OptiCal Study -Optimizing Fecal Calprotectin Monitoring: a Clinical Study Comparing CalproLab Against PhiCal and Evaluating Its Association With the Gut Microbiome
Condition: Crohn Disease; Ulcerative Colitis; Irritable Bowel Syndrome; Celiac Disease; Healthy
MeSH terms: Crohn Disease; Irritable Bowel Syndrome; Celiac Disease
Study type: Observational

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).
    

Observational model: Case-Only
Time perspective: Prospective
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