NCT02303301

Brief Summary

Hospitalised patients have in contrast to healthy people enteric pathogenic bacteria in their oropharynx Increased risk of pneumonia due to the pathogens in the oropharynx Probiotics can reduce such bacteria in intubated critically ill patients This study will use two strain of probiotic bacteria for half of the patients and a placebo for the rest Active arm gurgles with a suspension twice a day Cultures at inclusion and at set time intervals The results of cultures from the two groups will be compared as will the use of antibiotics

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
145

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 27, 2014

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

October 8, 2020

Status Verified

October 1, 2020

Enrollment Period

4.4 years

First QC Date

November 25, 2014

Last Update Submit

October 6, 2020

Conditions

Pharyngeal Bacterial ColonizationPneumonia

Outcome Measures

Primary Outcomes (1)

  • New appearing pathogenic bacteria in the oropharynx

    Oropharyngeal cultures taken at admission and at specified days thereafter in all patients Results from Clin Microbiology assessed and all relevant findings will be treated according to patterns of antibiotic resistance

    During hospital stay, Average 7 days

Secondary Outcomes (2)

  • Pneumonia

    During hospital stay, Average 7 days

  • Length of hospital stay

    During hospital stay, Average 7 days

Study Arms (2)

Probiotics

ACTIVE COMPARATOR

Patients gurgle twice a day with a suspension of two probiotic strains of bacteria- Contains also a filling material - maltodextrin

Dietary Supplement: Probiotics

Control

PLACEBO COMPARATOR

Patients gurgle twice a day with a suspension of the filling material - maltodextrin

Dietary Supplement: Placebo

Interventions

ProbioticsDIETARY_SUPPLEMENT

Cultures from the oropharynx

Also known as: ProViva (Lactobacillus plantarum 299v)
Probiotics
PlaceboDIETARY_SUPPLEMENT

Cultures from the oropharynx

Also known as: Maltodextrin
Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Admitted to hospital
  • Anticipated length of hospital stay 3 days or more

You may not qualify if:

  • Immune insufficiency
  • Prior participation in the study
  • Not being able to understand study information

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lund University Hospital

Lund, SE-22185, Sweden

Location

Related Publications (3)

  • Johanson WG, Pierce AK, Sanford JP. Changing pharyngeal bacterial flora of hospitalized patients. Emergence of gram-negative bacilli. N Engl J Med. 1969 Nov 20;281(21):1137-40. doi: 10.1056/NEJM196911202812101. No abstract available.

    PMID: 4899868BACKGROUND

  • 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.

    PMID: 18990201RESULT

  • Tranberg A, Klarin B, Johansson J, Pahlman LI. Efficacy of Lactiplantibacillus plantarum 299 and 299v against nosocomial oropharyngeal pathogens in vitro and as an oral prophylactic treatment in a randomized, controlled clinical trial. Microbiologyopen. 2021 Jan;10(1):e1151. doi: 10.1002/mbo3.1151. Epub 2020 Dec 22.

    PMID: 33350604DERIVED

Related Links

MeSH Terms

Conditions

Pneumonia

Interventions

Probioticsmaltodextrin

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Bengt Klarin, MD, PhD

    Lund University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD Consultant

Study Record Dates

First Submitted

November 25, 2014

First Posted

November 27, 2014

Study Start

October 1, 2014

Primary Completion

March 1, 2019

Study Completion

July 1, 2020

Last Updated

October 8, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will share

Study results will be published as a scientific article

Locations

SE(1)