Status:
COMPLETED
Use of Probiotics as Adjunctive Treatment for Chronic Rhinosinusitis
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
Institut Rosell
Conditions:
Chronic Rhinosinusitis
Eligibility:
All Genders
15-70 years
Phase:
PHASE4
Brief 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 ...
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 bo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT00396162
Start Date
November 1 2006
End Date
February 1 2008
Last Update
September 20 2016
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