Status:
UNKNOWN
Rifaximin Therapy vs Low FODMAP Diet In IBS
Lead Sponsor:
University of Malaya
Conditions:
Irritable Bowel Syndrome
Small Intestinal Bacterial Overgrowth
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04841980
Start Date
April 22 2021
End Date
May 31 2024
Last Update
May 16 2023
Active Locations (1)
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1
University Malaya Medical Centre
Kuala Lumpur, Malaysia