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ALPCO Calprotectin ELISA - Measurement of Calprotectin Levels in Human Stool

ALPCO Calprotectin ELISA - Measurement of Calprotectin Levels in Human Stool

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03082287
Enrollment
424
Registered
2017-03-17
Start date
2017-05-01
Completion date
2019-10-25
Last updated
2019-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Bowel Diseases, Irritable Bowel Syndrome

Brief summary

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.

Interventions

Measurement of calprotectin in feces

Sponsors

MDC Associates, LLC
CollaboratorUNKNOWN
American Laboratory Products Company
Lead SponsorINDUSTRY

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
In vitro diagnostic value of CalprotectinThrough study completion, up to 52 weeks.Value of calprotectin measurement in the ELISA

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026