Gut dysbiosis drives disease processes driving morbidity and mortality in acute pancreatitis, such as infected pancreatic necrosis, and (persistent) multiple organ failure. A decrease in commensal members of the bacterial microbiome allows for…
Bron
Verkorte titel
Aandoening
Acute Pancreatitis
Ondersteuning
Onderzoeksproduct en/of interventie
Geen registraties gevonden.
Uitkomstmaten
Primaire uitkomstmaten
Objective 1: Moderate severe or severe acute pancreatitis, as defined by the revised Atlanta criteria.
Objective 2: Infectious complications (defined as infected necrosis, bacteraemia and/or pneumonia)
Achtergrond van het onderzoek
Rationale: Around 20% of patients with acute pancreatitis develop necrotizing pancreatitis. Mortality is driven by early organ failure and late organ failure due to infected necrosis (i.e. moderately severe / severe acute pancreatitis). Clinical risk factors for disease severity are largely unknown. Bacterial translocation from the gut is likely to play a role in the development of infectious complications. We hypothesize that alterations of the gut microbiota and metabolic function are associated with disease severity in the early phase of acute pancreatitis and also with infectious complications in the late phase.
Objective:
1) To establish associations between microbiome profiles and disease severity in patients with acute pancreatitis.
2) To establish associations between specific microbial shifts and infectious complications in the subgroup of patients with necrotizing pancreatitis.
Study design: Prospective multicenter observational study
Study population: 250 adult patients presenting with a primary episode of acute pancreatitis
Main study parameters/endpoints: The main endpoints are 1) moderate severe or severe acute pancreatitis, as defined by the revised Atlanta criteria, 2) infectious complications (defined as infected necrosis, bacteraemia and/or pneumonia). The main study parameters are microbiome profiling (16S rRNA sequencing) of faeces, saliva and blood.
Doel van het onderzoek
Gut dysbiosis drives disease processes driving morbidity and mortality in acute pancreatitis, such as infected pancreatic necrosis, and (persistent) multiple organ failure. A decrease in commensal members of the bacterial microbiome allows for opportunistic pathogens to overgrow the intestine, or to acquire additional virulence factors so they can invade the host and cause infections. Besides the microbiome composition, its metabolic functions could be related to the development of complications in acute pancreatitis. The loss of functional properties of metabolite-producing colonic bacteria can lead to diminished gut regeneration, increased intestinal barrier dysfunction and thereby facilitate bacterial translocation and disease progression of acute pancreatitis. Therefore, the gut microbiome is a promising novel target to improve diagnosis, prevention and treatment of infectious and systematic complications of acute pancreatitis.
Onderzoeksopzet
Within 72 hours of disease onset. For patients with predicted severe, samples are collected every 72 hours with a maximum of 8 timepoints.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
First episode of acute pancreatitis
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- Disease onset longer than 72 hours.
- Younger than 18 years old
- History of recurrent or chronic pancreatitis
- Current or recent (last 2 months) antibiotic use
- Pregnancy
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
Register | ID |
---|---|
NTR-new | NL7789 |
Ander register | MEC-U : R19.034 |