Endpoint Determination Study Protocol
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Irritable Bowel Syndrome
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Parallel DesignMasking: Triple (Participant, Care Provider, Investigator)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 21 years and 125 years
- Gender
- Both males and females
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 i...
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.
Tracking Information
- NCT #
- NCT03459482
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: William D Chey, MD University of Michigan Principal Investigator: Anthony J Lembo, MD Beth Israel Deaconess Medical Center (Harvard)