Use of Probiotics as Adjunctive Treatment for Chronic Rhinosinusitis

• ClinicalTrials.gov Identifier: NCT00396162
• Recruitment Status: Completed
• First Posted: November 6, 2006
• Results First Posted: August 4, 2016
• Last Update Posted: September 20, 2016
• Sponsor: University of Michigan
• Collaborator: Institut Rosell
• Information provided by (Responsible Party): Jeffrey E. Terrell, M.D., University of Michigan

Tracking Information

• First Submitted Date: November 2, 2006
• First Posted Date: November 6, 2006
• Results First Submitted Date: May 28, 2015
• Results First Posted Date: August 4, 2016
• Last Update Posted Date: September 20, 2016
• Study Start Date: November 2006
• Actual Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 11, 2016)

Mean Reduction in SNOT-20 Scores [ Time Frame: 8 weeks ]

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.

Original Primary Outcome Measures (submitted: November 2, 2006)

• 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
• 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.

Current Secondary Outcome Measures (submitted: June 23, 2016)

• Side Effect Summary [ Time Frame: 8 weeks ]
  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 ]
  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 ]

• Original Secondary Outcome Measures (submitted: November 2, 2006): 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.
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Use of Probiotics as Adjunctive Treatment for Chronic Rhinosinusitis
• Official Title: Use of Probiotics as Adjunctive Treatment for Chronic Rhinosinusitis

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 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.

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.

• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
• Condition: Chronic Rhinosinusitis

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
• Other: Placebo
  Placebo pill

Study Arms

• Placebo Comparator: Placebo pill
  Placebo pills on same schedule as active intervention.
  Intervention: Other: Placebo
• Active Comparator: Probiotic
  L. rhamnosus R0011 strain
  Intervention: Drug: probiotic containing L.rhamnosus R0011 strain

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 12, 2012): 77
• Original Enrollment: Not Provided
• Actual Study Completion Date: February 2008
• Actual Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 15 Years to 70 Years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT00396162
• Other Study ID Numbers: HUM00006212
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Jeffrey E. Terrell, M.D., University of Michigan
• Original Responsible Party: Not Provided
• Current Study Sponsor: University of Michigan
• Original Study Sponsor: Same as current
• Collaborators: Institut Rosell

Investigators

• Principal Investigator: Jeffrey E Terrell, MD; University of Michigan

• PRS Account: University of Michigan
• Verification Date: August 2016