Inflammatory Bowel DiseasesCALFENCT03143517
Fecal Calprotectin Collection Protocol
An observational study of Inflammatory Bowel Diseases and Irritable Bowel Syndrome, run by DiaSorin Inc. at 13 sites in United States.
Trial summary
The primary objective is to obtain stool samples from subjects diagnosed with , and displaying signs and/or symptoms of IBD and/or IBS will be evaluated in this study. Eligible subjects require a diagnostic colonoscopy with possible biopsy and clinical evaluation. Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases, Irritable Bowel Syndrome, Ulcerative Colitis
- What is being tested?
- Stool collection
- How many people
- 240 participants
- Where
- 13 sitesUnited States
- Study dates
- 19 Apr 2017to 23 Aug 2018
- 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 4 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adult subjects and belonging to the target population, i.e. patients diagnosed with IBD, specifically CD, UC, or IC, patients diagnosed with IBS, and patients diagnosed with other gastrointestinal diseases, e.g. Celiac Disease, Diverticular Disease, Chronic Diarrhea and Recurrent Abdominal Pain (RAP).
Who may be able to join
- Subject is of either gender and ≥ 4 years of age.
- Subject is showing signs and symptoms of IBD and/or IBS.
- Diagnosis of IBD, IBS or other gastrointestinal disorder is performed by colonoscopy.
- Subject or authorized legal representative is willing and able to sign the IRB approved Informed Consent form or able to provide Informed Consent in accordance with 21 CFR 50 CFR 50 Subpart B.
- Subject is able to understand and follow study sample collection procedure.
Who cannot join
- Subject has undergone a surgical resection or diversion procedure.
- Subject is currently taking NSAIDS (non-steroidal anti-inflammatory drugs, i.e. ibuprofen, Advil, Motrin, Naproxen, Aleve including regular dose and low dose aspirin) within 7 days of colonoscopy and sample collection.
- Subject who has taken immunomodulators or biologic therapies within the previous 6 months of colonoscopy and sample collection.
- Subject who is currently pregnant or lactating.
- Subject is unable or unwilling to follow informed consent.
- Inability or unwilling to perform required study procedures.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
One (1) Location in North Carolina
Asheville, North Carolina, 28801
One (1) Location in Atlanta, GA
Atlanta, Georgia, 30342
One (1) Location in Colorado Springs, Colorado
Colorado Springs, Colorado, 80907
One (1) Location in Dothan, Alabama
Dothan, Alabama, 36305
One (1) Location in Greenville, SC
Greenville, South Carolina, 29615
One (1) Location in Lauderdale Lakes, FL
Lauderdale Lakes, Florida, 33319
One (1) Facility in Arkansas
Little Rock, Arkansas, 72117
One (1) Location in Maitland, FL
Maitland, Florida, 32751
One (1) Location in Miami, Florida
Miami, Florida, 33134
One (1) Location in Minneapolis, MN
Minneapolis, Minnesota, 55455
One (1) Location in California
Mission Hills, California, 91345
One (1) Location in New York, New York
New York, New York, 33134
One (1) Location in St. Augustine, FL
Saint Augustine, Florida, 32086
About this study
Official title: CALFE Stool Sample Collection Protocol
The primary objective is to obtain stool samples from subjects diagnosed with , and displaying signs and/or symptoms of IBD and/or IBS will be evaluated in this study. Eligible subjects require a diagnostic colonoscopy with possible biopsy and clinical evaluation.
Read the detailed description
Stools will be collected and tested, at a later date, in a clinical performance study with an investigational Calprotectin assay. This study will be coordinated by the Sponsor.
- Conditions
- Inflammatory Bowel Diseases, Irritable Bowel Syndrome, Ulcerative Colitis, Crohn Disease, Indeterminate Colitis, Chronic Diarrhea
- Being tested
- Stool collection
- Keywords
- Inflammatory Bowel Diseases, Irritable Bowel Syndrome, Ulcerative Colitis, Crohn Disease, Indeterminate Colitis
- Medical subject headings
- Inflammatory Bowel Diseases, Irritable Bowel Syndrome, Colitis, Ulcerative, Crohn Disease, Celiac Disease, Diverticulitis, Abdominal Pain, Dilatation, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stool collectionDiagnostic test
Stool sample collected by a subject who have been diagnosed with IBD, IBS or other GI disorder. The stool sample is tested in a laboratory where fecal calprotectin levels are quantified.
| Study group | Role | What they receive |
|---|---|---|
| Inflammatory Bowel Disease (IBD) | A stool sample will be collected from adult subjects with Inflammatory Bowel Disease (IBD), confirmed by endoscopy and histologic examination. Receives: Diagnostic Test: Stool collection | |
| Irritable Bowel Syndrome (IBS) | A stool sample will be collected from adult subjects with adult subjects with Irritable Bowel Syndrome meeting the Rome III criteria. Receives: Diagnostic Test: Stool collection | |
| Other GastroIntestinal (GI) Disorders | A stool sample will be collected from adult subjects with adult subjects with gastrointestinal disorders other than IBD or IBS. Receives: Diagnostic Test: Stool collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calprotectin Stool Collection
In vitro diagnostic (IVD) device performance
Measured: Through Study Completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2017
- Study start19 Apr 2017
- Primary completion23 Aug 2018
- Study completion23 Aug 2018
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 only
- Time perspective
- Prospective
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- DiaSorin Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03143517
- Sponsor's protocol ID
- CALFE Sample Collection C-001
- Acronym
- CALFE
- Status last verified
- Feb 2019
- First submitted
- 4 May 2017
- Last updated
- 7 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CALFE Stool Sample Collection Protocol
- ClinicalTrials.gov ID
- NCT03143517
- Acronym / sponsor ID
- CALFE / CALFE Sample Collection C-001
- Conditions
- Inflammatory Bowel Diseases, Irritable Bowel Syndrome, Ulcerative Colitis, Crohn Disease, Indeterminate Colitis, Chronic Diarrhea
- Keywords
- Inflammatory Bowel Diseases, Irritable Bowel Syndrome, Ulcerative Colitis, Crohn Disease, Indeterminate Colitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- DiaSorin Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Apr 2017 (actual)
- Primary completion
- 23 Aug 2018 (actual)
- Study completion
- 23 Aug 2018 (actual)
- First posted
- 8 May 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 primary objective is to obtain stool samples from subjects diagnosed with , and displaying signs and/or symptoms of IBD and/or IBS will be evaluated in this study. Eligible subjects require a diagnostic colonoscopy with possible biopsy and clinical evaluation.
Detailed description
Stools will be collected and tested, at a later date, in a clinical performance study with an investigational Calprotectin assay. This study will be coordinated by the Sponsor.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Inflammatory Bowel Disease (IBD) | – | Diagnostic Test: Stool collectionA stool sample will be collected from adult subjects with Inflammatory Bowel Disease (IBD), confirmed by endoscopy and histologic examination. |
| Irritable Bowel Syndrome (IBS) | – | Diagnostic Test: Stool collectionA stool sample will be collected from adult subjects with adult subjects with Irritable Bowel Syndrome meeting the Rome III criteria. |
| Other GastroIntestinal (GI) Disorders | – | Diagnostic Test: Stool collectionA stool sample will be collected from adult subjects with adult subjects with gastrointestinal disorders other than IBD or IBS. |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult subjects and belonging to the target population, i.e. patients diagnosed with IBD, specifically CD, UC, or IC, patients diagnosed with IBS, and patients diagnosed with other gastrointestinal diseases, e.g. Celiac Disease, Diverticular Disease, Chronic Diarrhea and Recurrent Abdominal Pain (RAP).
Key inclusion criteria (5 listed)
- Subject is of either gender and ≥ 4 years of age.
- Subject is showing signs and symptoms of IBD and/or IBS.
- Diagnosis of IBD, IBS or other gastrointestinal disorder is performed by colonoscopy.
- Subject or authorized legal representative is willing and able to sign the IRB approved Informed Consent form or able to provide Informed Consent in accordance with 21 CFR 50 CFR 50 Subpart B.
- Subject is able to understand and follow study sample collection procedure.
Key exclusion criteria (6 listed)
- Subject has undergone a surgical resection or diversion procedure.
- Subject is currently taking NSAIDS (non-steroidal anti-inflammatory drugs, i.e. ibuprofen, Advil, Motrin, Naproxen, Aleve including regular dose and low dose aspirin) within 7 days of colonoscopy and sample collection.
- Subject who has taken immunomodulators or biologic therapies within the previous 6 months of colonoscopy and sample collection.
- Subject who is currently pregnant or lactating.
- Subject is unable or unwilling to follow informed consent.
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 |
|---|---|---|
| Stool collectionStool sample collected by a subject who have been diagnosed with IBD, IBS or other GI disorder. The stool sample is tested in a laboratory where fecal calprotectin levels are quantified. | Diagnostic test | Inflammatory Bowel Disease (IBD), Irritable Bowel Syndrome (IBS), Other GastroIntestinal (GI) Disorders |
Primary outcome
Calprotectin Stool Collection
Time frame: Through Study Completion, an average of 1 year
In vitro diagnostic (IVD) device performance
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 7 Feb 2019.
- Individual participant dataSharing planned: Undecided
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Open-label Single-arm Study to Assess the Efficacy of Mirikizumab in Patients With Inflammatory Strictures Due to CD
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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.
13 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 Diseases and Irritable Bowel Syndrome, run by DiaSorin Inc. at 13 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 5 inclusion and 6 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 7 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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?
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?
Calprotectin Stool Collection (time frame: Through Study Completion, an average of 1 year). 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 7 Feb 2019.