ALPCO Calprotectin ELISA - Measurement of Calprotectin Levels in Human Stool
| Status: | Recruiting |
|---|---|
| Conditions: | Irritable Bowel Syndrome (IBS), Irritable Bowel Syndrome (IBS), Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 22 - Any |
| Updated: | 6/29/2017 |
| Start Date: | May 1, 2017 |
| End Date: | March 2018 |
| Contact: | Bethany Bell |
| Email: | bbell@alpco.com |
| Phone: | 1-800-592-5726 |
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.
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.
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.
We found this trial at
1
site
