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Purpose

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

Condition

Eligibility

Eligible Ages
Over 21 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Parallel Design
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Group 1 - True Food Elimination Diet 		Group 1 (experimental group): Subjects will be given an elimination diet based upon foods with a positive antibody profile in the Biomerica InFoods® IBS test. The elimination diet will also exclude any and all foods to which the subject has a known IgE allergy and foods the subject already currently eliminates.
  • Other: Food Elimination Diet
    Subjects asked to participate in a food elimination diet, either True or Sham to evaluate the effects on their IBS symptoms
Sham Comparator
Group 2 - Sham Food Elimination Diet 		Group 2 (control group): Subjects will be given a "Sham" elimination diet. The sham diet will eliminate the same number of foods but none of the actual foods to which the patient had a positive antibody profile in the Biomerica InFoods® IBS test. The sham diet will also eliminate any and all foods to which the subject has a known IgE allergy and foods the subject already currently eliminates.
  • Other: Food Elimination Diet
    Subjects asked to participate in a food elimination diet, either True or Sham to evaluate the effects on their IBS symptoms

More Details

Status
Completed
Sponsor
Biomerica

Study Contact

Detailed Description

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.