Blood and Stool Molecular Biomarkers Longitudinal Detection Study in Crohn's Disease (CD) Patients

NCT03566407 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2019-06-07

No results posted yet for this study

Summary

To evaluate the relationship between noninvasive biomarkers (patient serological markers and metagenomic analysis of stool) and disease status as determined by colonoscopy and by clinical symptoms in patients with Crohn's disease, and to evaluate whether changes in the biomarker levels over time correlate to changes in the state of patients' disease.

Conditions

Interventions

PROCEDURE

Colonoscopy

Colonoscopy will be required for all subjects at 6 months - Visit 3.

Sponsors & Collaborators

  • Prometheus Laboratories

    lead INDUSTRY

Principal Investigators

  • Clinical Development and Medical Affairs · Prometheus Laboratories

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-04
Primary Completion
2019-03-29
Completion
2019-03-29

Countries

  • United States

Study Locations

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Entities

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 NCT03566407 on ClinicalTrials.gov