Use of Probiotics as Adjunctive Treatment for Chronic Rhinosinusitis

This study has been completed.
Sponsor:
Collaborator:
Institut Rosell
Information provided by (Responsible Party):
Jeffrey E. Terrell, M.D., University of Michigan
ClinicalTrials.gov Identifier:
NCT00396162
First received: November 2, 2006
Last updated: June 12, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Chronic Rhinosinusitis
Drug: probiotic containing L.rhamnosus R0011 strain
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • The specific aims of the study are to determine: 1) if oral probiotics as adjunctive treatment results in improvement in disease-specific quality of life as measured by change in 20-item Sino-Nasal Outcome Test (SNOT-20) scores and [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    SNOT-20 disease specific Qol outcomes measures were used. See publication.

  • 2) oral probiotics as compared with placebo result in greater improvement in disease-specific quality of life as measured by change in SNOT-20 scores. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Disease specific QOL as measured by the SNOT 20 instrument.


Secondary Outcome Measures:
  • To determine if regular use of probiotics may decrease medication usage in patients with chronic rhinosinusitis. Also, to determine the side-effect profile and compliance rate. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Side effects, compliance, and secondary medication usage.


Enrollment: 77
Study Start Date: November 2006
Study Completion Date: February 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo pill
Placebo pills on same schedule as active intervention.
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
Active Comparator: Probiotic
drug
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

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.

  Eligibility

Ages Eligible for Study:   15 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00396162

Sponsors and Collaborators
University of Michigan
Institut Rosell
Investigators
Principal Investigator: Jeffrey E Terrell, MD University of Michigan
  More Information

No publications provided

Responsible Party: Jeffrey E. Terrell, M.D., Professor of Otolaryngology, University of Michigan
ClinicalTrials.gov Identifier: NCT00396162     History of Changes
Other Study ID Numbers: HUM00006212
Study First Received: November 2, 2006
Last Updated: June 12, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on April 17, 2014