Rifaximin Therapy vs Low FODMAP Diet In IBS

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-22

Study Completion Date

2024-05-31

Brief Summary

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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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Detailed Description

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Conditions

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Irritable Bowel Syndrome Small Intestinal Bacterial Overgrowth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Antibiotics

Group Type ACTIVE_COMPARATOR

Rifaximin

Intervention Type DRUG

Administration route: PO Rifaximin 400mg TDS for 2 weeks

Dietary based therapy

Group Type ACTIVE_COMPARATOR

Low FODMAP diet

Intervention Type OTHER

Low FODMAP diet under dietitian guidance for 4 weeks

Interventions

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Rifaximin

Administration route: PO Rifaximin 400mg TDS for 2 weeks

Intervention Type DRUG

Low FODMAP diet

Low FODMAP diet under dietitian guidance for 4 weeks

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. 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
2. Subject who can provide written informed consent and willingness to comply with the requirement of the protocol
3. Able to communicate in English, Malay, or Mandarin languages

Exclusion Criteria

1. Patients with known hypersensitivity or contraindication to Rifaximin
2. Pregnant / breastfeeding women
3. Patients who are on probiotics for the past 1 month
4. 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
5. History of gastrointestinal (GI) malignancy
6. Patients with any hepatobiliary or pancreatic diseases
7. Patients with severe depression, anxiety, or other psychological disorder
8. Patients with any terminal disease
9. Other conditions determined by the investigator to be inappropriate for this clinical study

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No