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

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ClinicalTrials.gov Identifier: NCT03051204
Recruitment Status : Recruiting
First Posted : February 13, 2017
Last Update Posted : October 26, 2017
Sponsor:
Collaborator:
Genova Diagnostics
Information provided by (Responsible Party):
Daniel Hommes, MD, University of California, Los Angeles

Tracking Information
First Submitted Date February 9, 2017
First Posted Date February 13, 2017
Last Update Posted Date October 26, 2017
Actual Study Start Date February 28, 2017
Estimated Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 10, 2017)
Calprotectin [ Time Frame: up to 2 weeks from consent/enrollment ]
Concentration of calprotectin in stool sample
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03051204 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title OptiCal Study -Optimizing Fecal Calprotectin Monitoring: a Clinical Study Comparing CalproLab Against PhiCal and Evaluating Its Association With the Gut Microbiome
Official Title OptiCal Study -Optimizing Fecal Calprotectin Monitoring: a Clinical Study Comparing CalproLab Against PhiCal and Evaluating Its Association With the Gut Microbiome
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.

Detailed Description

Fecal Calprotectin has become one of the most frequently used biomarkers in patients suffering from Inflammatory Bowel Diseases. Although its use for monitoring disease activity and therapeutic efficiency has previously been demonstrated, the test performance should further be optimized to improve clinical accuracy. The PhiCal™ test is a quantitative ELISA for measuring, in human stool, concentrations of fecal calprotectin, a neutrophilic protein that is a marker of mucosal inflammation. The PhiCal™ test can be used as an in vitro diagnostic to aid in the diagnosis of inflammatory bowel diseases (Crohn's disease and Ulcerative Colitis), and to differentiate IBD from irritable bowel syndrome. Recently, the CalproLab™ in vitro device has become available which provides a greater reporting range than PhiCal™. The OptiCal study aims to test and validate the CalproLab™ assay against the PhiCal™ assay and determine its performance characteristics.

Calprotectin is a valuable clinical marker for inflammation. Calprotectin belongs to a group of calcium- binding neutrophil-derived proteins. Calprotectin makes up 60% of the cytosolic proteins within the neutrophil. It is very resistant to bacterial degradation in the gut and is stable in stool for up to one week

at room temperature. Calprotectin is the noninvasive "test of choice" for quantifying the degree of GI inflammation and differentiating Irritable Bowel Syndrome (IBS) from Inflammatory Bowel Disease (IBD).

Inflammatory bowel disease (IBD) is considered to result from interplay between host and intestinal microbiota. Recently it was shown that the microbiota varied along a gradient of increasing intestinal inflammation (indicated by calprotectin levels), which was associated with reduced microbial richness, abundance of butyrate producers, and relative abundance of Gram-positive bacteria (especially Clostridium clusters IV and XIVa). A significant association between microbiota composition and inflammation was indicated by a set of bacterial groups predicting the calprotectin levels. So, intestinal microbiota may represent a potential biomarker for correlating the level of inflammation and therapeutic responses but this needs to be further validated.

  • This study is a prospective case series during which patients with either Crohn's disease or ulcerative colitis, Celiac Disease, Irritable Bowel Syndrome and healthy controls (N=175) will be invited to participate.
  • Participants will receive a home kit (with a plain white plastic cup for calprotectin sample collections) for stool sampling, which then will be returned and processed at Genova Diagnostics. All participants are required to complete a patient survey, which will be included in the collection kit.
  • Participants will be recruited through the UCLA Division of Digestive Diseases.
  • All patients will have confirmation of their diagnosis according to published clinical guidelines and standards of care using gold standard diagnostics (e.g. endoscopy)
  • Stool specimens will be analyzed for fecal Calprotectin using both the CalproLab™ assay and the PhiCal™ assay. No blood draws or other testing will be performed.
  • Patients will undergo a gut microbiome assessment utilizing the GI Effects™ 2200 Comprehensive Profile (Genova Diagnostics).
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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

Condition
  • Crohn Disease
  • Ulcerative Colitis
  • Irritable Bowel Syndrome
  • Celiac Disease
  • Healthy
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 10, 2017)
175
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 2020
Estimated Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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
  • Healthy controls will consist of patients who do not have any IBD or IBS diagnosis and meet exclusion criteria for health in nearby table

Exclusion Criteria:

  • 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 4 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Daniel Hommes, MD 310-206-3778 dhommes@mednet.ucla.edu
Contact: Miriam Dvorsky 310-206-3778 mdvorksy@mednet.ucla.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03051204
Other Study ID Numbers IRB#16-001499
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: All participants data will be de-identified by the research coordinator in standing with HIPAA regulations.
Responsible Party Daniel Hommes, MD, University of California, Los Angeles
Study Sponsor University of California, Los Angeles
Collaborators Genova Diagnostics
Investigators
Principal Investigator: Daniel Hommes, MD UCLA IBD CENTER
PRS Account University of California, Los Angeles
Verification Date October 2017