Crohn DiseaseOptiCalNCT03051204
OptiCal Study -Optimizing Fecal Calprotectin Monitoring: a Clinical Study Comparing CalproLab Against PhiCal and Evaluating Its Association With the Gut Microbiome
An observational study of Crohn Disease and Ulcerative Colitis, run by University of California, Los Angeles at 1 site in United States.
Trial summary
Study Aims: To analyze stool specimens to test and validate the CalproLab assay against the predicate PhiCal in order to determine performance characteristics. And to correlate Calpro levels to the gut microbiome composition. Read more about this study
- Who is it for?
- Ages 4 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Crohn Disease, Ulcerative Colitis, Irritable Bowel Syndrome
- How many people
- 175 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2017to 11 Dec 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Male and female subjects 4-65y years of age with diagnosed Crohn's disease and ulcerative colitis. (75) IBD patients - Ulcerative Colitis (UC) or Crohn's Disease (CD) (50) IBS patients (25) Celiac Disease Patients (25) Healthy Controls
Who may be able to join
- Male and female IBD patients should have had CD or UC for at least a period of six months*
- Male and female patients should have had Celiac disease for at least three months.
- Subjects willing and able to sign informed consent
- Subjects willing and able to provide stool sample using a home kit
- IBS patients will meet Rome Foundation criteria and received standard of care evaluations to exclude other diagnoses
- Healthy controls will consist of patients who do not have any IBD or IBS diagnosis and meet exclusion criteria for health in nearby table
Who cannot join
- Unwilling or unable to adhere to the protocol
- Unwilling or unable to adhere to the informed consent
- Age <4y or >65y
- Any of the following conditions by medical history:
- Individuals with intestinal cancer
- Individual taking anti-inflammatory drugs
Show all 10Show fewer
- Individuals receiving chemotherapy
- Individuals with a known intestinal infection
- Individuals with known upper gastrointestinal disease such as esophagitis or gastritis that might influence the test's ability to detect intestinal inflammatory disease.
- Individuals who are scheduled for endoscopy within 24 hours after providing the sample, or have undergone endoscopy during the 72 hours before providing the sample.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Center for Inflammatory Bowel Diseases
Los Angeles, California, 90095
About this study
Study Aims:
To analyze stool specimens to test and validate the CalproLab assay against the predicate PhiCal in order to determine performance characteristics.
And to correlate Calpro levels to the gut microbiome composition.
Read the detailed description
Fecal Calprotectin has become one of the most frequently used biomarkers in patients suffering from Inflammatory Bowel Diseases. Although its use for monitoring disease activity and therapeutic efficiency has previously been demonstrated, the test performance should further be optimized to improve clinical accuracy. The PhiCal™ test is a quantitative ELISA for measuring, in human stool, concentrations of fecal calprotectin, a neutrophilic protein that is a marker of mucosal inflammation. The PhiCal™ test can be used as an in vitro diagnostic to aid in the diagnosis of inflammatory bowel diseases (Crohn's disease and Ulcerative Colitis), and to differentiate IBD from irritable bowel syndrome. Recently, the CalproLab™ in vitro device has become available which provides a greater reporting range than PhiCal™. The OptiCal study aims to test and validate the CalproLab™ assay against the PhiCal™ assay and determine its performance characteristics.
Calprotectin is a valuable clinical marker for inflammation. Calprotectin belongs to a group of calcium- binding neutrophil-derived proteins. Calprotectin makes up 60% of the cytosolic proteins within the neutrophil. It is very resistant to bacterial degradation in the gut and is stable in stool for up to one week
at room temperature. Calprotectin is the noninvasive "test of choice" for quantifying the degree of GI inflammation and differentiating Irritable Bowel Syndrome (IBS) from Inflammatory Bowel Disease (IBD).
Inflammatory bowel disease (IBD) is considered to result from interplay between host and intestinal microbiota. Recently it was shown that the microbiota varied along a gradient of increasing intestinal inflammation (indicated by calprotectin levels), which was associated with reduced microbial richness, abundance of butyrate producers, and relative abundance of Gram-positive bacteria (especially Clostridium clusters IV and XIVa). A significant association between microbiota composition and inflammation was indicated by a set of bacterial groups predicting the calprotectin levels. So, intestinal microbiota may represent a potential biomarker for correlating the level of inflammation and therapeutic responses but this needs to be further validated.
- This study is a prospective case series during which patients with either Crohn's disease or ulcerative colitis, Celiac Disease, Irritable Bowel Syndrome and healthy controls (N=175) will be invited to participate.
- Participants will receive a home kit (with a plain white plastic cup for calprotectin sample collections) for stool sampling, which then will be returned and processed at Genova Diagnostics. All participants are required to complete a patient survey, which will be included in the collection kit.
- Participants will be recruited through the UCLA Division of Digestive Diseases.
- All patients will have confirmation of their diagnosis according to published clinical guidelines and standards of care using gold standard diagnostics (e.g. endoscopy)
- Stool specimens will be analyzed for fecal Calprotectin using both the CalproLab™ assay and the PhiCal™ assay. No blood draws or other testing will be performed.
- Patients will undergo a gut microbiome assessment utilizing the GI Effects™ 2200 Comprehensive Profile (Genova Diagnostics).
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative, Irritable Bowel Syndrome, Celiac Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Calprotectin
Concentration of calprotectin in stool sample
Measured: up to 2 weeks from consent/enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2017
- Study start28 Feb 2017
- Primary completion11 Dec 2018
- Study completion11 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Genova Diagnostics
- Responsible party
- Sponsor
- Investigators
- Daniel Hommes, MD, Principal investigator, UCLA IBD CENTER
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03051204
- Sponsor's protocol ID
- IRB#16-001499
- Acronym
- OptiCal
- Status last verified
- Sep 2023
- First submitted
- 9 Feb 2017
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All participants data will be de-identified by the research coordinator in standing with HIPAA regulations.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OptiCal Study -Optimizing Fecal Calprotectin Monitoring: a Clinical Study Comparing CalproLab Against PhiCal and Evaluating Its Association With the Gut Microbiome
- ClinicalTrials.gov ID
- NCT03051204
- Acronym / sponsor ID
- OptiCal / IRB#16-001499
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Genova Diagnostics
- Study start
- 28 Feb 2017 (actual)
- Primary completion
- 11 Dec 2018 (actual)
- Study completion
- 11 Dec 2018 (actual)
- First posted
- 13 Feb 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.
Study Aims:
To analyze stool specimens to test and validate the CalproLab assay against the predicate PhiCal in order to determine performance characteristics.
And to correlate Calpro levels to the gut microbiome composition.
Detailed description
Fecal Calprotectin has become one of the most frequently used biomarkers in patients suffering from Inflammatory Bowel Diseases. Although its use for monitoring disease activity and therapeutic efficiency has previously been demonstrated, the test performance should further be optimized to improve clinical accuracy. The PhiCal™ test is a quantitative ELISA for measuring, in human stool, concentrations of fecal calprotectin, a neutrophilic protein that is a marker of mucosal inflammation. The PhiCal™ test can be used as an in vitro diagnostic to aid in the diagnosis of inflammatory bowel diseases (Crohn's disease and Ulcerative Colitis), and to differentiate IBD from irritable bowel syndrome. Recently, the CalproLab™ in vitro device has become available which provides a greater reporting range than PhiCal™. The OptiCal study aims to test and validate the CalproLab™ assay against the PhiCal™ assay and determine its performance characteristics.
Calprotectin is a valuable clinical marker for inflammation. Calprotectin belongs to a group of calcium- binding neutrophil-derived proteins. Calprotectin makes up 60% of the cytosolic proteins within the neutrophil. It is very resistant to bacterial degradation in the gut and is stable in stool for up to one week
at room temperature. Calprotectin is the noninvasive "test of choice" for quantifying the degree of GI inflammation and differentiating Irritable Bowel Syndrome (IBS) from Inflammatory Bowel Disease (IBD).
Inflammatory bowel disease (IBD) is considered to result from interplay between host and intestinal microbiota. Recently it was shown that the microbiota varied along a gradient of increasing intestinal inflammation (indicated by calprotectin levels), which was associated with reduced microbial richness, abundance of butyrate producers, and relative abundance of Gram-positive bacteria (especially Clostridium clusters IV and XIVa). A significant association between microbiota composition and inflammation was indicated by a set of bacterial groups predicting the calprotectin levels. So, intestinal microbiota may represent a potential biomarker for correlating the level of inflammation and therapeutic responses but this needs to be further validated.
- This study is a prospective case series during which patients with either Crohn's disease or ulcerative colitis, Celiac Disease, Irritable Bowel Syndrome and healthy controls (N=175) will be invited to participate.
- Participants will receive a home kit (with a plain white plastic cup for calprotectin sample collections) for stool sampling, which then will be returned and processed at Genova Diagnostics. All participants are required to complete a patient survey, which will be included in the collection kit.
- Participants will be recruited through the UCLA Division of Digestive Diseases.
- All patients will have confirmation of their diagnosis according to published clinical guidelines and standards of care using gold standard diagnostics (e.g. endoscopy)
- Stool specimens will be analyzed for fecal Calprotectin using both the CalproLab™ assay and the PhiCal™ assay. No blood draws or other testing will be performed.
- Patients will undergo a gut microbiome assessment utilizing the GI Effects™ 2200 Comprehensive Profile (Genova Diagnostics).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 4 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Male and female subjects 4-65y years of age with diagnosed Crohn's disease and ulcerative colitis. (75) IBD patients - Ulcerative Colitis (UC) or Crohn's Disease (CD) (50) IBS patients (25) Celiac Disease Patients (25) Healthy Controls
Key inclusion criteria (6 listed)
- Male and female IBD patients should have had CD or UC for at least a period of six months*
- Male and female patients should have had Celiac disease for at least three months.
- Subjects willing and able to sign informed consent
- Subjects willing and able to provide stool sample using a home kit
- IBS patients will meet Rome Foundation criteria and received standard of care evaluations to exclude other diagnoses
Key exclusion criteria (10 listed)
- Unwilling or unable to adhere to the protocol
- Unwilling or unable to adhere to the informed consent
- Age <4y or >65y
- Any of the following conditions by medical history:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Calprotectin
Time frame: up to 2 weeks from consent/enrollment
Concentration of calprotectin in stool sample
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 22 Sep 2023.
- Individual participant dataSharing planned: No. All participants data will be de-identified by the research coordinator in standing with HIPAA regulations.
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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.
Daniel Hommes, MD principal investigator
UCLA IBD CENTER
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 Crohn Disease and Ulcerative Colitis, run by University of California, Los Angeles 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 6 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: finished, as of the sponsor's last update on 22 Sep 2023. 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?
Calprotectin (time frame: up to 2 weeks from consent/enrollment). 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 22 Sep 2023.