L. Reuteri ATCC PTA 5289 & L. Reuteri DSM 17938 for the Treatment of Children With Pharyngitis and/or Tonsillitis
Condition: Pharyngitis; Tonsillitis
MeSH terms: Pharyngitis; Tonsillitis
Study type: Interventional

Summary: 
      RCT in children (6m to 5y) with pharyngitis and/or tonsillitis who will be allocated to
      receive for 10 days L. reuteri DSM 17938 + L. reuteri ATCC PTA 5289) at a dose of 2x10^8
      Colony Forming Units (CFU). Five drops are to be taken twice a day (in the morning and in the
      evening) or placebo drops, as treatment for clinical condition. Duration of symptoms and
      reduction of pain (odynophagia) severity during treatment will be measured as primary outcome
    

Detailed description: 
      Rationale. Acute respiratory infections (ARIs) are a common problem in the first decade of
      life. The yearly prevalence of respiratory tract infections in an otherwise healthy 3-year
      old child is about three to 10 infections. Children between 6 months and 5 years are more
      prone to develop pharyngitis and tonsillitis compared to older children. 60-70% of children
      with F/T lies within this age group. Aetiology the pharyngitis and tonsillitis is viral in
      70% of all cases In developing countries 6/10 cases are treated using antibiotics, regardless
      of clinical guidelines or standard of care documents recommending only to use symptomatic
      drugs (NSAID).

      Primary outcome. Duration of symptoms and reduction of pain (odynophagia) severity Secondary
      outcomes. Days with fever secondary to RTIs; Number of children receiving antibiotic
      treatment in each treatment group; Days of medical office visits or emergency visits; Total
      amount of medical office visits or emergency visits during the study, secondary to episodes
      of RTI; Days of absences from day care centre; Direct and Indirect costs Total costs of
      treatments including visit to private office, visit to emergency department, cost of
      treatment (NSAIDs + Probiotics vs NSAIDs + Placebo); Frequency of adverse events;
      Viral/bacterial load (multiplex-PCR); IgA in saliva and Change in salivary inflammatory
      biomarkers.

      Interventions. L. reuteri DSM 17938 + L. reuteri ATCC PTA 5289) will be given at a dose of
      2x10^8 Colony Forming Units (CFU). Five drops are to be taken twice a day (in the morning and
      in the evening) giving a daily dose of 4x108 CFU/day. The placebo drops will have identical
      ingredients except for lacking the bacteria. Five drops are to be taken twice a day (in the
      morning and in the evening).
    

Intervention name(s): Probiotic; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): L. reuteri Prodentis oil drops (L. reuteri DSM 17938 and L. reuteri ATCC PTA 5289) will be given at a dose of 2x108 Colony Forming Units (CFU). Five drops are to be taken twice a day (in the morning and in the evening) giving a daily dose of 4x108 CFU/day.; Five drops of Placebo taken twice a day (in the morning and in the evening).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial, double blind allocation concealment, parallel assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment