Microbiota in Acute Pancreatitis: Prospective Multicenter Study

NCT ID: NCT04038554

Last Updated: 2020-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

168 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-01

Study Completion Date

2020-09-01

Brief Summary

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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

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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

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Acute Pancreatitis Microbial Colonization

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Acute Pancreatitis

Patients older than 18 years old diagnosed of acute pancreatitis according to Atlanta 2012.

Feces and saliva analysis

Intervention Type DIAGNOSTIC_TEST

Qualitative and quantitative analysis of the microbiota in the feces and saliva by mRNA sequencing.

Healthy Control

Healthy people with a proximity relationship with case patients and similar age (+/- 5 years).

Feces and saliva analysis

Intervention Type DIAGNOSTIC_TEST

Qualitative and quantitative analysis of the microbiota in the feces and saliva by mRNA sequencing.

Interventions

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Feces and saliva analysis

Qualitative and quantitative analysis of the microbiota in the feces and saliva by mRNA sequencing.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Corporacion Parc Tauli

OTHER

Sponsor Role lead

Responsible Party

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Maria Nieves García-Monforte

Senior doctor of Hepatobiliopancreatic Surgery department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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MNieves García-Monforte, PhD

Role: PRINCIPAL_INVESTIGATOR

Corporacion Sanitaria Parc Tauli

Robert Memba Ikuga, PhD

Role: PRINCIPAL_INVESTIGATOR

Fundacion Instituto de Investigacion Pere i Virgili

Locations

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Corporacion Sanitaria Parc Taulí

Sabadell, Barcelona, Spain

Site Status

Fundación Instituto de Investigación Pere i Virgili

Tarragona, , Spain

Site Status

Countries

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Spain

Central Contacts

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MNieves García-Monforte, PhD

Role: CONTACT

+34629362957

Facility Contacts

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MNieves García, PhD

Role: primary

+34629362957

Other Identifiers

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CSPT-CG-MPA

Identifier Type: -

Identifier Source: org_study_id

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