- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01730066
Probiotics Against Pathogenic Bacteria in Advanced ENT-Surgery
Probiotics for Reduction of Pathogenic Bacteria in Connection With Advanced Surgery in the Mouth, the Oropharynx, and on the Neck
Surgery in the mouth and oropharynx is performed in an area colonised by bacteria non-pathogenic and pathogenic.
Antibiotics are used regularly resulting in disturbances in the intestinal microbiological flora and consequently diarrhoea that can be troublesome. The use of antibiotics throughout the hospital stay for these difficult cases represent a risk of development of resistant strains.
Most of the patients have cancer diagnoses and have radiation therapy before surgery. This increases the risk of the patients having pathogenic bacteria normally present in the lower GI-tract.
The investigators have shown for ICU patients that treatment with probiotics reduces the number of emerging enteral bacteria in the oropharynx and now the investigators will perform an adjusted procedure for patients planned for large ear, nose, and throat (ENT) surgery.
Patients will preoperatively gurgle a suspension of probiotics and then swallow the preparation.
Postoperatively the probiotics is given enterally and a eventually by mouth again.
Cultures will be taken from the oropharynx and tracheal secretions and the results will be compared
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
Longer surgical procedures require intubation and there is a potential risk of contaminating the lower airways with pathogenic bacteria from the mouth and oropharynx.
Surgery including the mouth and the oropharynx is performed in an area that is colonised by hundreds of different bacterial species. In the healthy person there is a balance between the different microbes and possible pathogens are kept under control.
Patients that are subject to surgery in the mouth, oropharynx or neck area, most often have cancer diagnoses. Preoperative treatment (mostly radiation) is done in most cases resulting in a changed spectrum of bacteria in the mouth and oropharynx. Due to lowered appetite increased difficulties to eat, in combination with cancer diagnosis, there is also a change in cranial direction of the microbiological gut flora resulting in the presence of pathogens such as Gram-negative bacteria. Those species may result in troublesome infections in the postoperative period.
With healthy people pathogenic bacteria originating from the gastro/intestinal canal are seldom found in the oropharynx, but those do occur among many patients.
Antibiotics are used prophylactic and for more extensive surgery, as micro vascular procedures with free transplants of tissues, antibiotics are kept throughout the length of stay (LOS) in hospital. This results in an increased risk for the development of resistant bacteria and does result in changes in the GI flora in those patients. Diarrhoea occurs frequently and are troublesome for the patients For ICU patients we have seen a reduction of emerging enteric bacteria in patients given oral care with probiotics and this study will explore the possibility of the same kind of positive effects in patients due for extensive surgery performed during several hours.
Many of the patients will have a tracheostomy performed as part of the surgical procedure.
Patients will be randomised (1:1) to either no prophylaxis (standard procedure today) or to preparation with a probiotic suspension fro the day before surgery until discharge from hospital.
Preoperatively the patients will gurgle a suspension of probiotics and then swallow the preparation.
Postoperatively the probiotics is given enterally and a eventually when the responsible surgeon find it suitable by mouth again.
Cultures at inclusion, after intubation, and then on predefined days postoperatively to compare bacterial flora in the oropharynx and in tracheal secretions.
Infectious parameters will be followed.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
-
Lund, Svezia, SE 22185
- Lund University Hospital
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Elective advanced and extensive ENT surgery
- Adult patients (≥ 18 years)
- Surgery requires general anesthesia and endotracheal intubation
- Length of anesthesia ≥ 1,5 hours
- Signed informed consent
Exclusion Criteria:
- Ongoing treatment requiring infection in the lower respiratory tract
- Chronic lung disease requiring oxygen treatment
- Known immune deficiency
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: Probiotics
Patients will gurgle and swallow a mixture of probiotic bacteria preoperatively and given the same study product enterally postoperatively
|
Patients will be given a mixture of maltodextrin ( a starch product often used i alimentary products) and two strains of probiotic bacteria ( L. plantarum 299 and L. plantarum 299v ) dissolved in water. They will gurgle and swallow the suspension from the day before surgery. Postoperatively they will be given the probiotic mixture via a nasogastric tubing twice a day and when the responsible surgeon find it suitable also orally as described above. When they can swallow no study product is given through the nasogastric tube. Patients randomized 1:1 between groups |
Nessun intervento: Control
No intervention.What has been the standard procedure so far
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Differences in pathogenic bacteria in the oropharynx
Lasso di tempo: During hospitalization, anticipated mean time 12 days
|
Emerging and resident bacteria will be compared for the cultures taken in the oropharynx and from tracheal secretions in connection to a surgical intervention and postoperatively
|
During hospitalization, anticipated mean time 12 days
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Sopravvivenza
Lasso di tempo: Sei mesi
|
Per i pazienti partecipanti verrà registrato lo stato di sopravvivenza o non sopravvivenza ai giorni 28 e 180 (sei mesi)
|
Sei mesi
|
White Blood Cell count
Lasso di tempo: During hospital stay, expected mean LOS 12 days
|
WBC taken pre-op and then on predefined days postoperatively
|
During hospital stay, expected mean LOS 12 days
|
C Reactive Protein
Lasso di tempo: Throughout the hospital stay, expected mean LOS 12 days
|
CRP taken pre-op and then on predefined days postoperatively
|
Throughout the hospital stay, expected mean LOS 12 days
|
Length of Hospital stay
Lasso di tempo: Participants will be followed for the duration of hospital stay, an expected average of 2-3 weeks
|
Length of stay is recorded for the Hospital stay, and for those cases that have an extended post-operative period in the ICU, the length of the ICU stay will be recorded
|
Participants will be followed for the duration of hospital stay, an expected average of 2-3 weeks
|
Diarrhoea and obstipation
Lasso di tempo: Throughout the hospital stay, expected mean LOS 12 days
|
As ICU patients tend to display diarrhoea as well as obstipation the frequency and consistency of stools will be recorded. Probiotics are anticipated to stabilise bowel function |
Throughout the hospital stay, expected mean LOS 12 days
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Bengt Klarin, MD, PhD, Lund University Hospital
Pubblicazioni e link utili
Pubblicazioni generali
- Stjernquist-Desatnik A, Warfving H, Johansson ML. Persistence of Lactobacillus plantarum DSM 9843 on human tonsillar surface after oral administration in fermented oatmeal gruel. A pilot study. Acta Otolaryngol Suppl. 2000;543:215-9. doi: 10.1080/000164800454422.
- Klarin B, Molin G, Jeppsson B, Larsson A. Use of the probiotic Lactobacillus plantarum 299 to reduce pathogenic bacteria in the oropharynx of intubated patients: a randomised controlled open pilot study. Crit Care. 2008;12(6):R136. doi: 10.1186/cc7109. Epub 2008 Nov 6.
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- ProOncENT
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Advanced ENT Surgery
-
Rush University Medical CenterCompletatoAdvanced Cardiac Life Support, rianimazione cardiopolmonare, volume corrente, ventilazione manualeStati Uniti
-
Assistance Publique - Hôpitaux de ParisCompletatoIdoneo per Day Case SurgeryFrancia
-
The Leeds Teaching Hospitals NHS TrustAttivo, non reclutanteFerite e lesioni | Chirurgia | Riabilitazione | Disturbo ortopedico | Misure di esito riferite dal paziente | Valutazione della disabilità | Recupero della funzione | Trauma multiplo/lesioni | Centri traumatologici | Indici di gravità del trauma | Advanced Trauma Life Support CareRegno Unito
-
Advanced BionicsCompletatoPerdita dell'udito da grave a profonda | negli utenti adulti di Advanced Bionics HiResolution™ Bionic Ear SystemStati Uniti
Prove cliniche su L. plantarum 299 and L. plantarum 299v (+maltodextrin)
-
Region SkaneLund UniversityTerminatoProbiotici per la riduzione delle infezioni da Clostridium Difficile nei pazienti critici (ProbiEnt)Clostridium Difficile Colonizzazione | Impatto dei probiotici enterali su determinati parametri di laboratorioSvezia
-
Region SkaneLund UniversityCompletatoMicrobiologia orofaringeaSvezia
-
Children's Oncology GroupNational Cancer Institute (NCI)Attivo, non reclutanteLinfoma | Leucemia | Neoplasie del sistema ematopoietico e linfoideStati Uniti, Canada
-
Columbia UniversityNemours Children's Clinic; Johns Hopkins All Children's HospitalCompletatoOrgani emopoietici; DisturboStati Uniti
-
University of CopenhagenThe Ministry of Science, Technology and Innovation, DenmarkCompletatoNegozi di ferro bassoDanimarca
-
Region SkaneProbi ABCompletato
-
Medical University of GdanskCompletato
-
Medical College of WisconsinAdvancing a Healthier WisconsinReclutamentoArresto cardiaco | Insufficienza cardiaca, diastolica | Insufficienza cardiaca, sistolica | Insufficienza cardiaca con frazione di eiezione ridotta | Insufficienza cardiaca con frazione di eiezione conservataStati Uniti
-
Medical College of WisconsinReclutamento
-
Medical College of WisconsinReclutamento