Rifaximin Therapy vs Low FODMAP Diet In IBS

NCT04841980 | Unknown Phase 4

• 1 other identifier: 2021001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome; Small Intestinal Bacterial Overgrowth

Keywords

Rifaximin; low FODMAP diet; IBS; SIBO

Outcome Measures

Primary Outcomes (1)

• 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

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

  4 weeks

• Symptom severity score improvement

  4 weeks

• Proportion of patients with SIBO who had eradication of SIBO after treatment

  6 weeks

• Assessment of factors that were associated with treatment response

  6 weeks

• Change in Health-Related Quality of Life (HRQOL) score

  4 weeks

Study Arms (2)

Antibiotics

ACTIVE COMPARATOR

Drug: Rifaximin

Dietary based therapy

ACTIVE COMPARATOR

Other: Low FODMAP diet

Interventions

Rifaximin DRUG

Administration route: PO Rifaximin 400mg TDS for 2 weeks

Antibiotics

Low FODMAP diet OTHER

Low FODMAP diet under dietitian guidance for 4 weeks

Dietary based therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

University Malaya Medical Centre

Kuala Lumpur, Malaysia

RECRUITING

Related Publications (1)

• 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.

  PMID: 41098003 DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Rifaximin; FODMAP Diet

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds; Elimination Diets; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Kee-Huat Chuah, MBBS

  University of Malaya

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kee-Huat Chuah, MBBS

CONTACT

+60379492965; chuah319@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Lecturer and Clinical Specialist

Study Record Dates

• First Submitted: January 21, 2021
• First Posted: April 12, 2021
• Study Start: April 22, 2021
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: May 16, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)