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Microbiota in Acute Pancreatitis: Prospective Multicenter Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04038554
Recruitment Status : Not yet recruiting
First Posted : July 31, 2019
Last Update Posted : March 18, 2020
Sponsor:
Information provided by (Responsible Party):
Maria Nieves García-Monforte, 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.


Condition or disease Intervention/treatment
Acute Pancreatitis Microbial Colonization 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 .

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Study Type : Observational
Estimated Enrollment : 168 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Microbiota in Acute Pancreatitis: Prospective Multicenter Study
Estimated Study Start Date : May 1, 2020
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Number and proportion of different microbiological taxonomic groups in fecal and salival samples determined by mRNA sequencing and PCR amplification (Microbiota Composition). [ Time Frame: 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 :
  1. Microbiota composition with respect to pancreatitis etiology assessed by clinical history and complementary tests. [ Time Frame: 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).


  2. Microbiota composition with respect to pancreatitis severity [ Time Frame: Two determinations: at recruitment and after one month of discharge. ]
    Microbiota composition with respect to pancreatitis severity according to Atlanta 2012 criteria


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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04038554


Contacts
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Contact: MNieves García-Monforte, PhD +34629362957 neusgmonforte@gmail.com

Locations
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Spain
Corporacion Sanitaria Parc Taulí
Sabadell, Barcelona, Spain, 08208
Contact: MNieves García, PhD    +34629362957    neusgarciamonforte@gmail.com   
Fundación Instituto de Investigación Pere i Virgili
Tarragona, Spain, 43003
Sponsors and Collaborators
Corporacion Parc Tauli
Investigators
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Principal Investigator: MNieves García-Monforte, PhD Corporacion Sanitaria Parc Tauli
Principal Investigator: Robert Memba Ikuga, PhD Fundacion Instituto de Investigacion Pere i Virgili
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Responsible Party: Maria Nieves García-Monforte, Senior doctor of Hepatobiliopancreatic Surgery department, Corporacion Parc Tauli
ClinicalTrials.gov Identifier: NCT04038554    
Other Study ID Numbers: CSPT-CG-MPA
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: March 18, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Communicable Diseases
Infection
Pancreatitis
Pancreatic Diseases
Digestive System Diseases