Endpoint Determination Study Protocol
Endpoint Determination Study Protocol
This study is designed to evaluate the most applicable endpoints for evaluation of the
 Biomerica InFoods® IBS product.
The objective of this Endpoint Determination Study is to address key elements regarding a
 proposed larger clinical study design:

 1. Comparing different potential primary outcome measures

 2. Demonstrating that an exclusionary diet as determined by elevated IgG levels using the
 Biomerica InFoods® IBS Test is associated with alleviation of IBS symptoms

 3. Demonstrating the ability to mask the sham diet

 4. Demonstrating the safety of the exclusionary diet

 Subjects' diets will be based on the results of the Biomerica, InFoods® IBS Test.

 Immunoglobulin G (IgG) levels above a certain threshold are considered a positive response
 against a specific food or foods. It is expected that severity of symptoms of IBS will
 decrease when foods that generate a positive immune response in the Biomerica InFoods® IBS
 test are eliminated from the diet of the IBS patient.

 The Endpoint Determination Study format will be a double-blinded randomized controlled
 clinical study enrolling subjects at two trial sites within the United States and designed to
 evaluate the use of IgG antibody guided dietary restrictions, based on the Biomerica InFoods®
 IBS Test, in the management of patients diagnosed with Irritable Bowel Syndrome (IBS).

 The 2 sites will enroll approximately equal numbers of subjects. The target for each site is
 a minimum of 30 subjects in each classification: IBS with diarrhea [IBS-D], IBS with
 constipation [IBS-C] and IBS mixed [IBS-M] for a minimum of 90 patients per site, 180 total
 subjects for this study.
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.