IBS - Irritable Bowel Syndrome Clinical Trial
Official title:
Implementing a Low FODMAP Diet in Irritable Bowel Syndrome Patients: Which Educational Method Works Best
Verified date | December 2022 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Researchers are trying to determine the best course of action regarding the dietary management with a diet low in fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP diet) for irritable bowel syndrome.
Status | Completed |
Enrollment | 49 |
Est. completion date | February 19, 2022 |
Est. primary completion date | February 19, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Adult subjects (18-75 years) seen in the primary care clinic or in the Gastroenterology clinic at Mayo Clinic Florida, who are diagnosed with IBS by Rome IV criteria Exclusion Criteria: - Subjects who have previously tried the low FODMAP diet (whether successful or not) - Current or recent (less than 4 weeks) opioid use - Current or recent (less than 10 weeks) rifaximin use - Inability to speak or read English - Pregnancy and/or breast-feeding - Medical or psychological issues that would prevent modifying their diet for 8 weeks. |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic in Florida | Jacksonville | Florida |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Improvement in IBS symptoms | Change in IBS symptoms will be measured from baseline to the end of study using the validated IBS symptoms severity scale (IBS-SS). This is a visual analog scale from 0-100. The primary outcome measure is improvement in symptom scores from end of study to baseline. | Baseline, end of study approximately 8 to 10 weeks |
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