Clinical trial NCT04038554: Microbiota in Acute Pancreatitis: Prospective Multicenter Study
Official title: Microbiota in Acute Pancreatitis: Prospective Multicenter Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Pancreatitis
Microbial Colonization
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
First posted: 2019-07-31
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients older than 18 years old diagnosed of acute pancreatitis according to Atlanta 2012 criteria with no etnia, gender or comorbilities restriction.

Brief 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. 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 .

Eligibility criteria: 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:

-

Primary outcomes:
measure: Number and proportion of different microbiological taxonomic groups in fecal and salival samples determined by mRNA sequencing and PCR amplification (Microbiota Composition).
timeFrame: Two determinations: at recruitment and after one month of discharge.
Secondary outcomes:
measure: Microbiota composition with respect to pancreatitis etiology assessed by clinical history and complementary tests.
timeFrame: Two determinations: at recruitment and after one month of discharge.
measure: Microbiota composition with respect to pancreatitis severity
timeFrame: Two determinations: at recruitment and after one month of discharge.
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Corporacion Sanitaria Parc Taulí
state: Barcelona
city: Tarragona
country: Spain
facility: Fundación Instituto de Investigación Pere i Virgili
Study officials:
affiliation: Corporacion Sanitaria Parc Tauli
name: MNieves García-Monforte, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fundacion Instituto de Investigacion Pere i Virgili
name: Robert Memba Ikuga, PhD
role: PRINCIPAL_INVESTIGATOR
References: