Acute PancreatitisNCT04038554
Microbiota in Acute Pancreatitis: Prospective Multicenter Study
An observational study of Acute Pancreatitis and Microbial Colonization, run by Corporacion Parc Tauli at 2 sites in Spain.
Trial summary
The objective of the study is to classify and carry out a quantitative analysis of the different bacterial species present in the intestinal microbiota of patients with acute pancreatitis and determine if there are significant differences regarding healthy controls. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Pancreatitis, Microbial Colonization
- What is being tested?
- Feces and saliva analysis
- How many people
- 168 participants
- Where
- 2 sitesSpain
- Study dates
- 1 May 2020to 1 Sep 2020
- 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: Patients older than 18 years old diagnosed of acute pancreatitis according to Atlanta 2012 criteria with no etnia, gender or comorbilities restriction.
Who may be able to join
- Case patients: adult patients diagnosed of acute pancreatitis according to Atlanta 2012 criteria
- Healthy controls: healthy people with a proximity relationship with case patients and similar age (+/- 5 years. Doesn't have to be a parental relationship.
Who cannot join
- -
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Corporacion Sanitaria Parc Taulí
Sabadell, Barcelona, 08208
MNieves García, PhD, +34629362957, neusgarciamonforte@gmail.com
Fundación Instituto de Investigación Pere i Virgili
Tarragona, 43003
About this study
The objective of the study is to classify and carry out a quantitative analysis of the different bacterial species present in the intestinal microbiota of patients with acute pancreatitis and determine if there are significant differences regarding healthy controls. At the same time, the investigators pretend to determine if there are differences according to the etiology and severity of the disease and if the disregulation is temporary or is maintained after one month of discharge.
To carry out this purpose, the investigators have designed a prospective and multicentre observational study where samples of feces and saliva of patients admitted for acute pancreatitis of different etiologies and severity will be analyzed.
Read the detailed description
The study of the human microbiota is gaining importance given its relationship with the homeostasis of the organism as well as with certain pathologies. Specifically in the case of acute and chronic pancreatitis, recent studies suggest the disregulation of the intestinal flora as a possible determinant in the development and evolution of the disease. If this hypothesis is confirmed, hygienic-dietetic measures, as well as the administration of antibiotics, probiotics or fecal transplantation, may have therapeutic implications.
The objective of the study is to classify and carry out a quantitative analysis of the different bacterial species present in the intestinal microbiota of patients with acute pancreatitis and determine if there are significant differences regarding healthy controls. At the same time, the investigators also intend to determine if there are differences according to the etiology and severity of the disease and if the disregulation is temporary or is maintained after one month of discharge.
To carry out this purpose, it has been designed a prospective and multicentre observational study where samples of feces and saliva of patients admitted for acute pancreatitis of different etiologies and severity will be analyzed .
- Conditions
- Acute Pancreatitis, Microbial Colonization
- Being tested
- Feces and saliva analysis
- Medical subject headings
- Pancreatitis, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feces and saliva analysisDiagnostic test
Qualitative and quantitative analysis of the microbiota in the feces and saliva by mRNA sequencing.
| Study group | Role | What they receive |
|---|---|---|
| Acute Pancreatitis | Patients older than 18 years old diagnosed of acute pancreatitis according to Atlanta 2012. Receives: Diagnostic Test: Feces and saliva analysis | |
| Healthy Control | Healthy people with a proximity relationship with case patients and similar age (+/- 5 years). Receives: Diagnostic Test: Feces and saliva analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and proportion of different microbiological taxonomic groups in fecal and salival samples determined by mRNA sequencing and PCR amplification (Microbiota Composition).
Assessment of the different number of microbiological taxonomic groups and the proportion of them in fecal and salival samples from patients with acute pancreatitis by mRNA sequencing and PCR amplification using Illumina sequency techonology.
Measured: Two determinations: at recruitment and after one month of discharge.
Secondary outcomes (2)
Microbiota composition with respect to pancreatitis etiology assessed by clinical history and complementary tests.
Assessment of the different number of microbiological taxonomic groups and the proportion of them in fecal and salival samples from patients with different etiology of acute pancreatitis by mRNA sequencing and PCR amplification using Illumina sequency techonology.
The pancreatitis etiology will be defined according to clinical history (e.g alcohol consumption, cholelitiasis, metabolic and inmune disorders) and complementary tests (US, CT scan and blood tests).
Measured: Two determinations: at recruitment and after one month of discharge.
Microbiota composition with respect to pancreatitis severity
Microbiota composition with respect to pancreatitis severity according to Atlanta 2012 criteria
Measured: Two determinations: at recruitment and after one month of discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2019
- Study start1 May 2020 (estimated)
- Primary completion1 Sep 2020 (estimated)
- Study completion1 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PancreatitisStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Nieves García-Monforte, Corporacion Parc Tauli
- Investigators
- MNieves García-Monforte, PhD, Principal investigator, Corporacion Sanitaria Parc TauliRobert Memba Ikuga, PhD, Principal investigator, Fundacion Instituto de Investigacion Pere i Virgili
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04038554
- Sponsor's protocol ID
- CSPT-CG-MPA
- Status last verified
- Mar 2020
- First submitted
- 18 Jun 2019
- Last updated
- 18 Mar 2020
- 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 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiota in Acute Pancreatitis: Prospective Multicenter Study
- ClinicalTrials.gov ID
- NCT04038554
- Acronym / sponsor ID
- CSPT-CG-MPA
- Conditions
- Acute Pancreatitis, Microbial Colonization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- 1 May 2020 (estimated)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 1 Sep 2020 (estimated)
- First posted
- 31 Jul 2019 (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 objective of the study is to classify and carry out a quantitative analysis of the different bacterial species present in the intestinal microbiota of patients with acute pancreatitis and determine if there are significant differences regarding healthy controls. At the same time, the investigators pretend to determine if there are differences according to the etiology and severity of the disease and if the disregulation is temporary or is maintained after one month of discharge.
To carry out this purpose, the investigators have designed a prospective and multicentre observational study where samples of feces and saliva of patients admitted for acute pancreatitis of different etiologies and severity will be analyzed.
Detailed description
The study of the human microbiota is gaining importance given its relationship with the homeostasis of the organism as well as with certain pathologies. Specifically in the case of acute and chronic pancreatitis, recent studies suggest the disregulation of the intestinal flora as a possible determinant in the development and evolution of the disease. If this hypothesis is confirmed, hygienic-dietetic measures, as well as the administration of antibiotics, probiotics or fecal transplantation, may have therapeutic implications.
The objective of the study is to classify and carry out a quantitative analysis of the different bacterial species present in the intestinal microbiota of patients with acute pancreatitis and determine if there are significant differences regarding healthy controls. At the same time, the investigators also intend to determine if there are differences according to the etiology and severity of the disease and if the disregulation is temporary or is maintained after one month of discharge.
To carry out this purpose, it has been designed a prospective and multicentre observational study where samples of feces and saliva of patients admitted for acute pancreatitis of different etiologies and severity will be analyzed .
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute Pancreatitis | – | Diagnostic Test: Feces and saliva analysisPatients older than 18 years old diagnosed of acute pancreatitis according to Atlanta 2012. |
| Healthy Control | – | Diagnostic Test: Feces and saliva analysisHealthy people with a proximity relationship with case patients and similar age (+/- 5 years). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients older than 18 years old diagnosed of acute pancreatitis according to Atlanta 2012 criteria with no etnia, gender or comorbilities restriction.
Key inclusion criteria (2 listed)
- Case patients: adult patients diagnosed of acute pancreatitis according to Atlanta 2012 criteria
- Healthy controls: healthy people with a proximity relationship with case patients and similar age (+/- 5 years. Doesn't have to be a parental relationship.
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 |
|---|---|---|
| Feces and saliva analysisQualitative and quantitative analysis of the microbiota in the feces and saliva by mRNA sequencing. | Diagnostic test | Acute Pancreatitis, Healthy Control |
Primary outcome
Number and proportion of different microbiological taxonomic groups in fecal and salival samples determined by mRNA sequencing and PCR amplification (Microbiota Composition).
Time frame: Two determinations: at recruitment and after one month of discharge.
Assessment of the different number of microbiological taxonomic groups and the proportion of them in fecal and salival samples from patients with acute pancreatitis by mRNA sequencing and PCR amplification using Illumina sequency techonology.
2 secondary outcomes
Microbiota composition with respect to pancreatitis etiology assessed by clinical history and complementary tests.
Time frame: Two determinations: at recruitment and after one month of discharge.
Microbiota composition with respect to pancreatitis severity
Time frame: Two determinations: at recruitment and after one month of discharge.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 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.
MNieves García-Monforte, PhD principal investigator
Corporacion Sanitaria Parc Tauli
Robert Memba Ikuga, PhD principal investigator
Fundacion Instituto de Investigacion Pere i Virgili
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Pancreatitis and Microbial Colonization, run by Corporacion Parc Tauli at 2 sites in Spain.
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: status not confirmed, as of the sponsor's last update on 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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 MNieves García-Monforte, PhD (+34629362957, neusgmonforte@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and proportion of different microbiological taxonomic groups in fecal and salival samples determined by mRNA sequencing and PCR amplification (Microbiota Composition). (time frame: Two determinations: at recruitment and after one month of discharge.). 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 18 Mar 2020.