Microbiota in Acute Pancreatitis: Prospective Multicenter Study

Microbial Colonization Clinical Trial

Official title:

Microbiota in Acute Pancreatitis: Prospective Multicenter Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04038554
• Other study ID #: CSPT-CG-MPA
• Status: Not yet recruiting
• Start date: May 1, 2020
• Est. completion date: September 1, 2020

Study information

• Verified date: March 2020
• Source: Corporacion Parc Tauli
• Contact: MNieves García-Monforte, PhD
• Phone: +34629362957
• Email: neusgmonforte[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 168
• Est. completion date: September 1, 2020
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

-

Related Conditions & MeSH terms

• Acute Pancreatitis
• Communicable Diseases
• Infection
• Microbial Colonization
• Pancreatitis

Intervention

Diagnostic Test:
• Feces and saliva analysis
Qualitative and quantitative analysis of the microbiota in the feces and saliva by mRNA sequencing.

Locations

Country	Name	City	State
Spain	Corporacion Sanitaria Parc Taulí	Sabadell	Barcelona
Spain	Fundación Instituto de Investigación Pere i Virgili	Tarragona

Sponsors (1)

Lead Sponsor	Collaborator
Corporacion Parc Tauli

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.