Probiotic prophylaxis in patients with predicted severe acute pancreatitis: placebo-controlled randomised clinical trial. Dutch Acute Pancreatitis Study Group
| ISRCTN | ISRCTN38327949 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN38327949 |
| Secondary identifying numbers | 03/169 |
- Submission date
- 31/05/2004
- Registration date
- 14/07/2004
- Last edited
- 27/04/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof H G Gooszen
Scientific
Scientific
UMC Utrecht
Department of Surgery
HP G04.228
Heidelberglaan 100
Utrecht
3584 CX
Netherlands
| Phone | +31 (0)30 250 8074 |
|---|---|
| h.gooszen@chir.azu.nl |
Study information
| Study design | Multicentre placebo controlled randomised trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | PROPATRIA |
| Study objectives | 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(s) | 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. |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Probiotics |
| Primary outcome measure | Total number of infectious complications. |
| Secondary outcome measures | 1. Costs 2. Hospital stay 3. Intesive care unit (ICU) stay 4. Mortality 5. Morbidity |
| Overall study start date | 01/03/2004 |
| Completion date | 01/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 200 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/03/2004 |
| Date of final enrolment | 01/12/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
UMC Utrecht
Utrecht
3584 CX
Netherlands
3584 CX
Netherlands
Sponsor information
University Medical Centre Utrecht (UMCU) (Netherlands)
University/education
University/education
c/o Prof. dr. H.G. Gooszen
Department of Surgery
HP G04.228
Heidelberglaan 100
Utrecht
3584 CX
Netherlands
| Phone | +31 (0)30 250 8074 |
|---|---|
| h.gooszen@chir.azu.nl | |
| Website | http://www.umcutrecht.nl/zorg/ |
"ROR" |
https://ror.org/04pp8hn57 |
Funders
Funder type
Government
Senter (Netherlands) - http://www.senter.nl, an agency of the Ministry of Economic Affairs
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 29/09/2004 | Yes | No | |
| Results article | results | 23/02/2008 | Yes | No |
