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
- Ages 22 and older
- Any sex
- Healthy volunteers accepted
Some of the main requirements, copied from the record:
- 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.
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
- About 220 participants are expected to take part.
- Start date: 2025-03-25.
- Main results expected around 2026-12-31 (estimate from the record).
- 3 study sites listed (2 marked recruiting) in United States.
Main thing being measured
- In vitro diagnostic value of Calprotectin (Through study completion, up to 52 weeks.)
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
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis); Inflammatory Bowel Syndrome |
| Lead sponsor | American Laboratory Products Company |
| Enrollment | 220 (estimated) |
| Start date | 2025-03-25 |
| Primary completion (est.) | 2026-12-31 |
| First posted | 2025-02-05 |
| Last updated | 2026-04-28 |
| Official title | ALPCO Calprotectin CLIA Assay - Measurement of Calprotectin Levels in Human Stool |
| ClinicalTrials.gov ID | NCT06810518 |
Interventions
- ALPCO Calprotectin CLIA (Device)
Measurement of calprotectin in feces
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)
| Site | City | Country | Site status |
|---|---|---|---|
| Med-Care Research Corp | Miami, Florida | United States | Recruiting |
| ALPCO | Salem, New Hampshire | United States | Not yet recruiting |
| Gastro Intestinal Research Institute of Northern Ohio, | Westlake, Ohio | United States | Recruiting |
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.