Microbiota in Acute Pancreatitis: Prospective Multicenter Study

NCT04038554 | Unknown

• 1 other identifier: CSPT-CG-MPA
• Study Type: observational
• Target: 168
• Locations: 1 country
• Sites: 2

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.

Conditions

Acute Pancreatitis; Microbial Colonization

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Microbiota composition with respect to pancreatitis etiology assessed by clinical history and complementary tests.

  Two determinations: at recruitment and after one month of discharge.

• Microbiota composition with respect to pancreatitis severity

  Two determinations: at recruitment and after one month of discharge.

Study Arms (2)

Acute Pancreatitis

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

Diagnostic Test: Feces and saliva analysis

Healthy Control

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

Diagnostic Test: Feces and saliva analysis

Interventions

Feces and saliva analysis DIAGNOSTIC_TEST

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

Acute Pancreatitis; Healthy Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

Sponsors & Collaborators

• Corporacion Parc Tauli: lead

Study Sites (2)

Corporacion Sanitaria Parc Taulí

Sabadell, Barcelona, 08208, Spain

Location

Fundación Instituto de Investigación Pere i Virgili

Tarragona, 43003, Spain

Location

Biospecimen

Retention: SAMPLES WITH DNA

Qualitative and quantitative description of bacterial species present in feces and saliva samples from patients diagnosed with acute pancreatitis of different grades and etiologies

MeSH Terms

Conditions

Pancreatitis; Communicable Diseases

Interventions

Defecation

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• MNieves García-Monforte, PhD

  Corporacion Sanitaria Parc Tauli

  PRINCIPAL INVESTIGATOR

• Robert Memba Ikuga, PhD

  Fundacion Instituto de Investigacion Pere i Virgili

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MNieves García-Monforte, PhD

CONTACT

+34629362957; neusgmonforte@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior doctor of Hepatobiliopancreatic Surgery department

Study Record Dates

• First Submitted: June 18, 2019
• First Posted: July 31, 2019
• Study Start: May 1, 2020
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: March 18, 2020

Record last verified: 2020-03

Locations

ES (2)