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Jaundice, ObstructiveMicrobileNCT06115564

Microbiological Assessment of Bile in Patients Undergone to Endoscopic Retrograde Cholangiography (ERCP): the "Microbile Registry"

An observational study of Jaundice, Obstructive and Jaundice; Malignant, run by Azienda Unità Sanitaria Locale della Romagna at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The study is a prospective evaluation of the microbial assessment in patients undergoing to ERC with naive papilla; the population includes all the indication to biliary drainage. Read more about this study

Who is it for?
Ages 18 years and older
How many people
200 participants
Where
1 siteItaly
Study dates
1 Jul 2022to 31 Dec 2023
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: Any benignant or malignant ERC indication in naive papilla

Main inclusion criteria for patient enrollment were: ability to provide an informed consent; age >/=18 years; any benignant or malignant ERCP indication.

All subjects were excluded from the study:

  • Patients who have already undergone endoscopic sphincterotomy
  • Patients unable to express informed consent
  • Pregnant or breastfeeding women
  • Patients with anatomical post-surgical alterations of the upper gastrointestinal (GI) tract

Trial locations and contacts

1 site in 1 country.

Carlo Fabbri, MD contact

+39 3389353104

carlo.fabbri@auslromagna.it

Italy1 site, 1 recruiting

  • Ospedale Morgagni-Pierantoni

    Forlì, Forlì-Cesena

    Carlo Fabbri, MD, + 39 3389353104, carlo.fabbri@auslromagna.it

    Recruiting

Other trials in Italy

About this study

The study is a prospective evaluation of the microbial assessment in patients undergoing to ERC with naive papilla; the population includes all the indication to biliary drainage.

Medical subject headings
Jaundice, Obstructive, Jaundice, Choledocholithiasis, Gallbladder Diseases

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Microbial assessment in patients undergoing to ERC with naive papilla

    Coltural assessment of the bile samples obtained pre- and post-sphincterotomy during ERC in naive papilla.

    Measured: July 2022 to 2023

Secondary outcomes (5)

  1. MDR and sentinel germs detection

    Determine the presence and the prevalence of MDR organisms and sentinel germs in bile.

    Measured: July 2022 to 2023

  2. differences in the microbial community before and after sphincterotomy.

    Evaluation of differences in the microbial community before and after sphincterotomy.

    Measured: July 2022 to 2023

  3. Identify possible correlations between pre sphincterotomy positive biliary cultures, polymicrobial population and MDR organisms with several clinical features and with laboratory signs of acute cholangitis.

    Identify possible correlations between pre sphincterotomy positive biliary cultures, polymicrobial population and MDR organisms with several clinical features and with laboratory signs of acute cholangitis.

    Measured: July 2022 to 2023

  4. Identify potential differences in the pre sphincterotomy biliary microbial community depending on type of jaundice (benign or malignant).

    Identify potential differences in the pre sphincterotomy biliary microbial community depending on type of jaundice (benign or malignant).

    Measured: July 2022 to 2023

  5. Check the presence of a possible association between specific biliary bacterial strains and definite pancreaticobiliary disorders.

    Check the presence of a possible association between specific biliary bacterial strains and definite pancreaticobiliary disorders.

    Measured: July 2022 to 2023

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Nov 2023
  2. Study start1 Jul 2022
  3. Primary completion1 Dec 2023 (estimated)
  4. Study completion31 Dec 2023 (estimated)

Resources

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
Prospective
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06115564
Sponsor's protocol ID
4549/2022
Acronym
Microbile
Status last verified
Oct 2023
First submitted
30 Oct 2023
Last updated
3 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Nicoletti A, Ponziani FR, Nardella E, Ianiro G, Gasbarrini A, Zileri Dal Verme L. Biliary tract microbiota: a new kid on the block of liver diseases? Eur Rev Med Pharmacol Sci. 2020 Mar;24(5):2750-2775. doi: 10.26355/eurrev_202003_20548.

    PubMed 32196626

  • Molinero N, Ruiz L, Milani C, Gutierrez-Diaz I, Sanchez B, Mangifesta M, Segura J, Cambero I, Campelo AB, Garcia-Bernardo CM, Cabrera A, Rodriguez JI, Gonzalez S, Rodriguez JM, Ventura M, Delgado S, Margolles A. The human gallbladder microbiome is related to the physiological state and the biliary metabolic profile. Microbiome. 2019 Jul 4;7(1):100. doi: 10.1186/s40168-019-0712-8.

    PubMed 31272480

  • Miura F, Okamoto K, Takada T, Strasberg SM, Asbun HJ, Pitt HA, Gomi H, Solomkin JS, Schlossberg D, Han HS, Kim MH, Hwang TL, Chen MF, Huang WS, Kiriyama S, Itoi T, Garden OJ, Liau KH, Horiguchi A, Liu KH, Su CH, Gouma DJ, Belli G, Dervenis C, Jagannath P, Chan ACW, Lau WY, Endo I, Suzuki K, Yoon YS, de Santibanes E, Gimenez ME, Jonas E, Singh H, Honda G, Asai K, Mori Y, Wada K, Higuchi R, Watanabe M, Rikiyama T, Sata N, Kano N, Umezawa A, Mukai S, Tokumura H, Hata J, Kozaka K, Iwashita Y, Hibi T, Yokoe M, Kimura T, Kitano S, Inomata M, Hirata K, Sumiyama Y, Inui K, Yamamoto M. Tokyo Guidelines 2018: initial management of acute biliary infection and flowchart for acute cholangitis. J Hepatobiliary Pancreat Sci. 2018 Jan;25(1):31-40. doi: 10.1002/jhbp.509. Epub 2018 Jan 8.

    PubMed 28941329

  • Reiter FP, Obermeier W, Jung J, Denk G, Mahajan UM, De Toni EN, Schirra J, Mayerle J, Schulz C. Prevalence, Resistance Rates, and Risk Factors of Pathogens in Routine Bile Cultures Obtained during Endoscopic Retrograde Cholangiography. Dig Dis. 2021;39(1):42-51. doi: 10.1159/000509289. Epub 2020 Jun 10.

    PubMed 32521535

  • Chandra S, Klair JS, Soota K, Livorsi DJ, Johlin FC. Endoscopic Retrograde Cholangio-Pancreatography-Obtained Bile Culture Can Guide Antibiotic Therapy in Acute Cholangitis. Dig Dis. 2019;37(2):155-160. doi: 10.1159/000493579. Epub 2018 Oct 3.

    PubMed 30282078

  • Ye F, Shen H, Li Z, Meng F, Li L, Yang J, Chen Y, Bo X, Zhang X, Ni M. Influence of the Biliary System on Biliary Bacteria Revealed by Bacterial Communities of the Human Biliary and Upper Digestive Tracts. PLoS One. 2016 Mar 1;11(3):e0150519. doi: 10.1371/journal.pone.0150519. eCollection 2016.

    PubMed 26930491

  • Gomi H, Takada T, Hwang TL, Akazawa K, Mori R, Endo I, Miura F, Kiriyama S, Matsunaga N, Itoi T, Yokoe M, Chen MF, Jan YY, Ker CG, Wang HP, Wada K, Yamaue H, Miyazaki M, Yamamoto M. Updated comprehensive epidemiology, microbiology, and outcomes among patients with acute cholangitis. J Hepatobiliary Pancreat Sci. 2017 Jun;24(6):310-318. doi: 10.1002/jhbp.452. Epub 2017 May 26.

    PubMed 28371094

Questions about this trial

What is this clinical trial studying?

An observational study of Jaundice, Obstructive and Jaundice; Malignant, run by Azienda Unità Sanitaria Locale della Romagna at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 3 Nov 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 Italy. 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 Carlo Fabbri, MD (+39 3389353104, carlo.fabbri@auslromagna.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Microbial assessment in patients undergoing to ERC with naive papilla (time frame: July 2022 to 2023). 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 NCT06115564, which also lists 7 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 3 Nov 2023.

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