Rifaximin Therapy vs Low FODMAP Diet In IBS (NCT04841980) | Clinical Trial Compass
UnknownPhase 4
Rifaximin Therapy vs Low FODMAP Diet In IBS
Malaysia100 participantsStarted 2021-04-22
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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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
What they're measuring
1
Proportion of subjects with adequate relief of composite of abdominal symptom (pain/discomfort) and stool symptom (frequency/ consistency) after treatment.