A Study Evaluating the Use of Implementing a Low FODMAP Diet in Irritable Bowel Syndrome Patients
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 18-011391
NCT ID: NCT03948854
Sponsor Protocol Number: 18-011391
About this study
The purpose of this study is to evaluate symptom response to a low FODMAP diet provided by different educational programs, assess adherence to the low FODMAP diet provided by different educational programs, and to measure knowledge retention for different low FODMAP educational programs.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Adult patients, age 18-75 years old.
- Seen in the primary care clinic or in the Gastroenterology clinic at Mayo Clinic Florida.
- Diagnosed with Irritable Bowel Syndrome (IBS) by Rome IV criteria.
Exclusion Criteria:
- Patients 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.
- Pregnant.
- Breast-feeding.
- Medical or psychological issues that would prevent modifying their diet for 8 weeks.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
Mayo Clinic Location |
Status |
|
Jacksonville, Fla.
Mayo Clinic principal investigator Brian Lacy, M.D., Ph.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available