Use of Probiotics as Adjunctive Treatment for Chronic Rhinosinusitis
Condition: Chronic Rhinosinusitis
MeSH terms: Sinusitis
Intervention: probiotic containing L.rhamnosus R0011 strain; Placebo
Intervention description: 500 million active cells of L rhamnosus R0011 strain per tablet bid for 4 weeks; Placebo pill
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 77.0
Sex: All
Minimum age: 15 Years
Maximum age: 70 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age ≥15 and ≤70 years.

          2. The patient must be bothered by each of the two following symptoms(>50% of days in the
             last 3 months):

             A. More than 12 consecutive weeks of symptomatic nasal obstruction and, B. More than
             12 weeks of symptomatic nasal discharge.

          3. An Otolaryngologist evaluation and diagnosis of chronic inflammatory rhinosinusitis
             (hyperplastic mucosa, polyps in absence of overt bacterial infection)

          4. Access to telephone (home or person cell).

        Exclusion Criteria:

          1. Sinus surgery within the last 3 months

          2. Acute illness within the last 2 weeks requiring antibiotics: including: otitis media,
             pharyngitis, bronchitis, or laryngitis.

          3. Immunosuppression (due to medications including oral steroids, or due to autoimmune
             diseases, HIV infection, cystic fibrosis, immunodeficiency, malignancies, uncontrolled
             diabetes mellitus, chronic renal failure, etc.)

          4. Patients with chronic or acute bacterial sinusitis.(Clinical diagnosis-to be decided
             by MD)

          5. An allergic reaction to a probiotic dietary supplement in the past (such as symptoms
             of tightness in the chest, breathing difficulties, skin hives, rash or other clinical
             symptoms consistent with sensitivity or intolerance)

          6. Inability to speak or read English.

          7. Pregnancy and Lactation