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Endpoint Determination Study Protocol

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ClinicalTrials.gov Identifier: NCT03459482
Recruitment Status : Recruiting
First Posted : March 9, 2018
Last Update Posted : June 26, 2018
Sponsor:
Information provided by (Responsible Party):
Biomerica

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

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Other: Food Elimination Diet Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Design
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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)
Actual Study Start Date : June 21, 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : March 2019

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




Primary Outcome Measures :
  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 [ Time Frame: Daily for 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.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03459482


Contacts
Contact: Carolyn Shoup 949-645-2111 ext 876 cshoup@biomerica.com
Contact: Elisabeth Laderman, PhD 949-645-2111 ext 879 eladerman@biomerica.com

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Vivian Cheng, MS, MPH    617-667-0682    vcheng2@bidmc.harvard.edu   
Principal Investigator: Anthony J Lembo, MD         
United States, Michigan
University of Michigan Health System Recruiting
Ann Arbor, Michigan, United States, 48109-5362
Contact: Lina Nahlawi, MPH    734-936-2761    lnahlawi@med.umich.edu   
Principal Investigator: William D Chey, MD         
Sponsors and Collaborators
Biomerica
Investigators
Principal Investigator: William D Chey, MD University of Michigan
Principal Investigator: Anthony J Lembo, MD Beth Israel Deaconess Medical Center (Harvard)

Responsible Party: Biomerica
ClinicalTrials.gov Identifier: NCT03459482     History of Changes
Other Study ID Numbers: EPT-InF24-001
First Posted: March 9, 2018    Key Record Dates
Last Update Posted: June 26, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: It is not yet known if there will be a plan to make IPD available.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Colonic Diseases, Functional
Syndrome
Irritable Bowel Syndrome
Disease
Pathologic Processes
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Antibodies
Immunologic Factors
Physiological Effects of Drugs