Use of Probiotics as Adjunctive Treatment for Chronic Rhinosinusitis
Condition: Chronic Rhinosinusitis
MeSH terms: Sinusitis
Study type: Interventional
Phase: Phase 4

Summary: 
      Chronic sinusitis is reported to be one of the most widespread disorders in the United
      States. It can be caused by a variety of reasons such as allergy, infection and/or defects in
      T-cells which help regulate immune function. Medication and other costs related to treatment
      of nasal and sinus infections are estimated to be more than $60 million annually putting a
      considerable strain on the economy of health care.

      Probiotics are live microorganisms that are normally present in the gut of a healthy
      individual. They are also known as "friendly bacteria" and have been used to help maintain
      the normal functioning of the immune system. They are safe and are commercially available in
      the form of yoghurt, sachets, chewable tablets or flavored capsules. Since a number of nasal
      and sinus disorders are related to allergy and improper functioning of the immune system, we
      hypothesize that regular use of probiotics may help improve chronic nasal and sinus symptoms
      by boosting immune responses.

      The project we propose is novel because it would be the first study evaluating the usefulness
      of probiotics for the larger population having chronic sinusitis rather than those having
      only allergic symptoms. We aim to assess whether regular use of probiotics will help improve
      symptoms of chronic sinusitis and will have a greater effect than placebo in this regard.
    

Detailed description: 
      Probiotics are live microorganisms which when administered in adequate amounts confer a
      health benefit on the host. They are a part of the normal gastrointestinal flora and have
      safely been used to boost immune responses in patients with perennial and seasonal allergic
      rhinitis. Their exact mechanism of benefit is unknown but they primarily help to regulate
      T-cell function which is important in maintaining immune tolerance.

      Chronic rhinosinusitis is widely prevalent and affects nearly 16 million people in the US
      alone each year. It puts a strain on the health resources of the nation in terms of costs
      related to medications and surgery. Chronic rhinosinusitis can be caused by a variety of
      reasons including allergy/hypersensitivity, infection, nasal anatomical variations and T-cell
      regulatory dysfunction. We hypothesize that regular use of probiotics in patients with
      chronic rhinosinusitis will result in substantial improvement in their symptoms by boosting
      their immunity and may also help decrease their medication usage.

      Our study will be a double-blinded, randomized, control trial. We hope to recruit 100
      patients from the University Otolaryngology and Allergy Clinics. Fifty patients will be
      randomized to the treatment (active) arm and 50 patients to the placebo arm. Subjects will be
      followed for 2 months during their period of participation in the study.

      The main aim of our study is to determine whether regular use of probiotics in patients with
      chronic rhinosinusitis helps improve their quality of life. Our main outcome of interest is a
      change in the mean score of the Sino-Nasal Outcome Test (SNOT-20) form in the treatment group
      and a greater change in the mean score of the SNOT-20 in the treatment arm as compared to the
      placebo arm. If probiotics are found to be effective, they may be used as a cost-effective,
      adjunctive therapy for patients with chronic rhinosinusitis.
    

Intervention name(s): probiotic containing L.rhamnosus R0011 strain; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 500 million active cells of L rhamnosus R0011 strain per tablet bid for 4 weeks; Placebo pill
Other intervention name(s): L rhamnosus R0011
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment