ALPCO Calprotectin ELISA - Measurement of Calprotectin Levels in Human Stool

Study Purpose

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.

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
Yes

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.

Study Type
Observational
Eligible Ages 22 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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.
Patients may be advised of the study and if report taking NSAIDS may be enrolled in the study after the patient has stopped use of NSAIDS for a minimum of 2 weeks.
  • - 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.
Fifty (50) presenting for routine colonoscopy and 50 patients presenting with no disease symptoms and not scheduled for a colonoscopy.
  • - 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.

Trial Details

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.

Trial ID:
NCT03082287

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.

Phase

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
American Laboratory Products Company

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
Fran White
Principal Investigator Affiliation MDC Associates

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
IndustryOther
Overall Status Recruiting
Countries United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Inflammatory Bowel Diseases, Irritable Bowel Syndrome

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

ALPCO, Salem, New Hampshire

Status

Recruiting

Address

ALPCO

Salem, New Hampshire, 03079

Site Contact

Bethany Bell

bbell@alpco.com

1-800-592-5726

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