OptiCal Study -Optimizing Fecal Calprotectin Monitoring: a Clinical Study Comparing CalproLab Against PhiCal and Evaluating Its Association With the Gut Microbiome

NCT03051204 | Completed

• 1 other identifier: IRB#16-001499
• Study Type: observational
• Target: 175
• Locations: 1 country
• Sites: 1

Brief Summary

Study Aims: To analyze stool specimens to test and validate the CalproLab assay against the predicate PhiCal in order to determine performance characteristics. And to correlate Calpro levels to the gut microbiome composition.

Conditions

Crohn Disease; Ulcerative Colitis; Irritable Bowel Syndrome; Celiac Disease; Healthy

Outcome Measures

Primary Outcomes (1)

• Calprotectin

  Concentration of calprotectin in stool sample

  up to 2 weeks from consent/enrollment

Eligibility Criteria

• Age: 4 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male and female subjects 4-65y years of age with diagnosed Crohn's disease and ulcerative colitis. (75) IBD patients - Ulcerative Colitis (UC) or Crohn's Disease (CD) (50) IBS patients (25) Celiac Disease Patients (25) Healthy Controls

You may qualify if:

• Male and female IBD patients should have had CD or UC for at least a period of six months\*
• Male and female patients should have had Celiac disease for at least three months.
• Subjects willing and able to sign informed consent
• Subjects willing and able to provide stool sample using a home kit
• IBS patients will meet Rome Foundation criteria and received standard of care evaluations to exclude other diagnoses

You may not qualify if:

• Unwilling or unable to adhere to the protocol
• Unwilling or unable to adhere to the informed consent
• Age \<4y or \>65y
• Any of the following conditions by medical history:
• Individuals with intestinal cancer
• Individual taking anti-inflammatory drugs
• Individuals receiving chemotherapy
• Individuals with a known intestinal infection
• Individuals with known upper gastrointestinal disease such as esophagitis or gastritis that might influence the test's ability to detect intestinal inflammatory disease.
• Individuals who are scheduled for endoscopy within 24 hours after providing the sample, or have undergone endoscopy during the 72 hours before providing the sample.

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Genova Diagnostics: collaborator

Study Sites (1)

UCLA Center for Inflammatory Bowel Diseases

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative; Irritable Bowel Syndrome; Celiac Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases; Colonic Diseases, Functional; Malabsorption Syndromes; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Daniel Hommes, MD

  UCLA IBD CENTER

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2017
• First Posted: February 13, 2017
• Study Start: February 28, 2017
• Primary Completion: December 11, 2018
• Study Completion: December 11, 2018
• Last Updated: September 22, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)