Not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.
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Crohn'sUCRecruiting

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

Observational · No treatment assigned · 3 sites · American Laboratory Products Company

Official record & contacts on ClinicalTrials.gov ↗

In plain English

What this trial is testing

Condition(s) listed: Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis) and Inflammatory Bowel Syndrome. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.

Who can join

Some of the main requirements, copied from the record:

Plus 1 more requirement(s). There are also 11 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.

What's involved

Main thing being measured

In the researchers’ words

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.

This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.

Questions to ask your doctor and the trial team

Official details

StatusRecruiting
PhaseObservational
Study typeObservational
ConditionsInflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis); Inflammatory Bowel Syndrome
Lead sponsorAmerican Laboratory Products Company
Enrollment220 (estimated)
Start date2025-03-25
Primary completion (est.)2026-12-31
First posted2025-02-05
Last updated2026-04-28
Official titleALPCO Calprotectin CLIA Assay - Measurement of Calprotectin Levels in Human Stool
ClinicalTrials.gov IDNCT06810518

Interventions

Full eligibility criteria (from the record)
Inclusion criteria:

* Male or female, ≥22 years of age (adults)
* Suspected inflammatory bowel disease or irritable bowel syndrome with symptoms such as abdominal pain, diarrhea, altered appetite, weight loss, or anemia
* Able to provide a sample according to the sampling protocol within 72-24 hours prior to the scheduled diagnostic endoscopy or 3-30 days after the colonoscopy.
* Able to understand the study and the tasks required and sign the ICF

Exclusion criteria:

* 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 receiving chemotherapy or systemic immunosuppressive drugs without completing an 8-week washout period
* IBD patients who have previously diagnosed IBD managed with immunomodulators, 5-ASA or biologic therapies without completing an 8-week washout period for biologics and immunomodulators or 4 weeks for 5-ASA
* IBD patients who have previously been diagnosed with IBD and have undergone a surgical resection or diversion procedure.
* Known upper Gl disease such as esophagitis or gastritis that might influence the study test's ability to detect intestinal inflammatory disease
* Have taken NSAIDS (including aspirin) on 7 or more days during the 2 weeks before providing the sample
* Samples are not collected according to sampling protocol.
* Any condition that in the opinion of the investigator should preclude participation in the study.

Using an IRB approved consent form, all study participants will be advised of study requirements and potential risks associated with study participation.

Locations (3)

SiteCityCountrySite status
Med-Care Research CorpMiami, FloridaUnited StatesRecruiting
ALPCOSalem, New HampshireUnited StatesNot yet recruiting
Gastro Intestinal Research Institute of Northern Ohio,Westlake, OhioUnited StatesRecruiting

For contacts at each site, use the official record.

Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.