Endpoint Determination Study Protocol

Irritable Bowel Syndrome Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03459482
• Other study ID #: EPT-InF24-001
• Status: Completed
• Phase: N/A
• Start date: June 21, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2022
• Source: Biomerica
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 556
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
United States	University of Michigan Health System	Ann Arbor	Michigan
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Houston Methodist Research Institute	Houston	Texas
United States	UT Health	Houston	Texas
United States	Mayo Clinic	Jacksonville	Florida
United States	Gastroenterology Research of San Antonio	San Antonio	Texas
United States	Mayo Clinic	Scottsdale	Arizona
United States	Family Medicine Specialists	Wauconda	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Biomerica

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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