Use of Probiotics as Adjunctive Treatment for Chronic Rhinosinusitis
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.
Drug: probiotic containing L.rhamnosus R0011 strain
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Use of Probiotics as Adjunctive Treatment for Chronic Rhinosinusitis|
- Mean Reduction in SNOT-20 Scores [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Mean reduction (and Standard deviation) in SNOT-20 scores, from baseline to 8 week measurements. SinoNasal Outcome Test measures symptom severity. It is a summary score, ranging from 0 to 100 with 100 indicating worse symptoms. Since 100 represents more severe symptoms, the changes represented here are reductions in SNOT-scores, even though they are not expressed as negative numbers.
- Side Effect Summary [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Totals of all side effects for placebo group and treatment group over the course of the eight week trial (including patients who dropped from the study after baseline measurement). Individual categories of side-effects are listed in Adverse events section.
- Mean Number of Days of Antibiotic Use During the Study Period (0-8 Weeks) [ Time Frame: At 8 weeks after baseline measures ] [ Designated as safety issue: No ]Mean number of days that antibiotics were used in the subgroup (placebo vs Probiotic arm)
- Mean Number of Days of Steroid Spray Use for Each Group [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||November 2006|
|Study Completion Date:||February 2008|
|Primary Completion Date:||January 2008 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo pill
Placebo pills on same schedule as active intervention.
Active Comparator: Probiotic
L. rhamnosus R0011 strain
Drug: probiotic containing L.rhamnosus R0011 strain
500 million active cells of L rhamnosus R0011 strain per tablet bid for 4 weeks
Other Name: L rhamnosus R0011
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00396162
|Principal Investigator:||Jeffrey E Terrell, MD||University of Michigan|