pain/discomfort) and stool symptom (frequency/ consistency) after treatment. (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04841980, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2023.