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Endpoint Determination Study Protocol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03459482
Recruitment Status : Completed
First Posted : March 9, 2018
Last Update Posted : March 18, 2022
Sponsor:
Information provided by (Responsible Party):
Biomerica

Tracking Information
First Submitted Date  ICMJE February 20, 2018
First Posted Date  ICMJE March 9, 2018
Last Update Posted Date March 18, 2022
Actual Study Start Date  ICMJE June 21, 2018
Actual Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 7, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Endpoint Determination Study Protocol
Official Title  ICMJE 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)
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:

  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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Parallel Design
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Irritable Bowel Syndrome
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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.
    Intervention: Other: Food Elimination Diet
  • 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.
    Intervention: Other: Food Elimination Diet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 14, 2022)
556
Original Estimated Enrollment  ICMJE
 (submitted: March 7, 2018)
180
Actual Study Completion Date  ICMJE December 31, 2021
Actual Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03459482
Other Study ID Numbers  ICMJE EPT-InF24-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: It is not yet known if there will be a plan to make IPD available.
Responsible Party Biomerica
Study Sponsor  ICMJE Biomerica
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: William D Chey, MD University of Michigan
Principal Investigator: Anthony J Lembo, MD Beth Israel Deaconess Medical Center (Harvard)
PRS Account Biomerica
Verification Date March 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP