ALPCO Calprotectin ELISA - Measurement of Calprotectin Levels in Human Stool
The ALPCO Calprotectin ELISA is an in vitro diagnostic test intended to quantitatively measure concentrations of fecal calprotectin in human stool samples. Calprotectin is a protein biomarker of mucosal inflammation. Measurement of calprotectin can aid in the diagnosis of Inflammatory Bowel Diseases (IBD), specifically Crohn's Disease (CD) and Ulcerative Colitis (UC), as well as aid in the differentiation of IBD from Irritable Bowel Syndrome (IBS) when used in conjunction with other diagnostic testing and the total clinical picture. This study will estimate the predictive values of a negative (NPV) and positive (PPV) test by utilizing the assay outcomes of the ALPCO Calprotectin ELISA.
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||22 Years and Over|
Inclusion Criteria:Inclusion Criteria (IBD or IBS subjects):
- - >18 years of age - Patient must present with signs and symptoms of IBS or IBD - Patient must be scheduled for a colonoscopy - All results of the colonoscopy including histology must be provided to study site and sponsor.
- - Medical Chart review may be required to confirm diagnosis of IBS or IBD - Patient must not have taken NSAIDs for at least 2 weeks prior to participating in the study.
- - For normal patient population - study participants must present with no signs or symptoms of IBS or IBD, must not have taken NSAIDs for at least a period of 2 weeks and must be willing to provide a stool sample.
- - Sample must be collected at least 2-3 days prior to colonoscopy Inclusion Criteria (normal subjects): - Male or female, ≥18 years of age.
- - No abdominal complaints and no history of IBS, IBD, or other chronic intestinal disorder, confirmed by medical history and physical examination at enrollment.
- - May have undergone colonoscopy with negative findings within the past 1 month or may have no recent colonoscopy, but scheduled for routine screening colonoscopy.
- - Able to understand the study and the task required, and sign the ICF.
Exclusion Criteria:Exclusion Criteria (IBD or IBS Subjects):
- - patient under the age of 18 - Patient taking NSAIDs - Patients not presenting with signs or symptoms of IBS or IBD with the exception of 100 normal patients to be included in the study.
- - Patients not scheduled to have an colonoscopy unless enrolled in the study as normal population Exclusion Criteria (normal subjects): - Unable or unwilling to provide a stool specimen.
- - Have taken protein pump inhibitors (PPIs) or H2-receptor antagonists for control of upper GI disease within the previous 2 weeks.
- - Have taken NSAIDs (including aspirin) on within 2 weeks of study enrollment.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|American Laboratory Products Company|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||MDC Associates|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Inflammatory Bowel Diseases, Irritable Bowel Syndrome|
Contact a Trial Team
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