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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antibiotics | Active Comparator |
| |
| Dietary based therapy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rifaximin | Drug | Administration route: PO Rifaximin 400mg TDS for 2 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kee-Huat Chuah, MBBS | Contact | +60379492965 | chuah319@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Kee-Huat Chuah, MBBS | University of Malaya | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Malaya Medical Centre | Recruiting | Kuala Lumpur | Malaysia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41098003 | Derived | 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. |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D000078262 | Rifaximin |
| D000092622 | FODMAP Diet |
| ID | Term |
|---|---|
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Low FODMAP diet |
| Other |
Low FODMAP diet under dietitian guidance for 4 weeks |
|
| 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 | 4 weeks |
| Proportion of patients with SIBO who had eradication of SIBO after treatment | as measured by glucose hydrogen breath test | 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 | 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). | 4 weeks |
| D004066 | Digestive System Diseases |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D000092724 | Elimination Diets |
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |