Endpoint Determination Study Protocol

Endpoint Determination Study for An Antibody Guided Dietary Restriction Trial Using Biomerica InFoods® IBS Test in Patients With a Previous Diagnosis of Irritable Bowel Syndrome (IBS)

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

Study Overview

• Status: Completed
• Conditions: Irritable Bowel Syndrome
• Intervention / Treatment: Other: Food Elimination Diet

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.

• Study Type: Interventional
• Enrollment (Actual): 556
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Mayo Clinic
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic
  • Illinois
    • Wauconda, Illinois, United States, 60084
      • Family Medicine Specialists
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48109-5362
      • University of Michigan Health System
  • Texas
    • Houston, Texas, United States, 77030
      • Houston Methodist Research Institute
    • Houston, Texas, United States, 77030
      • UT Health
    • San Antonio, Texas, United States, 78229
      • Gastroenterology Research of San Antonio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the IBS-API - Abdominal Pain Intensity. The IBS-API is being assessed daily from enrollment (baseline) to study completion; total 10 weeks	Abdominal pain intensity will be measured daily using an 11-point (0-10) numeric rating scale (NRS) that asks subjects to rate their worst abdominal pain over the past 24-hours.	Daily for 10 weeks

Collaborators and Investigators

• Sponsor: Biomerica
• Investigators: Principal Investigator: William D Chey, MD, University of Michigan; Principal Investigator: Anthony J Lembo, MD, Beth Israel Deaconess Medical Center (Harvard)

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2018
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: February 20, 2018
• First Submitted That Met QC Criteria: March 7, 2018
• First Posted (Actual): March 9, 2018

Study Record Updates

• Last Update Posted (Actual): August 5, 2024
• Last Update Submitted That Met QC Criteria: August 2, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome
• Other Study ID Numbers: EPT-InF24-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: It is not yet known if there will be a plan to make IPD available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No