Endpoint Determination Study Protocol

Overview

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 Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Brian Lacy, M.D., Ph.D.

Contact us for the latest status

Contact information:

Katrina Taylor B.S.

Taylor.Katrina@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

.
CLS-20488751

Mayo Clinic Footer