Phase 4
N=77
Use of Probiotics as Adjunctive Treatment for Chronic Rhinosinusitis
Chronic Rhinosinusitis
Bottom Line
View on ClinicalTrials.gov: NCT00396162 ↗Enrolled (actual)
77
Serious AEs
0.0%
Results posted
Aug 2016
Primary outcome: Primary: Mean Reduction in SNOT-20 Scores — 1.8; 5.5 units on a scale — p=0.23
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- probiotic containing L.rhamnosus R0011 strain (Drug); Placebo (Other)
- Age
- Pediatric, Adult, Older Adult · 15+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Jan 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Reduction in SNOT-20 Scores |
1.8; 5.5 | 0.23 |
| SECONDARY Side Effect Summary |
17; 14 | .31 |
| SECONDARY Mean Number of Days of Antibiotic Use During the Study Period (0-8 Weeks) |
1.9; 0.8 | — |
| SECONDARY Mean Number of Days of Steroid Spray Use for Each Group |
2.8; 0.4 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Age ≥15 and ≤70 years.
- 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.
- An Otolaryngologist evaluation and diagnosis of chronic inflammatory rhinosinusitis (hyperplastic mucosa, polyps in absence of overt bacterial infection)
- Access to telephone (home or person cell).
Exclusion Criteria
- Sinus surgery within the last 3 months
- Acute illness within the last 2 weeks requiring antibiotics: including: otitis media, pharyngitis, bronchitis, or laryngitis.
- 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.)
- Patients with chronic or acute bacterial sinusitis.(Clinical diagnosis-to be decided by MD)
- 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)
- Inability to speak or read English.
- Pregnancy and Lactation
Data sourced from ClinicalTrials.gov (NCT00396162). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.