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Endpoint Determination Study Protocol

Primary Purpose

Irritable Bowel Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Food Elimination Diet
Sponsored by
Biomerica
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mayo Clinic
  • Mayo Clinic
  • Family Medicine Specialists
  • Beth Israel Deaconess Medical Center
  • University of Michigan Health System
  • Houston Methodist Research Institute
  • UT Health
  • Gastroenterology Research of San Antonio

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Group 1 - True Food Elimination Diet

Group 2 - Sham Food Elimination Diet

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 20, 2018
Last Updated
March 16, 2022
Sponsor
Biomerica
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1. Study Identification

Unique Protocol Identification Number
NCT03459482
Brief Title
Endpoint Determination Study Protocol
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
June 21, 2018 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biomerica

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is designed to evaluate the most applicable endpoints for evaluation of the Biomerica InFoods® IBS product.
Detailed Description
The objective of this Endpoint Determination Study is to address key elements regarding a proposed larger clinical study design: Comparing different potential primary outcome measures Demonstrating that an exclusionary diet as determined by elevated IgG levels using the Biomerica InFoods® IBS Test is associated with alleviation of IBS symptoms Demonstrating the ability to mask the sham diet 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Design
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
556 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 - True Food Elimination Diet
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 2 - Sham Food Elimination Diet
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Food Elimination Diet
Intervention Description
Subjects asked to participate in a food elimination diet, either True or Sham to evaluate the effects on their IBS symptoms
Primary Outcome Measure Information:
Title
Change in the IBS-API - Abdominal Pain Intensity. The IBS-API is being assessed daily from enrollment (baseline) to study completion; total 10 weeks
Description
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.
Time Frame
Daily for 10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William D Chey, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anthony J Lembo, MD
Organizational Affiliation
Beth Israel Deaconess Medical Center (Harvard)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Family Medicine Specialists
City
Wauconda
State/Province
Illinois
ZIP/Postal Code
60084
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-5362
Country
United States
Facility Name
Houston Methodist Research Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
UT Health
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Gastroenterology Research of San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
It is not yet known if there will be a plan to make IPD available.

Learn more about this trial

Endpoint Determination Study Protocol

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