Microbiota in Acute Pancreatitis: Prospective Multicenter 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.

Study Overview

• Status: Unknown
• Conditions: Microbial Colonization; Acute Pancreatitis
• Intervention / Treatment: Diagnostic test: Feces and saliva analysis

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 Type: Observational
• Enrollment (Anticipated): 168

Contacts and Locations

Study Locations

• Spain
  • Tarragona, Spain, 43003
    • Fundación Instituto de Investigación Pere i Virgili
  • Barcelona
    • Sabadell, Barcelona, Spain, 08208
      • Corporacion Sanitaria Parc Tauli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Acute Pancreatitis; Patients older than 18 years old diagnosed of acute pancreatitis according to Atlanta 2012.	Diagnostic test: Feces and saliva analysis; 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).	Diagnostic test: Feces and saliva analysis; Qualitative and quantitative analysis of the microbiota in the feces and saliva by mRNA sequencing.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Corporacion Parc Tauli
• Investigators: Principal Investigator: MNieves García-Monforte, PhD, Corporacion Sanitaria Parc Tauli; Principal Investigator: Robert Memba Ikuga, PhD, Fundación Instituto de Investigación Pere i Virgili

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2020
• Primary Completion (Anticipated): September 1, 2020
• Study Completion (Anticipated): September 1, 2020

Study Registration Dates

• First Submitted: June 18, 2019
• First Submitted That Met QC Criteria: July 26, 2019
• First Posted (Actual): July 31, 2019

Study Record Updates

• Last Update Posted (Actual): March 18, 2020
• Last Update Submitted That Met QC Criteria: March 16, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease Attributes; Pancreatic Diseases; Infections; Communicable Diseases; Pancreatitis
• Other Study ID Numbers: CSPT-CG-MPA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No