Pancreatic DiseasesNCT04391426
Analysis of Biliary Microbiota in Hepatobiliopancreatic Diseases Compared to Healthy People [MICROBILIO]
An observational study of Pancreatic Diseases and Microbiota, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The performance of the microbiota is observed in all clinical and pathological stages of carcinogenesis, since its development, diagnosis and treatment, including prognosis and survival. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pancreatic Diseases, Microbiota, Early Detection of Cancer
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- 3 Jun 2021to 16 Jan 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Tertiary care adult patients with hepatobiliopancreatic diseases compared to healthy people, that are living donors of liver transplant
Who may be able to join
- Endoscopic retrograde cholangiopancreatography (ERCP) candidates (case group)
- Patients over 18 years old complete
- Patients previously scheduled for ERCP
- Cannulation of the bile duct, via the transpapillary route, with the aid of a papillotome with an end kept sterile until contact with the papilla
- Liver transplant living-donor (control group)
- Patients over 18 years old up to 55 years
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- Previously selected patients with scheduled surgery
- BMI: 18 kg / m² to 28 kg / m²
- Blood typing identical to the recipient
- Absence of significant medical, psychiatric problems or previous abdominal surgery
- Normal laboratory tests: liver function tests, blood count, coagulogram, pregnancy test and serology for hepatitis B, C and HIV
- Normal imaging exams: CT of the abdomen and pelvis with liver volume (remaining volume - 30-40% of the total liver volume), MRI with cholangioresonance
Who cannot join
- ERCP candidates (case group)
- Use of antibiotics during ERCP or in the last 2 months prior to the procedure
- Emergency ERCP
- Pregnancy
- Uncorrected coagulopathy
- Liver transplant living-donor (control group)
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- Use of antibiotics in the last 2 months prior to the procedure
- Pregnancy
- Uncorrected coagulopathy
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
University of Sao Paulo School of Medicine
São Paulo, 05403-000
Alberto Meyer, +55(11)2661-3323, alberto.meyer@usp.br
About this study
The performance of the microbiota is observed in all clinical and pathological stages of carcinogenesis, since its development, diagnosis and treatment, including prognosis and survival. However, it was found that there is a scarcity of studies on biliary microbiota and its relationship with hepatobiliopancreatic diseases. Therefore, further investigation is necessary, since reaching the biliary microbiota may suggest ways for studies of biomarkers, diagnoses, tests and therapies in hepatobiliopancreatic diseases. For this, bile samples will be collected in cases and controls patients to characterize the microbiota and its variations according to the disease.
- Conditions
- Pancreatic Diseases, Microbiota, Early Detection of Cancer, Dysbiosis, Biliary Tract Diseases
- Medical subject headings
- Pancreatic Diseases, Dysbiosis, Biliary Tract Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients who will undergo ERCP (case group) | Not described | |
| Living liver transplantation donors (control group) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composition of the biliary microbiota
In this study, the investigator's objective will be to characterize the specific composition of the biliary microbiota in patients with hepatobiliopancreatic diseases in comparison with healthy people using 16S ribosomal RNA (rRNA) pyrosequencing methods.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2020
- Study start3 Jun 2021
- Primary completion1 Jan 2023 (estimated)
- Study completion16 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic DiseasesStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alberto Meyer, MD PhD FACS, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04391426
- Sponsor's protocol ID
- 29547920.9.0000.0068
- Status last verified
- Sep 2021
- First submitted
- 25 Apr 2020
- Last updated
- 28 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nascimento FSD, Suzuki MO, Taba JV, de Mattos VC, Pipek LZ, D'Albuquerque EMC, Iuamoto L, Meyer A, Andraus W, Pinho JRR, de Moura EGH, Setubal JC, Carneiro-D'Albuquerque LA. Analysis of biliary MICRObiota in hepatoBILIOpancreatic diseases compared to healthy people [MICROBILIO]: Study protocol. PLoS One. 2020 Nov 19;15(11):e0242553. doi: 10.1371/journal.pone.0242553. eCollection 2020.
PubMed 33211762
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Biliary Microbiota in Hepatobiliopancreatic Diseases Compared to Healthy People [MICROBILIO]
- ClinicalTrials.gov ID
- NCT04391426
- Acronym / sponsor ID
- 29547920.9.0000.0068
- Conditions
- Pancreatic Diseases, Microbiota, Early Detection of Cancer, Dysbiosis, Biliary Tract Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 3 Jun 2021 (actual)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 16 Jan 2024 (estimated)
- First posted
- 18 May 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 performance of the microbiota is observed in all clinical and pathological stages of carcinogenesis, since its development, diagnosis and treatment, including prognosis and survival. However, it was found that there is a scarcity of studies on biliary microbiota and its relationship with hepatobiliopancreatic diseases. Therefore, further investigation is necessary, since reaching the biliary microbiota may suggest ways for studies of biomarkers, diagnoses, tests and therapies in hepatobiliopancreatic diseases. For this, bile samples will be collected in cases and controls patients to characterize the microbiota and its variations according to the disease.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients who will undergo ERCP (case group) | – | – |
| Living liver transplantation donors (control group) | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Tertiary care adult patients with hepatobiliopancreatic diseases compared to healthy people, that are living donors of liver transplant
Key inclusion criteria (12 listed)
- Endoscopic retrograde cholangiopancreatography (ERCP) candidates (case group)
- Patients over 18 years old complete
- Patients previously scheduled for ERCP
- Cannulation of the bile duct, via the transpapillary route, with the aid of a papillotome with an end kept sterile until contact with the papilla
- Liver transplant living-donor (control group)
Key exclusion criteria (9 listed)
- ERCP candidates (case group)
- Liver transplant living-donor (control group)
- Use of antibiotics in the last 2 months prior to the procedure
- Pregnancy
- Uncorrected coagulopathy
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
Composition of the biliary microbiota
Time frame: 2 years
In this study, the investigator's objective will be to characterize the specific composition of the biliary microbiota in patients with hepatobiliopancreatic diseases in comparison with healthy people using 16S ribosomal RNA (rRNA) pyrosequencing methods.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Derived from this study: PubMed 33211762Nascimento FSD, Suzuki MO, Taba JV, de Mattos VC, Pipek LZ, D'Albuquerque EMC, Iuamoto L, Meyer A, Andraus W, Pinho JRR, de Moura EGH, Setubal JC, Carneiro-D'Albuquerque LA. Analysis of biliary MICRObiota in hepatoBILIOpancreatic diseases compared to healthy people [MICROBILIO]: Study protocol. PLoS One. 2020 Nov 19;15(11):e0242553. doi: 10.1371/journal.pone.0242553. eCollection 2020.
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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.
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 Pancreatic Diseases and Microbiota, run by University of Sao Paulo at 1 site in Brazil.
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 9 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: status not confirmed, as of the sponsor's last update on 28 Sep 2021. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alberto Meyer, PhD (+55(11)2661-3323, alberto.meyer@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composition of the biliary microbiota (time frame: 2 years). 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 NCT04391426, which also lists 1 linked publication.
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 28 Sep 2021.