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Endpoint Determination Study Protocol

NCT03459482 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 556

Last updated 2024-08-05

No results posted yet for this study

Summary

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

Conditions

  • Irritable Bowel Syndrome

Interventions

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

Sponsors & Collaborators

  • Biomerica

    lead INDUSTRY

Principal Investigators

  • William D Chey, MD · University of Michigan

  • Anthony J Lembo, MD · Beth Israel Deaconess Medical Center (Harvard)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-21
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03459482 on ClinicalTrials.gov