Microbiota in Acute Pancreatitis: Prospective Multicenter Study

• Conditions: Acute Pancreatitis; Microbial Colonization

• Registration Number: NCT04038554
• Lead Sponsor: Corporacion Parc Tauli

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 .

Study Timeline

• Study First Submitted: 2019-06-18
• Study First Submitted QC: 2019-07-26
• Study First Posted: 2019-07-31
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-16
• Last Update Posted: 2020-03-18
• Study Start: 2020-05-01
• Primary Completion: 2020-09-01
• Study Completion: 2020-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 168

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number and proportion of different microbiological taxonomic groups in fecal and salival samples determined by mRNA sequencing and PCR amplification (Microbiota Composition).	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.

Secondary Outcome Measures

Name	Time	Method
Microbiota composition with respect to pancreatitis severity	Two determinations: at recruitment and after one month of discharge.	Microbiota composition with respect to pancreatitis severity according to Atlanta 2012 criteria
Microbiota composition with respect to pancreatitis etiology assessed by clinical history and complementary tests.	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 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).

Trial Locations

Locations (2)

Corporacion Sanitaria Parc Taulí; 🇪🇸 Sabadell, Barcelona, Spain

Fundación Instituto de Investigación Pere i Virgili; 🇪🇸 Tarragona, Spain