Evidence map›Paper›PMID 15456517›Full record

Trial reportBMC surgery2004

Probiotic prophylaxis in patients with predicted severe acute pancreatitis (PROPATRIA): design and rationale of a double-blind, placebo-controlled randomised multicenter trial [ISRCTN38327949].

Marc G H Besselink, Harro M Timmerman, Erik Buskens, Vincent B Nieuwenhuijs, Louis M A Akkermans, Hein G Gooszen, Dutch Acute Pancreatitis Study Group

Open access · goldAbstract readClinical TrialRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC surgery, 2004. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 5 pooled it
7.2field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 5 syntheses or guidelines pooled it, 97 citations in OpenAlex.

  1. Pharmacological interventions for acute pancreatitis.The Cochrane database of systematic reviews · 2017
    Pooled it
  2. Enteral nutrition formulations for acute pancreatitis.The Cochrane database of systematic reviews · 2015
    Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Trial
  7. Article
  8. Review
  9. Review
  10. Article
  11. Acute pancreatitis is associated with gut dysbiosis in children.Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver · 2024
    Observational
  12. Review
  13. Microbial Therapeutics in Neurocognitive and Psychiatric Disorders.Journal of clinical medicine research · 2021
    Review
  14. Review
  15. Review
  16. Review
  17. The Gut Microbiome in Pancreatic Disease.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2019
    Review
  18. Article
  19. Review
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 2 institutions in 1 country.

Marc G H BesselinkDepartment of Surgery, University Medical Center Utrecht PO Box 85500, HP G04,228, 3508 GA Utrecht, The Netherlands. m.besselink@chir.azu.nl
Harro M Timmerman
Erik Buskens
Vincent B Nieuwenhuijs
Louis M A Akkermans
Hein G Gooszen
Dutch Acute Pancreatitis Study Group
University Medical Center Utrecht · NLUtrecht University · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundInfectious 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. METHODS/

designPROPATRIA is a double-blind, placebo-controlled randomised multicenter trial in which 200 patients will be randomly allocated to a multispecies probiotic preparation (Ecologic 641) or placebo. The study is performed in all 8 Dutch University Hospitals and 7 non-University hospitals. The study-product is administered twice daily through a nasojejunal tube for 28 days or until discharge. Patients eligible for randomisation are adult patients with a first onset of predicted severe acute pancreatitis: Imrie criteria 3 or more, CRP 150 mg/L or more, APACHE II score 8 or more. Exclusion criteria are post-ERCP pancreatitis, malignancy, infection/sepsis caused by a second disease, intra-operative diagnosis of pancreatitis and use of probiotics during the study. Administration of the study product is started within 72 hours after onset of abdominal pain. The primary endpoint is the total number of infectious complications. Secondary endpoints are mortality, necrosectomy, antibiotic resistance, hospital stay and adverse events. To demonstrate that probiotic prophylaxis reduces the proportion of patients with infectious complications from 50% to 30%, with alpha 0,05 and power 80%, a total sample size of 200 patients was calculated.

conclusionThe PROPATRIA study is aimed to show a reduction in infectious complications due to early enteral use of multispecies probiotics in severe acute pancreatitis.

Indexed as

Acute DiseaseAdultDouble-Blind MethodFollow-Up StudiesHumansLactiplantibacillus plantarumMulticenter Studies as TopicNecrosisPancreasPancreatitisProbioticsRandomized Controlled Trials as TopicResearch DesignSample Size

Identifiers

PMID15456517
PMCPMC526218
OpenAlexW2113079178

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.