RecruitingNot a traditional drug phaseobservationalRules rewrite

Not a traditional drug phase: ALPCO Calprotectin CLIA for Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis)

The ALPCO Calprotectin CLIA 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.

Official registry: https://clinicaltrials.gov/study/NCT06810518 · American Laboratory Products Company · enrollment listed as 1,000

What this phase means

This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.

They plan to enroll about 1,000 people at 3 sites. Taking part typically means using or being fitted with a device plus check-ins.

Official title (unrewritten)

ALPCO Calprotectin CLIA Assay - Measurement of Calprotectin Levels in Human Stool

Interventions: ALPCO Calprotectin CLIA

Primary outcome (registry wording): In vitro diagnostic value of Calprotectin

Who it is for (from inclusion criteria)

Ages 22 Years to any
Male or female, ≥22 years of age (adults)

Who the registry excludes

Unable or unwilling to provide a stool specimen
Known active intestinal cancer or in remission with abnormal levels (per physician assessment)
Known active intestinal infection or history of treated intestinal infection with persistent abnormal levels (per physician assessment)
IBD patients who have previously been diagnosed with IBD and have undergone surgical resection or diversion procedure
Current or active upper gastrointestinal disease (e.g., esophagitis, gastritis, GERD, or acid reflux) with ongoing symptoms or requiring active treatment
Use of proton pump inhibitors (PPIs) or H2-receptor antagonists within the 2 weeks prior to providing the stool sample
Use of NSAIDs, including aspirin, on seven or more days within the 14 days prior to sample collection

Public study contact (from the registry)

Yomi Ojutalayo

800-592-5726

clinops@alpco.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

3 listed

Med-Care Research Corp — Miami, Florida (recruiting)
ALPCO — Salem, New Hampshire (not_yet_recruiting)
Gastro Intestinal Research Institute of Northern Ohio, — Westlake, Ohio (recruiting)

Related recruiting trials in this snapshot

RecruitingNot a traditional drug phaseLeuven, Vlaams-Brabant

Not a traditional drug phase: Sample collection for IBS

Aim: More insight in pathogenesis of IBS and IBD. Samples are collected in context of an European research project.

NCT02421705 · Official ClinicalTrials.gov record · KU Leuven

RecruitingPhase 1 / Phase 2Bethesda, Maryland

Phase 1 / Phase 2: testing Vorinostat for Crohn's Disease

Background: Crohn s disease (CD) is an inflammatory bowel disease. Symptoms may include diarrhea, abdominal pain, fatigue, weight loss and malnutrition.

NCT03167437 · Official ClinicalTrials.gov record · National Institute of Allergy and Infectious Diseases (NIAID)

RecruitingNot a traditional drug phaseRochester, Minnesota

Mucosal and Microbiota Changes During Acute Campylobacteriosis

Gastrointestinal (GI) infection with Campylobacter causes inflammation in the bowel and can change bacteria in the gut. Certain individuals with Campylobacter infection are also known to develop chronic bowel problems such as Irritable Bowel Syndrome (IBS).

NCT03223077 · Official ClinicalTrials.gov record · Mayo Clinic

FAQ about this NCT record

Is NCT06810518 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06810518?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06810518?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary

Not a traditional drug phase: ALPCO Calprotectin CLIA for Inflammatory Bowel Disease (Crohn&#39;s Disease and Ulcerative Colitis)