Exocrine Pancreatic InsufficiencyNCT04548778
BÜHLMANN FPELA in the Diagnosis of Exocrine Pancreatic Insufficiency
An observational study of Exocrine Pancreatic Insufficiency, run by Bühlmann Laboratories AG at 1 site in Germany.
Trial summary
The study shall determine the clinical performance of the BÜHLMANN fecal pancreatic elastase (fPELA) assays in the diagnosis of exocrine pancreatic insufficiency (PEI). This is a observational and cross-sectional performance study. Specimens and clinical data are collected by a single study site. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Exocrine Pancreatic Insufficiency
- What is being tested?
- BÜHLMANN fPELA assay
- How many people
- 201 participants
- Where
- 1 siteGermany
- Study dates
- 1 Nov 2020to 21 Sep 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Included are subjects for which pancreatic elastase testing was indicated due to a suspected exocrine pancreatic insufficiency and which were at least 18 years of age. Following patient groups show an increased risk for developing an exocrine insufficiency: chronic pancreatitis, cystic fibrosis, diabetes, pancreatic resection. Eligible study subjects provide one stool sample which is forwarded to the study site within three days.
Who may be able to join
- suspected exocrine pancreatic insufficiency
- at least 18 years of age.
Who cannot join
- diarrhea (stool water content ≥ 75%) at the time of sample collection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of BÜHLMANN Fecal Pancreatic Elastase (fPELA) Tests in the Diagnosis of Exocrine Pancreatic Insufficiency (PEI)
The study shall determine the clinical performance of the BÜHLMANN fecal pancreatic elastase (fPELA) assays in the diagnosis of exocrine pancreatic insufficiency (PEI).
This is a observational and cross-sectional performance study. Specimens and clinical data are collected by a single study site.
Included are subjects for which pancreatic elastase testing was indicated due to a suspected exocrine pancreatic insufficiency and which were at least 18 years of age. Subjects which suffered from diarrhea (stool water content ≥ 75%) at the time of sample collection are excluded from the study.
- Conditions
- Exocrine Pancreatic Insufficiency
- Being tested
- BÜHLMANN fPELA assay
- Medical subject headings
- Exocrine Pancreatic Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BÜHLMANN fPELA assayDiagnostic test
BÜHLMANN fPELA assays are immunoassays for the quantitative determination of fecal pancreatic elastase in human stool samples.
| Study group | Role | What they receive |
|---|---|---|
| exocrine pancreatic insufficiency (PEI) | Established diagnosis of PEI based on a routine clinical diagnostic work-up including a treat-to-diagnose approach using Pancreatic Enzyme Replacement Therapy (PERT). Receives: Diagnostic Test: BÜHLMANN fPELA assay | |
| no exocrine pancreatic insufficiency (no PEI) | No evidence of PEI according to routine clinical diagnostic work-up including a treat-to-diagnose approach using Pancreatic Enzyme Replacement Therapy (PERT). Receives: Diagnostic Test: BÜHLMANN fPELA assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Performance of BÜHLMANN fPELA assays in the diagnosis of PEI
Diagnostic sensitivity and specificity of BÜHLMANN fPELA assays
Measured: December 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start1 Nov 2020
- Primary completion21 Sep 2024
- Study completion21 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exocrine Pancreatic InsufficiencyStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bühlmann Laboratories AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jonas Rosendahl, MD, Principal investigator, Universitätsklinikum der Martin-Luther-Universität Halle-Wittenberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04548778
- Sponsor's protocol ID
- fPELA_ClinPerform2020
- Status last verified
- Aug 2024
- First submitted
- 8 Sep 2020
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of BÜHLMANN Fecal Pancreatic Elastase (fPELA) Tests in the Diagnosis of Exocrine Pancreatic Insufficiency (PEI)
- ClinicalTrials.gov ID
- NCT04548778
- Acronym / sponsor ID
- fPELA_ClinPerform2020
- Conditions
- Exocrine Pancreatic Insufficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Bühlmann Laboratories AGIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 21 Sep 2024 (actual)
- Study completion
- 21 Sep 2024 (actual)
- First posted
- 16 Sep 2020 (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 study shall determine the clinical performance of the BÜHLMANN fecal pancreatic elastase (fPELA) assays in the diagnosis of exocrine pancreatic insufficiency (PEI).
This is a observational and cross-sectional performance study. Specimens and clinical data are collected by a single study site.
Included are subjects for which pancreatic elastase testing was indicated due to a suspected exocrine pancreatic insufficiency and which were at least 18 years of age. Subjects which suffered from diarrhea (stool water content ≥ 75%) at the time of sample collection are excluded from the study.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exocrine pancreatic insufficiency (PEI) | – | Diagnostic Test: BÜHLMANN fPELA assayEstablished diagnosis of PEI based on a routine clinical diagnostic work-up including a treat-to-diagnose approach using Pancreatic Enzyme Replacement Therapy (PERT). |
| no exocrine pancreatic insufficiency (no PEI) | – | Diagnostic Test: BÜHLMANN fPELA assayNo evidence of PEI according to routine clinical diagnostic work-up including a treat-to-diagnose approach using Pancreatic Enzyme Replacement Therapy (PERT). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Included are subjects for which pancreatic elastase testing was indicated due to a suspected exocrine pancreatic insufficiency and which were at least 18 years of age. Following patient groups show an increased risk for developing an exocrine insufficiency: chronic pancreatitis, cystic fibrosis, diabetes, pancreatic resection. Eligible study subjects provide one stool sample which is forwarded to the study site within three days.
Key inclusion criteria (2 listed)
- suspected exocrine pancreatic insufficiency
- at least 18 years of age.
Key exclusion criteria (1 listed)
- diarrhea (stool water content ≥ 75%) at the time of sample collection
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 |
|---|---|---|
| BÜHLMANN fPELA assayBÜHLMANN fPELA assays are immunoassays for the quantitative determination of fecal pancreatic elastase in human stool samples. | Diagnostic test | exocrine pancreatic insufficiency (PEI), no exocrine pancreatic insufficiency (no PEI) |
Primary outcome
Clinical Performance of BÜHLMANN fPELA assays in the diagnosis of PEI
Time frame: December 2021
Diagnostic sensitivity and specificity of BÜHLMANN fPELA assays
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 16 Dec 2024.
Related trials for Exocrine Pancreatic Insufficiency
RecruitingObservational study
Cancer in Inherited Bone Marrow Failure Syndromes
Diamond Blackfan Anemia, Dyskeratosis Congenita
RecruitingPhase 2
Phase 2 Study to Assess the Safety and Efficacy of ANG003
Exocrine Pancreatic Insufficiency (EPI), Cystic Fibrosis (CF)
RecruitingObservational study
Determine the Prevalence of Exocrine Pancreatic Insufficiency (EPI) in Pediatric and Adult Participants With Alagille Syndrome After Liver Transplantation
Exocrine Pancreatic Insuficiency
RecruitingPhase 3
Comparative Study to Evaluate Microbial Versus Porcine Pancreatic Enzyme Therapy in Chronic Pancreatitis
Pancreatitis, Chronic, Exocrine Pancreatic Insufficiency (EPI)
Active, not recruitingPhase 4
A Study Of Effect Of Secretin For In Injection (Chirostim) On Pancreatic Fluid Composition In Healthy Subjects
Exocrine Pancreatic Insufficiency, Chronic Pancreatitis
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.
Jonas Rosendahl, MD principal investigator
Universitätsklinikum der Martin-Luther-Universität Halle-Wittenberg
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 Exocrine Pancreatic Insufficiency, run by Bühlmann Laboratories AG at 1 site in Germany.
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 2 inclusion and 1 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 16 Dec 2024. 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 Germany. 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 Performance of BÜHLMANN fPELA assays in the diagnosis of PEI (time frame: December 2021). 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 16 Dec 2024.