Microbiota in Acute Pancreatitis: Prospective Multicenter Study

Study Overview
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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 .

Official Title
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Microbiota in Acute Pancreatitis: Prospective Multicenter Study

Conditions
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Acute Pancreatitis, Microbial Colonization

Intervention / Treatment
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* Diagnostic Test: Feces and saliva analysis


Participation Criteria
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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: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Acute Pancreatitis<br>Patients older than 18 years old diagnosed of acute pancreatitis according to Atlanta 2012. | Diagnostic Test: Feces and saliva analysis<br>* Qualitative and quantitative analysis of the microbiota in the feces and saliva by mRNA sequencing.<br>|
| Healthy Control<br>Healthy people with a proximity relationship with case patients and similar age (+/- 5 years). | Diagnostic Test: Feces and saliva analysis<br>* Qualitative and quantitative analysis of the microbiota in the feces and saliva by mRNA sequencing.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Two determinations: at recruitment and after one month of discharge. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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 | Two determinations: at recruitment and after one month of discharge. |