Use of Probiotics as Adjunctive Treatment for Chronic Rhinosinusitis

Chronic Rhinosinusitis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00396162
• Other study ID #: HUM00006212
• Status: Completed
• Phase: Phase 4
• First received: November 2, 2006
• Last updated: June 12, 2012
• Start date: November 2006
• Est. completion date: February 2008

Study information

• Verified date: June 2012
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: February 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 70 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Chronic Rhinosinusitis
• Sinusitis

Intervention

Drug:
• probiotic containing L.rhamnosus R0011 strain
500 million active cells of L rhamnosus R0011 strain per tablet bid for 4 weeks

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Institut Rosell

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	SNOT-20 disease specific Qol outcomes measures were used. See publication.	8 weeks	No
Primary	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.	Disease specific QOL as measured by the SNOT 20 instrument.	8 weeks	No
Secondary	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.	Side effects, compliance, and secondary medication usage.	8 weeks	No