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ISRCTN
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ISRCTN38327949
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DOI
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10.1186/ISRCTN38327949
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Probiotic prophylaxis in patients with predicted severe acute pancreatitis: placebo-controlled randomised clinical trial. Dutch Acute Pancreatitis Study Group
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Scientific title
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Acronym
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PROPATRIA
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Serial number at source
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03/169
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Study hypothesis
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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.
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Lay summary
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Ethics approval
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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.
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Study design
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Multicentre placebo controlled randomised trial
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Countries of recruitment
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Netherlands
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Disease/condition/study domain
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Acute pancreatitis
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/03/2004
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Anticipated end date
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01/12/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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200
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Interventions
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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.
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Primary outcome measure(s)
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Total number of infectious complications.
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Secondary outcome measure(s)
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1. Costs
2. Hospital stay
3. Intesive care unit (ICU) stay
4. Mortality
5. Morbidity
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Sources of funding
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Senter (Netherlands) - http://www.senter.nl, an agency of the Ministry of Economic Affairs
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Trial website
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http://www.pancreatitis.nl/
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Publications
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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)
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Contact name
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Prof
H G
Gooszen
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Address
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UMC Utrecht
Department of Surgery
HP G04.228
Heidelberglaan 100
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City/town
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Utrecht
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Zip/Postcode
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3584 CX
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Country
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Netherlands
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Tel
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+31 (0)30 250 8074
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Fax
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+31 (0)30 254 1944
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Email
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h.gooszen@chir.azu.nl
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Sponsor
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University Medical Centre Utrecht (UMCU) (Netherlands)
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Address
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c/o Prof. dr. H.G. Gooszen
Department of Surgery
HP G04.228
Heidelberglaan 100
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City/town
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Utrecht
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Zip/Postcode
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3584 CX
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Country
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Netherlands
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Tel
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+31 (0)30 250 8074
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Fax
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+31 (0)30 254 1944
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Email
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h.gooszen@chir.azu.nl
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Sponsor website:
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http://www.umcutrecht.nl/zorg/
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Date applied
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31/05/2004
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Last edited
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27/04/2009
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Date ISRCTN assigned
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14/07/2004
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