Inflammatory Bowel DiseaseNCT02351635
BÜHLMANN fCAL™ ELISA - Aid in Differentiation of IBD From IBS
An observational study of Inflammatory Bowel Disease and Irritable Bowel Syndrome, run by Bühlmann Laboratories AG at 7 sites in United States.
Trial summary
The purpose of this study is to confirm the sensitivity and specificity of the BÜHLMANN fCAL™ ELISA as an aid in diagnosis to differentiate between Inflammatory Bowel Disease (IBD; Crohn's Disease (CD), Ulcerative Colitis (UC), or indeterminate colitis) and Irritable Bowel Syndrome (IBS). 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, Irritable Bowel Syndrome
- What is being tested?
- fecal calprotectin level
- How many people
- 478 participants
- Where
- 7 sitesUnited States
- Study dates
- Jan 2015to Apr 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 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 100 adult subjects with Inflammatory Bowel Disease or Irritable Bowel Syndrome each have provided a stool sample. In addition, 50 pediatric subjects, age 2 years to 21 years, 25 subjects in each diagnostic group (IBD, IBS) will be enrolled. Recruitment of 120 normal subjects who will provide samples.
Who may be able to join
- Adults or pediatric patients evaluated by a gastroenterological service for investigation of possible inflammatory intestinal disease or IBS. Patients are referred for sub-specialty evaluation of symptoms such as abdominal pain, diarrhea, altered appetite, weight loss, or anemia.
- IBD: Eligible subjects will be analyzed as patients with IBD after a confirmed diagnosis of Inflammatory Bowel Disease (CD, UC, or Indeterminate Colitis), based on endoscopy and confirmed by histology of biopsies taken during endoscopy.
- IBS: Eligible candidate subjects can also include patients who are self-referred with the relevant constellation of complaints. Eligible subjects will be enrolled after having a diagnosis of IBS based on the Rome III criteria confirmed by negative endoscopy including the colon and terminal ileum.
- other GI Disorders: Eligible subjects will be enrolled after having a diagnosis of a gastrointestinal disorder other than IBD or IBS, confirmed by endoscopy results and other appropriate diagnostic studies.
- Healthy Controls: Adults (≥22) with no abdominal complaints and no history of IBS, IBD or other chronic intestinal disorder, confirmed by medical history and physical examination at enrolment.
- Individuals of either gender, ≥22 years of age (adult samples) or 2 to -21 years of age (pediatric samples).
- IBD patients whose diagnostic endoscopy occurred within the previous month.
- Individuals able to understand the study and the tasks required, and who sign the Informed Consent Form (adult subjects; ICF) or whose parent/guardian provides consent (ICF) and, if age 7-to-18 years of age, who provide assent (pediatric subjects).
Who cannot join
- Individuals unable or unwilling to provide a stool specimen.
- Individuals with known intestinal cancer, intestinal infection, upper gastrointestinal disease
- Individuals receiving chemotherapy or systemic immunosuppressive drugs.
- Individuals who have taken, within the previous 2 weeks, protein pump inhibitors or H2-receptor antagonists.
- Individuals with previously diagnosed Inflammatory Bowel Disease managed with immunomodulators, 5-ASA (5-aminosalicylic acid) or biologic therapies or who have undergone a surgical resection or diversion procedure.
- Individuals who have taken NSAIDs (nonsteroidal anti-inflammatory drugs), including aspirin, on 7 or more days during the 2 weeks before providing the sample.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Beth israel Deaconess Medical Center
Boston, Massachusetts, 02215
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, 23320
Gastroenterology Assocaites of Central Georgia
Macon, Georgia, 31201
Great Lakes Gastroenterology Research, LLC.
Mentor, Ohio, 44060
Gastro Health
Miami, Florida, 33173
Stanford Center for Clinical & Translational Research & Education
Palo Alto, California, 94304
Carle Foundation, Center for Digestive and Liver Disease
Urbana, Illinois, 61801
About this study
Official title: Clinical Study of the BÜHLMANN fCAL™ ELISA as an Aid in the Differentiation of Inflammatory Bowel Disease From Irritable Bowel Syndrome
The purpose of this study is to confirm the sensitivity and specificity of the BÜHLMANN fCAL™ ELISA as an aid in diagnosis to differentiate between Inflammatory Bowel Disease (IBD; Crohn's Disease (CD), Ulcerative Colitis (UC), or indeterminate colitis) and Irritable Bowel Syndrome (IBS).
To estimate the predictive value of a positive test (positive predictive value (PPV)) and the predictive value of a negative test (Negative Predictive Value (NPV)) using the proposed test outcomes for BÜHLMANN Calprotectin Test results when used in patients referred for diagnostic evaluation with signs and symptoms suggestive of either IBS or IBD.
Read more
To confirm the inter-laboratory consistency of test results for the BÜHLMANN fCAL™ ELISA.
To provide exploratory observations of test results in patients between the age of 2 and 21 years.
To provide a sample set from normal subjects with no symptoms or signs of gastrointestinal disease for use in Expected Value Testing.
- Being tested
- fecal calprotectin level
- Keywords
- Calprotectin, Diagnosis
- Medical subject headings
- Inflammatory Bowel Diseases, Irritable Bowel Syndrome, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fecal calprotectin levelOther
Stool sample collected by the subject, sent study laboratories where fecal calprotectin levels are quantified.
| Study group | Role | What they receive |
|---|---|---|
| IBD | Adult subjects with inflammatory bowel disease, confirmed by endoscopy and histologic support. Fecal calprotectin Level. Receives: Other: fecal calprotectin level | |
| IBS | Adult subjects with Irritable Bowel Syndrome meeting the Rome III criteria. Fecal calprotectin Level. Receives: Other: fecal calprotectin level | |
| other GI disorders | Adult subjects with gastrointestinal disorders other than IBD or IBS. Fecal calprotectin Level. Receives: Other: fecal calprotectin level | |
| pediatric | Pediatric patients (2-21 y) diagnosed with IBD, IBS, or other gastrointestinal disorders. Fecal calprotectin Level. Receives: Other: fecal calprotectin level | |
| healthy controls | Normal adult subjects with no abdominal complaints. Fecal calprotectin Level. Receives: Other: fecal calprotectin level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical value of in vitro diagnostic (IVD) device
Sensitivity, specificity; Positive predictive value (PPV), negative predictive value (NPV) and likelihood ratios (positive and negative)
Measured: End of Study
Secondary outcomes (2)
normal Calprotectin values
Calprotectin values from normal healthy donors will be calculated
Measured: End of Study
Clinical value of IVD device in pediatric population
Results of the pediatric population will be used as preliminary and exploratory evidence that calprotectin test can be used in this population
Measured: End of Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionMar 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseaseStudies 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
- 478 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bühlmann Laboratories AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ICON Clinical Research
- Responsible party
- Sponsor
- Investigators
- Allison Gorman, Study director, ICON Clincal Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02351635
- Sponsor's protocol ID
- ALP Cal01
- Status last verified
- Jan 2019
- First submitted
- 27 Jan 2015
- Last updated
- 18 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Manz M, Burri E, Rothen C, Tchanguizi N, Niederberger C, Rossi L, Beglinger C, Lehmann FS. Value of fecal calprotectin in the evaluation of patients with abdominal discomfort: an observational study. BMC Gastroenterol. 2012 Jan 10;12:5. doi: 10.1186/1471-230X-12-5.
PubMed 22233279Occhipinti K, Smith JW. Irritable bowel syndrome: a review and update. Clin Colon Rectal Surg. 2012 Mar;25(1):46-52. doi: 10.1055/s-0032-1301759.
PubMed 23449495Kappelman MD, Moore KR, Allen JK, Cook SF. Recent trends in the prevalence of Crohn's disease and ulcerative colitis in a commercially insured US population. Dig Dis Sci. 2013 Feb;58(2):519-25. doi: 10.1007/s10620-012-2371-5. Epub 2012 Aug 29.
PubMed 22926499Burri E, Beglinger C. Faecal calprotectin -- a useful tool in the management of inflammatory bowel disease. Swiss Med Wkly. 2012 Apr 5;142:w13557. doi: 10.4414/smw.2012.13557. eCollection 2012.
PubMed 22481443van Rheenen PF, Van de Vijver E, Fidler V. Faecal calprotectin for screening of patients with suspected inflammatory bowel disease: diagnostic meta-analysis. BMJ. 2010 Jul 15;341:c3369. doi: 10.1136/bmj.c3369.
PubMed 20634346
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of the BÜHLMANN fCAL™ ELISA as an Aid in the Differentiation of Inflammatory Bowel Disease From Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT02351635
- Acronym / sponsor ID
- ALP Cal01
- Keywords
- Calprotectin, Diagnosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 478 participants (actual)
- Lead sponsor
- Bühlmann Laboratories AGIndustry (pharma, biotech, devices)
- Collaborators
- ICON Clinical Research
- Study start
- Jan 2015
- Primary completion
- Mar 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 30 Jan 2015 (estimated)
- 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 purpose of this study is to confirm the sensitivity and specificity of the BÜHLMANN fCAL™ ELISA as an aid in diagnosis to differentiate between Inflammatory Bowel Disease (IBD; Crohn's Disease (CD), Ulcerative Colitis (UC), or indeterminate colitis) and Irritable Bowel Syndrome (IBS).
To estimate the predictive value of a positive test (positive predictive value (PPV)) and the predictive value of a negative test (Negative Predictive Value (NPV)) using the proposed test outcomes for BÜHLMANN Calprotectin Test results when used in patients referred for diagnostic evaluation with signs and symptoms suggestive of either IBS or IBD.
To confirm the inter-laboratory consistency of test results for the BÜHLMANN fCAL™ ELISA.
To provide exploratory observations of test results in patients between the age of 2 and 21 years.
To provide a sample set from normal subjects with no symptoms or signs of gastrointestinal disease for use in Expected Value Testing.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| IBD | – | Other: fecal calprotectin levelAdult subjects with inflammatory bowel disease, confirmed by endoscopy and histologic support. Fecal calprotectin Level. |
| IBS | – | Other: fecal calprotectin levelAdult subjects with Irritable Bowel Syndrome meeting the Rome III criteria. Fecal calprotectin Level. |
| other GI disorders | – | Other: fecal calprotectin levelAdult subjects with gastrointestinal disorders other than IBD or IBS. Fecal calprotectin Level. |
| pediatric | – | Other: fecal calprotectin levelPediatric patients (2-21 y) diagnosed with IBD, IBS, or other gastrointestinal disorders. Fecal calprotectin Level. |
| healthy controls | – | Other: fecal calprotectin levelNormal adult subjects with no abdominal complaints. Fecal calprotectin Level. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 100 adult subjects with Inflammatory Bowel Disease or Irritable Bowel Syndrome each have provided a stool sample. In addition, 50 pediatric subjects, age 2 years to 21 years, 25 subjects in each diagnostic group (IBD, IBS) will be enrolled. Recruitment of 120 normal subjects who will provide samples.
Key inclusion criteria (8 listed)
- Adults or pediatric patients evaluated by a gastroenterological service for investigation of possible inflammatory intestinal disease or IBS. Patients are referred for sub-specialty evaluation of symptoms such as abdominal pain, diarrhea, altered appetite, weight loss, or anemia.
- Individuals of either gender, ≥22 years of age (adult samples) or 2 to -21 years of age (pediatric samples).
- IBD patients whose diagnostic endoscopy occurred within the previous month.
- Individuals able to understand the study and the tasks required, and who sign the Informed Consent Form (adult subjects; ICF) or whose parent/guardian provides consent (ICF) and, if age 7-to-18 years of age, who provide assent (pediatric subjects).
Key exclusion criteria (6 listed)
- Individuals unable or unwilling to provide a stool specimen.
- Individuals with known intestinal cancer, intestinal infection, upper gastrointestinal disease
- Individuals receiving chemotherapy or systemic immunosuppressive drugs.
- Individuals who have taken, within the previous 2 weeks, protein pump inhibitors or H2-receptor antagonists.
- Individuals with previously diagnosed Inflammatory Bowel Disease managed with immunomodulators, 5-ASA (5-aminosalicylic acid) or biologic therapies or who have undergone a 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 |
|---|---|---|
| fecal calprotectin levelStool sample collected by the subject, sent study laboratories where fecal calprotectin levels are quantified. | Other | IBD, IBS, healthy controls, other GI disorders, pediatric |
Primary outcome
Clinical value of in vitro diagnostic (IVD) device
Time frame: End of Study
Sensitivity, specificity; Positive predictive value (PPV), negative predictive value (NPV) and likelihood ratios (positive and negative)
2 secondary outcomes
normal Calprotectin values
Time frame: End of Study
Clinical value of IVD device in pediatric population
Time frame: End of Study
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 18 Jan 2019.
- Background: PubMed 22233279Manz M, Burri E, Rothen C, Tchanguizi N, Niederberger C, Rossi L, Beglinger C, Lehmann FS. Value of fecal calprotectin in the evaluation of patients with abdominal discomfort: an observational study. BMC Gastroenterol. 2012 Jan 10;12:5. doi: 10.1186/1471-230X-12-5.
- Background: PubMed 23449495Occhipinti K, Smith JW. Irritable bowel syndrome: a review and update. Clin Colon Rectal Surg. 2012 Mar;25(1):46-52. doi: 10.1055/s-0032-1301759.
- Background: PubMed 22926499Kappelman MD, Moore KR, Allen JK, Cook SF. Recent trends in the prevalence of Crohn's disease and ulcerative colitis in a commercially insured US population. Dig Dis Sci. 2013 Feb;58(2):519-25. doi: 10.1007/s10620-012-2371-5. Epub 2012 Aug 29.
- Background: PubMed 22481443Burri E, Beglinger C. Faecal calprotectin -- a useful tool in the management of inflammatory bowel disease. Swiss Med Wkly. 2012 Apr 5;142:w13557. doi: 10.4414/smw.2012.13557. eCollection 2012.
- Background: PubMed 20634346van Rheenen PF, Van de Vijver E, Fidler V. Faecal calprotectin for screening of patients with suspected inflammatory bowel disease: diagnostic meta-analysis. BMJ. 2010 Jul 15;341:c3369. doi: 10.1136/bmj.c3369.
- 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.
Allison Gorman study director
ICON Clincal Research
7 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 and Irritable Bowel Syndrome, run by Bühlmann Laboratories AG at 7 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 8 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 18 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
Clinical value of in vitro diagnostic (IVD) device (time frame: End of Study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02351635, which also lists 5 linked publications.
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 18 Jan 2019.