Endpoint Determination Study Protocol
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: 20-000051
NCT ID: NCT03459482
Sponsor Protocol Number: EPT-InF24-001
About this study
The purpose of this study is to evaluate the most applicable endpoints for evaluation of the Biomerica InFoods® IBS product.
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:
- 21 years old or older.
- Able to read and understand English.
- Have access to a computer and/or cell phone access for Electronic Data Capture (EDC).
- Meets Rome III or Rome IV Diagnostic Criteria for IBS -Respond "No" to IBS Adequate Relief (IBS-AR) in the past week at the screening Visit #1.
- Score between ≥ 3 and <7.5 on the Abdominal Pain Intensity Assessment (IBS_API) based on a weekly average of worst daily (in past 24 hours) abdominal pain on a 0 to 10 point scale.
- A positive IgG antibody response for at least one food in the Biomerica InFoods® IBS panel.
- Patients who are on stable (> 3 months) doses of medications or treatments for their IBS (e.g., probiotics, fiber, Viberzi, Linzess, Amitiza, Alosetron, Plecanatide, anticholinergics, antidepressants, Zofran bile acid sequestrants, or anti-diarrheals) will be allowed to continue their medications as long as no change in treatment is planned for the duration of the study and no dose adjustment is made during the duration of the study.
- Willing to follow a food elimination diet.
Exclusion Criteria:
- Cannot use EDC system due to no cell phone and no computer access.
- Unable to provide consent.
- Pregnant or breastfeeding.
- Does not qualify for a diagnosis of IBS by Rome III or IV Diagnostic Criteria.
- Diagnosed IBS, but an IBS-API score of < 3.0 and > 7.5.
- Patients who have used Rifaximin in the past 3 months.
- Patients engaged in another type of diet therapy; i.e., FODMAP.
- Patients which physicians are anticipating starting a new medication, change in dosage, diet or other treatment for IBS during the study.
- Chronic pain from other conditions besides IBS.
- Current or previous use of narcotic medications within past 3 months.
- History of prior GI surgery except for cholecystectomy or appendectomy.
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