Inflammatory Bowel DiseasesNCT03082287
ALPCO Calprotectin ELISA - Measurement of Calprotectin Levels in Human Stool
An observational study of Inflammatory Bowel Diseases and Irritable Bowel Syndrome, run by American Laboratory Products Company at 1 site in United States.
Trial summary
The ALPCO Calprotectin ELISA 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 Diseases, Irritable Bowel Syndrome
- What is being tested?
- Fecal Calprotectin Level
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 424 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2017to 25 Oct 2019
- 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: Individuals that presents with symptoms of IBS/IBD and otherwise healthy subjects
Who may be able to join
- >18 years of age
- Patient must present with signs and symptoms of IBS or IBD
- Patient must be scheduled for a colonoscopy
- All results of the colonoscopy including histology must be provided to study site and sponsor.
- Medical Chart review may be required to confirm diagnosis of IBS or IBD
- Patient must not have taken NSAIDs for at least 2 weeks prior to participating in the study. Patients may be advised of the study and if report taking NSAIDS may be enrolled in the study after the patient has stopped use of NSAIDS for a minimum of 2 weeks.
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- For normal patient population - study participants must present with no signs or symptoms of IBS or IBD, must not have taken NSAIDs for at least a period of 2 weeks and must be willing to provide a stool sample.
- Sample must be collected at least 2-3 days prior to colonoscopy
- Male or female, ≥18 years of age.
- No abdominal complaints and no history of IBS, IBD, or other chronic intestinal disorder, confirmed by medical history and physical examination at enrollment.
- May have undergone colonoscopy with negative findings within the past 1 month or may have no recent colonoscopy, but scheduled for routine screening colonoscopy.
- Able to understand the study and the task required, and sign the ICF.
Who cannot join
- patient under the age of 18
- Patient taking NSAIDs
- Patients not presenting with signs or symptoms of IBS or IBD with the exception of 100 normal patients to be included in the study. Fifty (50) presenting for routine colonoscopy and 50 patients presenting with no disease symptoms and not scheduled for a colonoscopy.
- Patients not scheduled to have an colonoscopy unless enrolled in the study as normal population
- Unable or unwilling to provide a stool specimen.
- Have taken protein pump inhibitors (PPIs) or H2-receptor antagonists for control of upper GI disease within the previous 2 weeks.
- Have taken NSAIDs (including aspirin) on within 2 weeks of study enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
The ALPCO Calprotectin ELISA 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. This study will estimate the predictive values of a negative (NPV) and positive (PPV) test by utilizing the assay outcomes of the ALPCO Calprotectin ELISA.
- Being tested
- Fecal Calprotectin Level
- Medical subject headings
- Inflammatory Bowel Diseases, Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Calprotectin LevelDevice
Measurement of calprotectin in feces
| Study group | Role | What they receive |
|---|---|---|
| IBD | Adult subjects diagnosed with IBD via endoscopy and histological findings. Receives: Device: Fecal Calprotectin Level | |
| IBS | Adult subjects with IBS as per the Rome IV criteria. Receives: Device: Fecal Calprotectin Level | |
| Other GI Disorders | Adult subjects with gastrointestinal disorders not meeting the Rome IV criteria or IBD diagnosis. Receives: Device: Fecal Calprotectin Level | |
| Healthy Subjects | Adult subjects without any gastrointestinal complaints. Receives: Device: Fecal Calprotectin Level |
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 in the ELISA
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 posted17 Mar 2017
- Study start1 May 2017
- Primary completion25 Oct 2019
- Study completion25 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies 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
- 424 participants (actual)
Sponsor and investigators
- Lead sponsor
- American Laboratory Products Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MDC Associates, LLC
- Responsible party
- Sponsor
- Investigators
- Fran White, Study director, MDC Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03082287
- Sponsor's protocol ID
- ALPCOCAL
- Status last verified
- Nov 2019
- First submitted
- 6 Mar 2017
- Last updated
- 5 Nov 2019
- 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 5 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ALPCO Calprotectin ELISA - Measurement of Calprotectin Levels in Human Stool
- ClinicalTrials.gov ID
- NCT03082287
- Acronym / sponsor ID
- ALPCOCAL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 424 participants (actual)
- Lead sponsor
- American Laboratory Products CompanyIndustry (pharma, biotech, devices)
- Collaborators
- MDC Associates, LLC
- Study start
- 1 May 2017 (actual)
- Primary completion
- 25 Oct 2019 (actual)
- Study completion
- 25 Oct 2019 (actual)
- First posted
- 17 Mar 2017 (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 ELISA 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. This study will estimate the predictive values of a negative (NPV) and positive (PPV) test by utilizing the assay outcomes of the ALPCO Calprotectin ELISA.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| IBD | – | Device: Fecal Calprotectin LevelAdult subjects diagnosed with IBD via endoscopy and histological findings. |
| IBS | – | Device: Fecal Calprotectin LevelAdult subjects with IBS as per the Rome IV criteria. |
| Other GI Disorders | – | Device: Fecal Calprotectin LevelAdult subjects with gastrointestinal disorders not meeting the Rome IV criteria or IBD diagnosis. |
| Healthy Subjects | – | Device: Fecal Calprotectin LevelAdult 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 (12 listed)
- >18 years of age
- Patient must present with signs and symptoms of IBS or IBD
- Patient must be scheduled for a colonoscopy
- All results of the colonoscopy including histology must be provided to study site and sponsor.
- Medical Chart review may be required to confirm diagnosis of IBS or IBD
Key exclusion criteria (7 listed)
- patient under the age of 18
- Patient taking NSAIDs
- Patients not presenting with signs or symptoms of IBS or IBD with the exception of 100 normal patients to be included in the study. Fifty (50) presenting for routine colonoscopy and 50 patients presenting with no disease symptoms and not scheduled for a colonoscopy.
- Patients not scheduled to have an colonoscopy unless enrolled in the study as normal population
- Unable or unwilling to provide a stool specimen.
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 |
|---|---|---|
| Fecal Calprotectin LevelMeasurement 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 in the ELISA
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 5 Nov 2019.
- 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.
Fran White study director
MDC Associates
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 Inflammatory Bowel Diseases and 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 12 inclusion and 7 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 5 Nov 2019. 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?
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 5 Nov 2019.