Condition category
Digestive System
Date applied
31/05/2004
Date assigned
14/07/2004
Last edited
27/04/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.pancreatitis.nl/

Contact information

Type

Scientific

Primary contact

Prof H G Gooszen

ORCID ID

Contact details

UMC Utrecht
Department of Surgery
HP G04.228
Heidelberglaan 100
Utrecht
3584 CX
Netherlands
+31 (0)30 250 8074
h.gooszen@chir.azu.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

03/169

Study information

Scientific title

Acronym

PROPATRIA

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.

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Acute pancreatitis

Intervention

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.

Intervention type

Drug

Phase

Not Specified

Drug names

Probiotics

Primary outcome measures

Total number of infectious complications.

Secondary outcome measures

1. Costs
2. Hospital stay
3. Intesive care unit (ICU) stay
4. Mortality
5. Morbidity

Overall trial start date

01/03/2004

Overall trial end date

01/12/2006

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200

Participant 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

Recruitment start date

01/03/2004

Recruitment end date

01/12/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

UMC Utrecht
Utrecht
3584 CX
Netherlands

Sponsor information

Organisation

University Medical Centre Utrecht (UMCU) (Netherlands)

Sponsor details

c/o Prof. dr. H.G. Gooszen
Department of Surgery
HP G04.228
Heidelberglaan 100
Utrecht
3584 CX
Netherlands
+31 (0)30 250 8074
h.gooszen@chir.azu.nl

Sponsor type

University/education

Website

http://www.umcutrecht.nl/zorg/

Funders

Funder type

Government

Funder name

Senter (Netherlands) - http://www.senter.nl, an agency of the Ministry of Economic Affairs

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

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)

Publication citations

  1. Besselink MG, Timmerman HM, Buskens E, Nieuwenhuijs VB, Akkermans LM, Gooszen HG, , Probiotic prophylaxis in patients with predicted severe acute pancreatitis (PROPATRIA): design and rationale of a double-blind, placebo-controlled randomised multicenter trial [ISRCTN38327949]., BMC Surg, 2004, 4, 12, doi: 10.1186/1471-2482-4-12.

  2. Besselink MG, van Santvoort HC, Buskens E, Boermeester MA, van Goor H, Timmerman HM, Nieuwenhuijs VB, Bollen TL, van Ramshorst B, Witteman BJ, Rosman C, Ploeg RJ, Brink MA, Schaapherder AF, Dejong CH, Wahab PJ, van Laarhoven CJ, van der Harst E, van Eijck CH, Cuesta MA, Akkermans LM, Gooszen HG, , Probiotic prophylaxis in predicted severe acute pancreatitis: a randomised, double-blind, placebo-controlled trial., Lancet, 2008, 371, 9613, 651-659, doi: 10.1016/S0140-6736(08)60207-X.

Additional files

Editorial Notes