NCT03459482

Endpoint Determination Study Protocol

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 556 (actual)
• Sponsor: Biomerica · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Irritable Bowel Syndrome

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-06-21
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2018-03-09
• Last updated: 2024-08-05

Locations

8 sites across 1 country: United States