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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
22 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well the ALPCO Calprotectin stool test helps identify inflammatory bowel disease (IBD) and tell it apart from irritable bowel syndrome (IBS). The test measures a protein linked to swelling in the gut and is used with other tests. The study is for adults age 22 or older with symptoms of IBD or IBS.

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. 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. The goal of the study is to generate data to support positive and negative predictive value of the ALPCO Calprotectin assay in patients with signs and symptoms of IBS or IBD.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 22 or older.
  • May have IBD or IBS, with symptoms such as belly pain, diarrhea, appetite changes, weight loss, or anemia (low red blood cells).
  • Can give a stool sample as directed, 24–72 hours before a planned endoscopy (a camera exam of the gut) or 3–30 days after a colonoscopy (a camera exam of the colon).
  • Can understand the study and required tasks and sign a consent form.

Who can't join

  • Cannot or will not give a stool sample, or the sample is not collected as directed.
  • Have active intestinal cancer, or cancer in remission with abnormal levels, as judged by the doctor.
  • Have an active intestinal infection, or still have abnormal levels after treatment, as judged by the doctor.
  • Have IBD and have not stopped certain treatments for the required time: 8 weeks for chemotherapy, drugs that weaken the immune system throughout the body, immunomodulators, or biologics; 4 weeks for 5-ASA. These are treatments that may control inflammation or change how the immune system works.
  • Have diagnosed IBD and have had surgery to remove or reroute part of the bowel.
  • Have disease in the upper gut, such as swelling in the food pipe or stomach, that could affect the test.
  • Took NSAID pain medicines, including aspirin, on 7 or more days in the 2 weeks before giving the sample.
  • Have any other condition that the study doctor believes should prevent you from joining.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (3)

FL

NH

OH