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Trial record 1 of 2 for:    Salem, New Hampshire, U.S.
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ALPCO Calprotectin ELISA - Measurement of Calprotectin Levels in Human Stool

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ClinicalTrials.gov Identifier: NCT03082287
Recruitment Status : Recruiting
First Posted : March 17, 2017
Last Update Posted : July 3, 2019
Sponsor:
Collaborator:
MDC Associates, LLC
Information provided by (Responsible Party):
American Laboratory Products Company

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.

Condition or disease Intervention/treatment
Inflammatory Bowel Diseases Irritable Bowel Syndrome Device: Fecal Calprotectin Level

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: ALPCO Calprotectin ELISA - Measurement of Calprotectin Levels in Human Stool
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Group/Cohort Intervention/treatment
IBD
Adult subjects diagnosed with IBD via endoscopy and histological findings.
Device: Fecal Calprotectin Level
Measurement of calprotectin in feces

IBS
Adult subjects with IBS as per the Rome IV criteria.
Device: Fecal Calprotectin Level
Measurement of calprotectin in feces

Other GI Disorders
Adult subjects with gastrointestinal disorders not meeting the Rome IV criteria or IBD diagnosis.
Device: Fecal Calprotectin Level
Measurement of calprotectin in feces

Healthy Subjects
Adult subjects without any gastrointestinal complaints.
Device: Fecal Calprotectin Level
Measurement of calprotectin in feces




Primary Outcome Measures :
  1. In vitro diagnostic value of Calprotectin [ Time Frame: Through study completion, up to 52 weeks. ]
    Value of calprotectin measurement in the ELISA


Biospecimen Retention:   Samples Without DNA
Stool


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Individuals that presents with symptoms of IBS/IBD and otherwise healthy subjects
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03082287


Contacts
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Contact: Bethany Bell 1-800-592-5726 ext 260 bbell@alpco.com
Contact: Chris Wisherd 1-800-592-5726 ext 221 cwisherd@alpco.com

Locations
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United States, New Hampshire
ALPCO Recruiting
Salem, New Hampshire, United States, 03079
Contact: Bethany Bell       bbell@alpco.com   
Contact: Chris Wisherd       cwisherd@alpco.com   
Sponsors and Collaborators
American Laboratory Products Company
MDC Associates, LLC
Investigators
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Study Director: Fran White MDC Associates

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Responsible Party: American Laboratory Products Company
ClinicalTrials.gov Identifier: NCT03082287     History of Changes
Other Study ID Numbers: ALPCOCAL
First Posted: March 17, 2017    Key Record Dates
Last Update Posted: July 3, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Inflammatory Bowel Diseases
Irritable Bowel Syndrome
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Colonic Diseases, Functional
Colonic Diseases