- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus 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
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
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Lund, Ruotsi, SE 22185
- Lund University Hospital
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Ennaltaehkäisy
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Kokeellinen: Probiotics
Patients will gurgle and swallow a mixture of probiotic bacteria preoperatively and given the same study product enterally postoperatively
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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 |
Ei väliintuloa: Control
No intervention.What has been the standard procedure so far
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
Differences in pathogenic bacteria in the oropharynx
Aikaikkuna: During hospitalization, anticipated mean time 12 days
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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
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During hospitalization, anticipated mean time 12 days
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
Eloonjääminen
Aikaikkuna: Kuusi kuukautta
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Osallistuvien potilaiden eloonjäämisen tai eloonjäämisen tila päivinä 28 ja 180 (kuusi kuukautta) kirjataan
|
Kuusi kuukautta
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White Blood Cell count
Aikaikkuna: During hospital stay, expected mean LOS 12 days
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WBC taken pre-op and then on predefined days postoperatively
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During hospital stay, expected mean LOS 12 days
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C Reactive Protein
Aikaikkuna: Throughout the hospital stay, expected mean LOS 12 days
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CRP taken pre-op and then on predefined days postoperatively
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Throughout the hospital stay, expected mean LOS 12 days
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Length of Hospital stay
Aikaikkuna: Participants will be followed for the duration of hospital stay, an expected average of 2-3 weeks
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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
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Participants will be followed for the duration of hospital stay, an expected average of 2-3 weeks
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Diarrhoea and obstipation
Aikaikkuna: Throughout the hospital stay, expected mean LOS 12 days
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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
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Yhteistyökumppanit ja tutkijat
Sponsori
Yhteistyökumppanit
Tutkijat
- Päätutkija: Bengt Klarin, MD, PhD, Lund University Hospital
Julkaisuja ja hyödyllisiä linkkejä
Yleiset julkaisut
- 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.
Hyödyllisiä linkkejä
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Arvio)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muut tutkimustunnusnumerot
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Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
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