Endpoint Determination Study Protocol

Completed · Not applicable · Has a placebo group

Conditions studied: Irritable Bowel Syndrome

In brief

This study is designed to evaluate the most applicable endpoints for evaluation of the Biomerica InFoods® IBS product.

Key facts

Study ID

NCT03459482

Run by

Biomerica

People needed

556

Starts

2018-06-21

Expected to finish

2021-12-31

Last updated by the study team

2024-08-05

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 21 years old or older.
• Able to read and understand English.
• Willing and able to sign the informed consent.
• Have access to a computer and/or cell phone access for Electronic Data Capture (EDC)
• Meets Rome IV Diagnostic Criteria for IBS
• Willing to follow a food elimination die
• Well controlled diabetic patients; A1C <7.5 and stable medication (>3 months, NOT Metformin
• 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.
• 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.
• A positive IgG antibody response for at least one food in the Biomerica InFoods® IBS panel

You may not qualify if…

• Unable to provide consent.
• Cannot use EDC system due to no cell phone and no computer access
• Does not qualify for a diagnosis of IBS by IV Diagnostic Criteria
• Diagnosed IBS, but an IBS-API score of <3.0 and >7.5
• Pregnant or breastfeeding
• Patients with diabetes currently on Metformin
• 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.
• History with any of the following:
• Gastroparesis, Uncontrolled GERD, Anorexia/bulimia Celiac disease Crohn's disease, Ulcerative Colitis, Abdominal/gastro cancer(s), Malabsorption syndrome(s).
• History of any other relevant inter-current medical conditions that could interfere with their participation in the study or the objectives of the study
• History of psychosis, schizophrenia, mania, or major psychiatric illness needing hospitalization within the past 6 months

Where it is running

• Mayo Clinic — Scottsdale, Arizona, United States
• Mayo Clinic — Jacksonville, Florida, United States
• Family Medicine Specialists — Wauconda, Illinois, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• University of Michigan Health System — Ann Arbor, Michigan, United States
• Houston Methodist Research Institute — Houston, Texas, United States
• UT Health — Houston, Texas, United States
• Gastroenterology Research of San Antonio — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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