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Probiotic prophylaxis in patients with predicted severe acute pancreatitis: placebo-controlled randomised clinical trial. Dutch Acute Pancreatitis Study Group
ISRCTN ISRCTN38327949
DOI 10.1186/ISRCTN38327949
ClinicalTrials.gov identifier
EudraCT number
Public title Probiotic prophylaxis in patients with predicted severe acute pancreatitis: placebo-controlled randomised clinical trial. Dutch Acute Pancreatitis Study Group
Scientific title
Acronym PROPATRIA
Serial number at source 03/169
Study hypothesis Infectious complications are the major cause of death in acute pancreatitis. Small bowel bacterial overgrowth and subsequent bacterial translocation are held responsible for the vast majority of these infections. Goal of this study is to determine whether selected probiotics are capable of preventing infectious complications without the disadvantages of antibiotic prophylaxis; antibiotic resistance and fungal overgrowth.
Lay summary
Ethics approval This study is conducted in accordance with the principles of the Declaration of Helsinki and 'good clinical practice' guidelines. The independent ethics committee of all 15 participating hospitals approved the final protocol. Oral and written informed consent in form is obtained from the patient before inclusion in the trial.
Study design Multicentre placebo controlled randomised trial
Countries of recruitment Netherlands
Disease/condition/study domain Acute pancreatitis
Participants - inclusion criteria Patients of all Dutch University Hospitals and major non-University Hospitals who are admitted with predicted severe acute pancreatitis.

Added Feb 2008:
1. Age equal to or above 18 years
2. First episode of acute pancreatitis
3. Written and oral informed consent
Participants - exclusion criteria Added Feb 2008:
1. Post-ERCP pancreatitis
2. Malignancy
3. Infection/sepsis caused by a second disease
4. Intra-operative diagnosis
5. Immunocompromised patients
6. Use of probiotics during admission
Anticipated start date 01/03/2004
Anticipated end date 01/12/2006
Status of trial Completed
Patient information material
Target number of participants 200
Interventions Patients are randomly assigned to receive either live multispecies probiotics (6 strains, Ecologic 641) or placebo for 4 weeks by nasojejunal tube. Treatment is started within 72 hours after onset of abdominal pain.
Primary outcome measure(s) Total number of infectious complications.
Secondary outcome measure(s) 1. Costs
2. Hospital stay
3. Intesive care unit (ICU) stay
4. Mortality
5. Morbidity
Sources of funding Senter (Netherlands) - http://www.senter.nl, an agency of the Ministry of Economic Affairs
Trial website http://www.pancreatitis.nl/
Publications 2004 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/15456517 (BMC Surgery)
2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18279948 (Lancet)
Contact name Prof  H G  Gooszen
  Address UMC Utrecht
Department of Surgery
HP G04.228
Heidelberglaan 100
  City/town Utrecht
  Zip/Postcode 3584 CX
  Country Netherlands
  Tel +31 (0)30 250 8074
  Fax +31 (0)30 254 1944
  Email h.gooszen@chir.azu.nl
Sponsor University Medical Centre Utrecht (UMCU) (Netherlands)
  Address c/o Prof. dr. H.G. Gooszen
Department of Surgery
HP G04.228
Heidelberglaan 100
  City/town Utrecht
  Zip/Postcode 3584 CX
  Country Netherlands
  Tel +31 (0)30 250 8074
  Fax +31 (0)30 254 1944
  Email h.gooszen@chir.azu.nl
  Sponsor website: http://www.umcutrecht.nl/zorg/
Date applied 31/05/2004
Last edited 27/04/2009
Date ISRCTN assigned 14/07/2004
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