Endpoint Determination Study Protocol

NCT03459482 | Completed

• 1 other identifier: EPT-InF24-001
• Study Type: interventional
• Target: 556
• Locations: 1 country
• Sites: 8

Brief Summary

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

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Group 1 - True Food Elimination Diet

EXPERIMENTAL

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

Group 2 - Sham Food Elimination Diet

SHAM COMPARATOR

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

Interventions

Food Elimination Diet OTHER

Subjects asked to participate in a food elimination diet, either True or Sham to evaluate the effects on their IBS symptoms

Group 1 - True Food Elimination Diet; Group 2 - Sham Food Elimination Diet

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Biomerica: lead

Study Sites (8)

Mayo Clinic

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Family Medicine Specialists

Wauconda, Illinois, 60084, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

University of Michigan Health System

Ann Arbor, Michigan, 48109-5362, United States

Location

Houston Methodist Research Institute

Houston, Texas, 77030, United States

Location

UT Health

Houston, Texas, 77030, United States

Location

Gastroenterology Research of San Antonio

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

• Singh P, Chey WD, Takakura W, Cash BD, Lacy BE, Quigley EMM, Randall CW, Lembo A. A Novel, IBS-Specific IgG ELISA-Based Elimination Diet in Irritable Bowel Syndrome: A Randomized, Sham-Controlled Trial. Gastroenterology. 2025 Jun;168(6):1128-1136.e4. doi: 10.1053/j.gastro.2025.01.223. Epub 2025 Jan 31.

  PMID: 39894284 DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• William D Chey, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Anthony J Lembo, MD

  Beth Israel Deaconess Medical Center (Harvard)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel Design

Study Record Dates

• First Submitted: February 20, 2018
• First Posted: March 9, 2018
• Study Start: June 21, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: August 5, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)