Use of Probiotics as Adjunctive Treatment for Chronic Rhinosinusitis

NCT00396162 | Completed Phase 4 Results

• 1 other identifier: HUM00006212
• Study Type: interventional
• Target: 77
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Rhinosinusitis

Outcome Measures

Primary Outcomes (1)

• Mean Reduction in SNOT-20 Scores

  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.

  8 weeks

Secondary Outcomes (3)

• Side Effect Summary

  8 weeks

• Mean Number of Days of Antibiotic Use During the Study Period (0-8 Weeks)

  At 8 weeks after baseline measures

• Mean Number of Days of Steroid Spray Use for Each Group

  8 weeks

Study Arms (2)

Placebo pill

PLACEBO COMPARATOR

Placebo pills on same schedule as active intervention.

Other: Placebo

Probiotic

ACTIVE COMPARATOR

L. rhamnosus R0011 strain

Drug: probiotic containing L.rhamnosus R0011 strain

Interventions

probiotic containing L.rhamnosus R0011 strain DRUG

500 million active cells of L rhamnosus R0011 strain per tablet bid for 4 weeks

Also known as: L rhamnosus R0011

Probiotic

Placebo OTHER

Placebo pill

Placebo pill

Eligibility Criteria

• Age: 15 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• Institut Rosell: collaborator

Results Point of Contact

• Title: Jeffrey E. Terrell
• Organization: University of Michigan

terrelj@umich.edu

734 936 7633

Study Officials

• Jeffrey E Terrell, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Otolaryngology

Study Record Dates

• First Submitted: November 2, 2006
• First Posted: November 6, 2006
• Study Start: November 1, 2006
• Primary Completion: January 1, 2008
• Study Completion: February 1, 2008
• Last Updated: September 20, 2016
• Results First Posted: August 4, 2016

Record last verified: 2016-08