IBD (Inflammatory Bowel Disease)NCT07089420
ALPCO/Calprotectin CLIA Assay: Expected Values of Calprotectin in Healthy Subjects
An observational study of IBD (Inflammatory Bowel Disease) and IBS - Irritable Bowel Syndrome, run by American Laboratory Products Company at 1 site in United States.
Trial summary
This study is evaluating the levels of calprotectin, a protein found in stool, in healthy adults. Calprotectin is a marker of inflammation in the intestines and can help doctors tell the difference between inflammatory bowel diseases (IBD), like Crohn's disease or ulcerative colitis, and non-inflammatory conditions… Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- IBD (Inflammatory Bowel Disease), IBS - Irritable Bowel Syndrome, Crohn Disease (CD)
- What is being tested?
- ALPCO Calprotectin CLIA
- Type of treatment
- Medical device
- How many people
- 121 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2025to 15 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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: The study will enroll approximately 120 to 150 healthy adult volunteers, aged 22 years or older, from the general U.S. population. Participants must be asymptomatic with no history of inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), gastrointestinal cancer, or other chronic intestinal conditions. Subjects must not be on immunosuppressive therapy, PPIs, H2 blockers, or regular NSAID use prior to sample collection. The goal is to represent a normal, healthy population to establish baseline calprotectin levels using the ALPCO Calprotectin CLIA assay.
Who may be able to join
- Adults aged ≥22 years
- No abdominal symptoms and no history of inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), or other chronic intestinal disorders
- May have undergone colonoscopy with negative findings within the past month or never undergone colonoscopy
- Able and willing to provide a stool sample according to the collection protocol
- Able to understand the study and sign the informed consent form (ICF)
Who cannot join
- Unable or unwilling to provide a stool sample
- Known active intestinal cancer or history of intestinal cancer with abnormal clinical findings
- Currently receiving chemotherapy or systemic immunosuppressive medications
- Use of proton pump inhibitors (PPIs) or H2-receptor antagonists within the last 2 weeks
- Use of NSAIDs (including aspirin) for 7 or more days in the past 2 weeks
- Presence of gastrointestinal symptoms such as abdominal pain, diarrhea, altered appetite, weight loss, or anemia
- Samples collected not following protocol requirements
- Any other condition that, in the opinion of the investigator, may interfere with study participation or data validity
Trial locations and contacts
1 site in 1 country.
About this study
This study is evaluating the levels of calprotectin, a protein found in stool, in healthy adults. Calprotectin is a marker of inflammation in the intestines and can help doctors tell the difference between inflammatory bowel diseases (IBD), like Crohn's disease or ulcerative colitis, and non-inflammatory conditions like irritable bowel syndrome (IBS).
In this study, healthy volunteers aged 22 and older will collect a stool sample at home using a simple kit and mail it to the study site. The samples will be tested using a new laboratory method called the ALPCO Calprotectin CLIA assay. The goal is to confirm what level of calprotectin is considered "normal" in people without intestinal disease.
Participation involves just one stool sample, and there are no medical procedures. Volunteers will be compensated for their time. The study will help improve how doctors interpret calprotectin test results in clinical settings.
Read the detailed description
This study is designed to evaluate the expected (normal) values of calprotectin in the stool of healthy adults using the ALPCO Calprotectin CLIA assay, an investigational in vitro diagnostic test. Calprotectin is a protein released during intestinal inflammation and is commonly used as a non-invasive biomarker to assess gastrointestinal diseases. Elevated levels of fecal calprotectin can indicate active inflammation, particularly in patients with inflammatory bowel disease (IBD), such as Crohn's disease or ulcerative colitis. Conversely, low levels are typically associated with non-inflammatory conditions like irritable bowel syndrome (IBS).
The purpose of this study is to establish baseline (expected) calprotectin levels in individuals who do not have symptoms of IBD, IBS, or other chronic intestinal conditions. These expected values are essential to validate the performance of the ALPCO Calprotectin CLIA assay and to guide its use in differentiating inflammatory and non-inflammatory gastrointestinal conditions in clinical practice.
Approximately 120-150 healthy adult volunteers, aged 22 and older, will be enrolled at 1-2 U.S. clinical sites. Eligible participants will not have any history of chronic intestinal disorders, cancer, recent use of NSAIDs or GI medications, or active gastrointestinal symptoms. After providing informed consent, each participant will collect a stool sample at home using a provided sample collection kit. The sample will be returned to ALPCO by mail or delivery, where it will be analyzed in a laboratory using the study assay.
Stool samples will be processed, stored, and tested according to standardized procedures. The results of this study will be used to determine the reference cut-off value for a healthy population (currently hypothesized at 50 µg/g) and to support the performance claims of the ALPCO Calprotectin CLIA assay in future regulatory submissions.
Participants will be compensated for their participation. There is no direct medical benefit to participants, and the test results will not be shared with them. All samples and data will be handled confidentially, in accordance with Good Clinical Practice (GCP), U.S. FDA regulations, and HIPAA.
- Conditions
- IBD (Inflammatory Bowel Disease), IBS - Irritable Bowel Syndrome, Crohn Disease (CD), UC - Ulcerative Colitis
- Being tested
- ALPCO Calprotectin CLIA
- Keywords
- Calprotectin, IBD, IBS
- Medical subject headings
- Inflammatory Bowel Diseases, Irritable Bowel Syndrome, Crohn Disease, 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 |
|---|---|---|
| Healthy Adult Volunteers | This group will include approximately 120 to 150 asymptomatic, healthy adults aged 22 years or older. Participants must have no history of inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), gastrointestinal cancer, or chronic intestinal disorders. They must not be taking immunosuppressive therapy, proton pump inhibitors, H2 blockers, or NSAIDs as outlined in the exclusion criteria.
Participants will collect a single stool sample at home using a provided kit and ship it to the sponsor site (ALPCO) for laboratory analysis. The stool samples will be tested using the ALPCO Calprotectin CLIA assay, a chemiluminescent immunoassay designed to measure fecal calprotectin levels. This group serves to establish reference (expected) calprotectin values in healthy individuals, which will support assay validation and performance claims. Receives: Device: ALPCO Calprotectin CLIA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish the Expected Reference Range for Fecal Calprotectin in Healthy Adults
Determine the distribution and expected (normal) reference range of fecal calprotectin concentrations in healthy adults using the ALPCO Calprotectin CLIA assay. The outcome will confirm whether the predefined clinical cut-off value of <50 µg/g accurately reflects a non-inflammatory baseline in an asymptomatic population.
Measured: Within 2 months of sample collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start7 Jul 2025
- Primary completion15 Apr 2026
- Study completion15 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBD (Inflammatory Bowel Disease)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
- Prospective
- Enrolment
- 121 participants (actual)
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
- NCT07089420
- Sponsor's protocol ID
- CPSP-2025-011
- Status last verified
- Apr 2026
- First submitted
- 21 Jul 2025
- Last updated
- 28 Apr 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 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ALPCO/Calprotectin CLIA Assay: Expected Values of Calprotectin in Healthy Subjects
- ClinicalTrials.gov ID
- NCT07089420
- Acronym / sponsor ID
- CPSP-2025-011
- Conditions
- IBD (Inflammatory Bowel Disease), IBS - Irritable Bowel Syndrome, Crohn Disease (CD), UC - Ulcerative Colitis
- Keywords
- Calprotectin, IBD, IBS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- American Laboratory Products CompanyIndustry (pharma, biotech, devices)
- Study start
- 7 Jul 2025 (actual)
- Primary completion
- 15 Apr 2026 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 28 Jul 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.
This study is evaluating the levels of calprotectin, a protein found in stool, in healthy adults. Calprotectin is a marker of inflammation in the intestines and can help doctors tell the difference between inflammatory bowel diseases (IBD), like Crohn's disease or ulcerative colitis, and non-inflammatory conditions like irritable bowel syndrome (IBS).
In this study, healthy volunteers aged 22 and older will collect a stool sample at home using a simple kit and mail it to the study site. The samples will be tested using a new laboratory method called the ALPCO Calprotectin CLIA assay. The goal is to confirm what level of calprotectin is considered "normal" in people without intestinal disease.
Participation involves just one stool sample, and there are no medical procedures. Volunteers will be compensated for their time. The study will help improve how doctors interpret calprotectin test results in clinical settings.
Detailed description
This study is designed to evaluate the expected (normal) values of calprotectin in the stool of healthy adults using the ALPCO Calprotectin CLIA assay, an investigational in vitro diagnostic test. Calprotectin is a protein released during intestinal inflammation and is commonly used as a non-invasive biomarker to assess gastrointestinal diseases. Elevated levels of fecal calprotectin can indicate active inflammation, particularly in patients with inflammatory bowel disease (IBD), such as Crohn's disease or ulcerative colitis. Conversely, low levels are typically associated with non-inflammatory conditions like irritable bowel syndrome (IBS).
The purpose of this study is to establish baseline (expected) calprotectin levels in individuals who do not have symptoms of IBD, IBS, or other chronic intestinal conditions. These expected values are essential to validate the performance of the ALPCO Calprotectin CLIA assay and to guide its use in differentiating inflammatory and non-inflammatory gastrointestinal conditions in clinical practice.
Approximately 120-150 healthy adult volunteers, aged 22 and older, will be enrolled at 1-2 U.S. clinical sites. Eligible participants will not have any history of chronic intestinal disorders, cancer, recent use of NSAIDs or GI medications, or active gastrointestinal symptoms. After providing informed consent, each participant will collect a stool sample at home using a provided sample collection kit. The sample will be returned to ALPCO by mail or delivery, where it will be analyzed in a laboratory using the study assay.
Stool samples will be processed, stored, and tested according to standardized procedures. The results of this study will be used to determine the reference cut-off value for a healthy population (currently hypothesized at 50 µg/g) and to support the performance claims of the ALPCO Calprotectin CLIA assay in future regulatory submissions.
Participants will be compensated for their participation. There is no direct medical benefit to participants, and the test results will not be shared with them. All samples and data will be handled confidentially, in accordance with Good Clinical Practice (GCP), U.S. FDA regulations, and HIPAA.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Adult Volunteers | – | Device: ALPCO Calprotectin CLIAThis group will include approximately 120 to 150 asymptomatic, healthy adults aged 22 years or older. Participants must have no history of inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), gastrointestinal cancer, or chronic intestinal disorders. They must not be taking immunosuppressive therapy, proton pump inhibitors, H2 blockers, or NSAIDs as outlined in the exclusion criteria. Participants will collect a single stool sample at home using a provided kit and ship it to the sponsor site (ALPCO) for laboratory analysis. The stool samples will be tested using the ALPCO Calprotectin CLIA assay, a chemiluminescent immunoassay designed to measure fecal calprotectin levels. This group serves to establish reference (expected) calprotectin values in healthy individuals, which will support assay validation and performance claims. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study will enroll approximately 120 to 150 healthy adult volunteers, aged 22 years or older, from the general U.S. population. Participants must be asymptomatic with no history of inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), gastrointestinal cancer, or other chronic intestinal conditions. Subjects must not be on immunosuppressive therapy, PPIs, H2 blockers, or regular NSAID use prior to sample collection. The goal is to represent a normal, healthy population to establish baseline calprotectin levels using the ALPCO Calprotectin CLIA assay.
Key inclusion criteria (5 listed)
- Adults aged ≥22 years
- No abdominal symptoms and no history of inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), or other chronic intestinal disorders
- May have undergone colonoscopy with negative findings within the past month or never undergone colonoscopy
- Able and willing to provide a stool sample according to the collection protocol
- Able to understand the study and sign the informed consent form (ICF)
Key exclusion criteria (8 listed)
- Unable or unwilling to provide a stool sample
- Known active intestinal cancer or history of intestinal cancer with abnormal clinical findings
- Currently receiving chemotherapy or systemic immunosuppressive medications
- Use of proton pump inhibitors (PPIs) or H2-receptor antagonists within the last 2 weeks
- Use of NSAIDs (including aspirin) for 7 or more days in the past 2 weeks
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 Adult Volunteers |
Primary outcome
Establish the Expected Reference Range for Fecal Calprotectin in Healthy Adults
Time frame: Within 2 months of sample collection
Determine the distribution and expected (normal) reference range of fecal calprotectin concentrations in healthy adults using the ALPCO Calprotectin CLIA assay. The outcome will confirm whether the predefined clinical cut-off value of <50 µg/g accurately reflects a non-inflammatory baseline in an asymptomatic population.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of IBD (Inflammatory Bowel Disease) and IBS - Irritable Bowel Syndrome, run by American Laboratory Products Company at 1 site 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 5 inclusion and 8 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: finished, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establish the Expected Reference Range for Fecal Calprotectin in Healthy Adults (time frame: Within 2 months of sample collection). 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 28 Apr 2026.