ALPCO Calprotectin ELISA - Measurement of Calprotectin Levels in Human Stool

Inflammatory Bowel Diseases Clinical Trial

Official title:

ALPCO Calprotectin ELISA - Measurement of Calprotectin Levels in Human Stool

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03082287
• Other study ID #: ALPCOCAL
• Status: Completed
• Start date: May 1, 2017
• Est. completion date: October 25, 2019

Study information

• Verified date: November 2019
• Source: American Laboratory Products Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 424
• Est. completion date: October 25, 2019
• Est. primary completion date: October 25, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Irritable Bowel Syndrome

Intervention

Device:
• Fecal Calprotectin Level
Measurement of calprotectin in feces

Locations

Country	Name	City	State
United States	ALPCO	Salem	New Hampshire

Sponsors (2)

Lead Sponsor	Collaborator
American Laboratory Products Company	MDC Associates, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In vitro diagnostic value of Calprotectin	Value of calprotectin measurement in the ELISA	Through study completion, up to 52 weeks.