Can Probiotic Vivomixx Eradicate Colonization With ESBL?
Condition: Antibiotic Resistant Infection
Study type: Interventional

Summary: 
      Can probiotic Vivomixx eradicate Extended Spectrum BetaLactam (ESBL) colonization in adult
      patients?
    

Detailed description: 
      Infections due to extended spectrum cephalosporin-resistant Enterobacteriaceae (ESCRE) are a
      widely recognized public health threat. The prevalence of ESCRE is comparably low in Sweden
      but is steadily increasing; approximately 5 % of Swedish inhabitants are carrying ESCRE in
      the gut. ESCRE can lead to infections mainly from urine, abdomen and blood. These infections
      can be problematic to treat with current available antibiotics and represent a clinical
      challenge for clinicians around the world with considerable mortality and morbidity. Risk
      factors for acquiring an ESCRE is e.g. antibiotic treatment, trips to high prevalence
      countries, family member with ESCRE etc.

      The duration of ESCRE carriage is not known. One Swedish study showed that ESCRE carriage can
      continue despite antibiotic treatment and that false negative cultures in between positive
      cultures are common. Since few new groups of antibiotics have been developed in the last
      decades, infections due to ESCRE may be increasingly difficult to treat. The possibility of
      ESCRE decolonization is therefore a desirable aim, in particular the more virulent
      enterobacteriaceae strains leading to recurrent clinical infection episodes.

      Probiotics are microorganisms marketed as useful bacteria effective locally in the gut. In
      recent years many studies have focused on potential health benefits in a range of different
      gastrointestinal diseases e.g. ulcerous colitis, Crohn's disease, antibiotic associated
      diarrhoea where probiotics potentially have a therapeutic role4. Smaller studies have shown
      that probiotics possibly can bind and eliminate enteric pathogenic bacteria5-6. A small in
      vitro study showed that probiotics can be effective against antibiotic resistant bacteria.
      Larger clinical treatment studies are needed.

      ESCRE constitutes a clinical problem and is largely seen in Escherichia coli and klebsiella
      spp. The investigator's theory is that the probiotic Vivomixx can reject ESCRE and thus
      decolonize the gut. Vivomixx contains eight different strains of probiotics; Bifidobacterium
      breve, B. longum, B. infantis, Lactobacillus acidophilus, L. plantarum, L. paracasei, L.
      bulgaricus, Streptococcus thermophilus and has the best documentation in clinical studies for
      enteric diseases of today.
    

Intervention name(s): Vivomixx; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Two months of 2 sachets vivomixx each morning and 2 sachets each night. Each sachet of viviomixx contains 450 billion live bacteria.; Two months of 2 sachets placebo each morning and 2 sachets each night. Each sachet of placebo contains 450 billion live bacteria.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment