Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis)NCT06810518
ALPCO Calprotectin CLIA Assay - Measurement of Calprotectin Levels in Human Stool
An observational study of Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis) and Inflammatory Bowel Syndrome, run by American Laboratory Products Company at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis), Inflammatory Bowel Syndrome
- What is being tested?
- ALPCO Calprotectin CLIA
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 1,000 participants
- Where
- 3 sitesUnited States
- Study dates
- 25 Mar 2025to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals that presents with symptoms of IBS/IBD and otherwise healthy subjects
Who may be able to join
- Male or female, ≥22 years of age (adults)
- Subjects with suspected inflammatory bowel disease or irritable bowel syndrome presenting one or more of the following symptoms: abdominal pain, diarrhea, altered appetite, anemia, or unexpected weight loss. Not all symptoms are required; clinical presentation must support suspicion of inflammatory bowel disease or irritable bowel syndrome in the investigator's opinion.
- Able to provide a sample either within 14 days before beginning bowel preparation for the scheduled colonoscopy, or between 3 and 14 days after the colonoscopy.
- Able to understand the study and the tasks required and sign the ICF
Who cannot join
- 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)
- Subjects receiving chemotherapy or systemic immunosuppressive drugs without completing an 8-week washout period IBD patients who have previously diagnosed with 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 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.
Show all 10Show fewer
- 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.
- Samples are not collected according to sampling protocol.
- Any condition that in the opinion of the investigator should preclude participation in the study.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Med-Care Research Corp
Miami, Florida, 33125
- Not yet recruiting
ALPCO
Salem, New Hampshire, 03079
- Recruiting
Gastro Intestinal Research Institute of Northern Ohio,
Westlake, Ohio, 44145
About this study
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.
Read the detailed description
The clinical study serves to confirm the sensitivity and specificity of the ALPCO Calprotectin CLIA as compared to gastroenterologist diagnosis (including colonoscopy results and other clinical information) in patients with signs and symptoms of IBS or IBD, using the proposed cut-off values (50 and 100 µg/g) as both an aid in the diagnosis of Inflammatory Bowel Disease and as an aid to differentiate IBD from Irritable Bowel Syndrome. The clinical study will be conducted in compliance with applicable requirements in the protection of human subjects regulations in 21 CFR part 50, the institutional review boards regulations in 21 CFR part 56, and the investigational device exemptions regulations in 21 CFR part 812.
The goal of this clinical study is to confirm the sensitivity and specificity of the ALPCO Calprotectin CLIA in patients using the proposed cut-off value (50 µg/g) as an aid in differentiating between a diagnosis of an Inflammatory Bowel Disease and other non-inflammatory disorders, most notably Irritable Bowel Syndrome. (See Appendix I for draft study protocol). Final assay cut-off will be determined upon completion of analytical studies and product validation.
Calprotectin values greater than 50 µg/g (or defined assay cut-off) are indicative of neutrophil infiltrate in the gastrointestinal tract, and therefore signal the presence of an active Inflammatory Bowel Disease. Calprotectin concentrations below this value do not indicate inflammation, but do not eliminate a potential diagnosis of Irritable Bowel Syndrome. Therefore, clinical use of the ALPCO Calprotectin CLIA can generate crucial data to determine whether or not a patient should undergo more invasive testing to diagnose the presence of an Inflammatory Bowel Disease. This clinical study will seek to confirm this conclusion by estimating the predictive value of positive and negative tests using the proposed cut off value in patients referred for diagnostic evaluation with signs and symptoms suggestive of either IBD or IBS.
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.
This study will be performed at multiple clinical recruiting sites with a minimum of 3 analytical test sites - ALPCO would be one test site and could test all samples from collection sites only at which endoscopies (colonoscopy) focusing on the diagnosis of bowel inflammation are performed. Patients will be enrolled in the study based on inclusion/exclusion defined criteria.
All patients enrolled in the study with signs and symptoms of IBS or IBD, must provide a stool sample prior to having a scheduled endoscopy performed or shortly after the colonoscopy provided treatment has not begun and other inclusion/exclusion criteria have been met.
Patients enrolled in the study will be scheduled for a colonoscopy or would have had a colonoscopy in the timeframe listed in the inclusion criteria.
Results of the colonoscopy and histology will be used to determine disease status. Stool samples will be stored frozen until such time that they can be tested with the candidate device to determine the calprotectin measured value. Results of the ALPCO Calprotectin CLIA will be compared to the diagnosis obtained during the colonoscopy.
Agreement will be defined as follows:
A proposed cut-off of >50 µg/g Calprotectin represents a positive result indicating potential disease. A positive result must be confirmed by colonoscopy results indicating IBD. < 50 µg/g indicates a negative result.
Based on historical recruiting experience, approximately 220 or more patients with suspected IBD will be enrolled in the study with the goal of testing and enrolling
- approximately 70 patients with a confirmed diagnosis of IBD (Crohn's Disease or Ulcerative Colitis);
- approximately 100 patients with a confirmed diagnosis of Irritable Bowel Syndrome;
- approximately 50 patients with IBD symptoms but a diagnosis of something other than IBD or IBS
All enrolled patients must meet the inclusion criteria for the appropriate study group and must provide a stool sample in accordance with protocol requirements. Additionally, we will recruit approximately 100 normal patients that will be tested only with the ALPCO Calprotectin CLIA. The normal patient groups will have no history of disease.
- Conditions
- Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis), Inflammatory Bowel Syndrome
- Being tested
- ALPCO Calprotectin CLIA
- Keywords
- calprotectin, IBD, IBS
- Medical subject headings
- Inflammatory Bowel Diseases, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALPCO Calprotectin CLIADevice
Measurement of calprotectin in feces
| Study group | Role | What they receive |
|---|---|---|
| IBD | Adult subjects diagnosed with IBD via endoscopy and histological findings. Receives: Device: ALPCO Calprotectin CLIA | |
| IBS | Adult subjects with IBS as per the Rome IV criteria. Receives: Device: ALPCO Calprotectin CLIA | |
| Other GI Disorders | Adult subjects with gastrointestinal disorders not meeting the Rome IV criteria or IBD diagnosis. Receives: Device: ALPCO Calprotectin CLIA | |
| Healthy Subjects | Adult subjects without any gastrointestinal complaints. Receives: Device: ALPCO Calprotectin CLIA |
What is being measured
The primary outcome is the main question the study is designed to answer.
In vitro diagnostic value of Calprotectin
Value of calprotectin measurement using the ALPCO Calprotectin CLIA on the chemiluminescent automated KleeYa instrument.
Measured: Through study completion, up to 52 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start25 Mar 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American Laboratory Products Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06810518
- Sponsor's protocol ID
- CPSP-2025-010
- Status last verified
- Oct 2026
- First submitted
- 31 Jan 2025
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ALPCO Calprotectin CLIA Assay - Measurement of Calprotectin Levels in Human Stool
- ClinicalTrials.gov ID
- NCT06810518
- Acronym / sponsor ID
- CPSP-2025-010
- Conditions
- Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis), Inflammatory Bowel Syndrome
- Keywords
- calprotectin, IBD, IBS
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- American Laboratory Products CompanyIndustry (pharma, biotech, devices)
- Study start
- 25 Mar 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The clinical study serves to confirm the sensitivity and specificity of the ALPCO Calprotectin CLIA as compared to gastroenterologist diagnosis (including colonoscopy results and other clinical information) in patients with signs and symptoms of IBS or IBD, using the proposed cut-off values (50 and 100 µg/g) as both an aid in the diagnosis of Inflammatory Bowel Disease and as an aid to differentiate IBD from Irritable Bowel Syndrome. The clinical study will be conducted in compliance with applicable requirements in the protection of human subjects regulations in 21 CFR part 50, the institutional review boards regulations in 21 CFR part 56, and the investigational device exemptions regulations in 21 CFR part 812.
The goal of this clinical study is to confirm the sensitivity and specificity of the ALPCO Calprotectin CLIA in patients using the proposed cut-off value (50 µg/g) as an aid in differentiating between a diagnosis of an Inflammatory Bowel Disease and other non-inflammatory disorders, most notably Irritable Bowel Syndrome. (See Appendix I for draft study protocol). Final assay cut-off will be determined upon completion of analytical studies and product validation.
Calprotectin values greater than 50 µg/g (or defined assay cut-off) are indicative of neutrophil infiltrate in the gastrointestinal tract, and therefore signal the presence of an active Inflammatory Bowel Disease. Calprotectin concentrations below this value do not indicate inflammation, but do not eliminate a potential diagnosis of Irritable Bowel Syndrome. Therefore, clinical use of the ALPCO Calprotectin CLIA can generate crucial data to determine whether or not a patient should undergo more invasive testing to diagnose the presence of an Inflammatory Bowel Disease. This clinical study will seek to confirm this conclusion by estimating the predictive value of positive and negative tests using the proposed cut off value in patients referred for diagnostic evaluation with signs and symptoms suggestive of either IBD or IBS.
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.
This study will be performed at multiple clinical recruiting sites with a minimum of 3 analytical test sites - ALPCO would be one test site and could test all samples from collection sites only at which endoscopies (colonoscopy) focusing on the diagnosis of bowel inflammation are performed. Patients will be enrolled in the study based on inclusion/exclusion defined criteria.
All patients enrolled in the study with signs and symptoms of IBS or IBD, must provide a stool sample prior to having a scheduled endoscopy performed or shortly after the colonoscopy provided treatment has not begun and other inclusion/exclusion criteria have been met.
Patients enrolled in the study will be scheduled for a colonoscopy or would have had a colonoscopy in the timeframe listed in the inclusion criteria.
Results of the colonoscopy and histology will be used to determine disease status. Stool samples will be stored frozen until such time that they can be tested with the candidate device to determine the calprotectin measured value. Results of the ALPCO Calprotectin CLIA will be compared to the diagnosis obtained during the colonoscopy.
Agreement will be defined as follows:
A proposed cut-off of >50 µg/g Calprotectin represents a positive result indicating potential disease. A positive result must be confirmed by colonoscopy results indicating IBD. < 50 µg/g indicates a negative result.
Based on historical recruiting experience, approximately 220 or more patients with suspected IBD will be enrolled in the study with the goal of testing and enrolling
- approximately 70 patients with a confirmed diagnosis of IBD (Crohn's Disease or Ulcerative Colitis);
- approximately 100 patients with a confirmed diagnosis of Irritable Bowel Syndrome;
- approximately 50 patients with IBD symptoms but a diagnosis of something other than IBD or IBS
All enrolled patients must meet the inclusion criteria for the appropriate study group and must provide a stool sample in accordance with protocol requirements. Additionally, we will recruit approximately 100 normal patients that will be tested only with the ALPCO Calprotectin CLIA. The normal patient groups will have no history of disease.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| IBD | – | Device: ALPCO Calprotectin CLIAAdult subjects diagnosed with IBD via endoscopy and histological findings. |
| IBS | – | Device: ALPCO Calprotectin CLIAAdult subjects with IBS as per the Rome IV criteria. |
| Other GI Disorders | – | Device: ALPCO Calprotectin CLIAAdult subjects with gastrointestinal disorders not meeting the Rome IV criteria or IBD diagnosis. |
| Healthy Subjects | – | Device: ALPCO Calprotectin CLIAAdult subjects without any gastrointestinal complaints. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals that presents with symptoms of IBS/IBD and otherwise healthy subjects
Key inclusion criteria (4 listed)
- Male or female, ≥22 years of age (adults)
- Subjects with suspected inflammatory bowel disease or irritable bowel syndrome presenting one or more of the following symptoms: abdominal pain, diarrhea, altered appetite, anemia, or unexpected weight loss. Not all symptoms are required; clinical presentation must support suspicion of inflammatory bowel disease or irritable bowel syndrome in the investigator's opinion.
- Able to provide a sample either within 14 days before beginning bowel preparation for the scheduled colonoscopy, or between 3 and 14 days after the colonoscopy.
- Able to understand the study and the tasks required and sign the ICF
Key exclusion criteria (10 listed)
- 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)
- Subjects receiving chemotherapy or systemic immunosuppressive drugs without completing an 8-week washout period IBD patients who have previously diagnosed with 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 surgical resection or diversion procedure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALPCO Calprotectin CLIAMeasurement of calprotectin in feces | Device | Healthy Subjects, IBD, IBS, Other GI Disorders |
Primary outcome
In vitro diagnostic value of Calprotectin
Time frame: Through study completion, up to 52 weeks.
Value of calprotectin measurement using the ALPCO Calprotectin CLIA on the chemiluminescent automated KleeYa instrument.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis) and Inflammatory Bowel Syndrome, run by American Laboratory Products Company at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yomi Ojutalayo (800-592-5726, clinops@alpco.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In vitro diagnostic value of Calprotectin (time frame: Through study completion, up to 52 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.