Ascitic Fluid, MicrobiotaNCT02813590
Ascitic Fluid Microbiome in Liver Cirrhosis
An observational study of Ascitic Fluid, Microbiota and Microbiota, run by Medical University of Graz at 1 site in Austria.
Trial summary
Ascitic fluid microbiome is going to be investigated in this study by using internal transcripted spacer (ITS) and 16S ribosomal RNA (rRNA) polymerase chain reaction (PCR) and sequencing as conventional culture methods are lacking sensitivity regarding diagnosis of spontaneous bacterial peritonitis (SBP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ascitic Fluid, Microbiota, Microbiota, Sequence Analysis
- What is being tested?
- Ascitic fluid puncture, Skin swaps from puncture side and Stool samples
- How many people
- 0 participants
- Where
- 1 siteAustria
- Study dates
- Jun 2016to Sep 2017
- 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: Patients with underlying liver cirrhosis and ascitic fluid that is routinley punctured.
Who may be able to join
- Underlying decompensated liver cirrhosis
- routinely performed ascitic fluid puncture
- informed consent
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Ascitic fluid microbiome is going to be investigated in this study by using internal transcripted spacer (ITS) and 16S ribosomal RNA (rRNA) polymerase chain reaction (PCR) and sequencing as conventional culture methods are lacking sensitivity regarding diagnosis of spontaneous bacterial peritonitis (SBP).
All patients with routinely performed ascitic fluid puncture and underlying liver cirrhosis are included in this study. Next generation sequencing (NGS) in ascitic fluid, skin swaps from puncture side and stool samples as well as conventional culture methods are performed to investigate the difference in the microbiome between patients with and without SBP.
- Being tested
- Ascitic fluid puncture, Skin swaps from puncture side, Stool samples
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ascitic fluid punctureOther
Skin swaps from puncture sideOther
Stool samplesOther
| Study group | Role | What they receive |
|---|---|---|
| Patients with liver cirrhosis and with SBP | Not described Receives: Other: Ascitic fluid puncture; Other: Skin swaps from puncture side; Other: Stool samples | |
| Patients with liver cirrhosis and without SBP | Not described Receives: Other: Ascitic fluid puncture; Other: Skin swaps from puncture side; Other: Stool samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Next generation sequencing results from ascitic fluid samples
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionSep 2017
- Study completionSep 2017
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ascitic Fluid, MicrobiotaStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Collaborators
- CBmed - Center for biomarker research in medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02813590
- Sponsor's protocol ID
- 25-326 ex 12/13
- Status last verified
- Mar 2024
- First submitted
- 16 Jun 2016
- Last updated
- 15 Mar 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ascitic Fluid Microbiome in Liver Cirrhosis
- ClinicalTrials.gov ID
- NCT02813590
- Acronym / sponsor ID
- 25-326 ex 12/13
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Collaborators
- CBmed - Center for biomarker research in medicine
- Study start
- Jun 2016 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 27 Jun 2016 (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.
Ascitic fluid microbiome is going to be investigated in this study by using internal transcripted spacer (ITS) and 16S ribosomal RNA (rRNA) polymerase chain reaction (PCR) and sequencing as conventional culture methods are lacking sensitivity regarding diagnosis of spontaneous bacterial peritonitis (SBP).
All patients with routinely performed ascitic fluid puncture and underlying liver cirrhosis are included in this study. Next generation sequencing (NGS) in ascitic fluid, skin swaps from puncture side and stool samples as well as conventional culture methods are performed to investigate the difference in the microbiome between patients with and without SBP.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with liver cirrhosis and with SBP | – | Other: Ascitic fluid puncture, Other: Skin swaps from puncture side, Other: Stool samples |
| Patients with liver cirrhosis and without SBP | – | Other: Ascitic fluid puncture, Other: Skin swaps from puncture side, Other: Stool samples |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with underlying liver cirrhosis and ascitic fluid that is routinley punctured.
Key inclusion criteria (3 listed)
- Underlying decompensated liver cirrhosis
- routinely performed ascitic fluid puncture
- informed consent
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Ascitic fluid puncture | Other | Patients with liver cirrhosis and with SBP, Patients with liver cirrhosis and without SBP |
| Skin swaps from puncture side | Other | Patients with liver cirrhosis and with SBP, Patients with liver cirrhosis and without SBP |
| Stool samples | Other | Patients with liver cirrhosis and with SBP, Patients with liver cirrhosis and without SBP |
Primary outcome
Next generation sequencing results from ascitic fluid samples
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Ascitic Fluid, Microbiota and Microbiota, run by Medical University of Graz at 1 site in Austria.
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 3 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: withdrawn, as of the sponsor's last update on 15 Mar 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 Austria. 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 was withdrawn before enrolling participants, so there are no results.
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?
Next generation sequencing results from ascitic fluid samples (time frame: 1 year). 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 15 Mar 2024.