Prospective Multicenter Microbiota Study for Evaluation and Monitoring of Severe Acute Pancreatitis

Prospective Multicenter Microbiota Study for Evaluation and Monitoring of Severe Acute Pancreatitis - POEMA

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON55872

Enrollment

313

Registered

2019-08-13

Start date

2019-10-19

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute pancreatitis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: acute pancreatitis, defined as two or more of the following criteria: - abdominal pain - serum amylase or lipase more than three times the upper limit - evidence of acute pancreatitis on abdominal CT

Exclusion criteria

Exclusion criteria: - Onset of symptoms more than 72 hours - Recurrent or chronic pancreatitis - Pregnancy - Age less than 18 years old

Design outcomes

Primary

Measure	Time frame
Objective 1: Population: 313 adults patients who present with acute pancreatitis with disease onset less than 72 hours Study parameters: Microbiome profiling (16S rRNA sequencing) of feces and saliva. Main outcome parameter: Severity as defined by revised Atlanta criteria. Objective 2: Population: 40 patients with predicted severe pancreatitis (defined by serum CRP >150 mg/l, APACHE II score >7 and/or Imrie score >2 within 48 hours of admission) who retrospectively develop necrotizing pancreatitis Study parameters: Serial microbiome profiling (16S rRNA sequencing) of saliva, feces and blood Main outcome parameter: Infectious complications (defined as infected necrosis, bacteremia and/or pneumoniae)	—

Measure

Time frame

Objective 1: Population: 313 adults patients who present with acute pancreatitis with disease onset less than 72 hours Study parameters: Microbiome profiling (16S rRNA sequencing) of feces and saliva. Main outcome parameter: Severity as defined by revised Atlanta criteria. Objective 2: Population: 40 patients with predicted severe pancreatitis (defined by serum CRP >150 mg/l, APACHE II score >7 and/or Imrie score >2 within 48 hours of admission) who retrospectively develop necrotizing pancreatitis Study parameters: Serial microbiome profiling (16S rRNA sequencing) of saliva, feces and blood Main outcome parameter: Infectious complications (defined as infected necrosis, bacteremia and/or pneumoniae)

—

Secondary

Measure	Time frame
Objective 1: Secondary outcome parameters: (Peri-)pancreatic necrosis, infectious complications, transient/ persistent single/multiple organ failure and mortality.	—

Countries

Netherlands

Outcome results