A placebo-controlled, randomized, double-blind study to assess the efficacy of a specific probiotic formulation in the reduction of recurrent respiratory tract infections (RTIs) and antibiotic prescriptions
- Conditions
- recurrent respiratory tract infectionsICD-10: J00-J22
- Registration Number
- DRKS00017688
- Lead Sponsor
- Microbiotica GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 354
• Age 18 and older
• Patients starting antibiotic treatment (oral or i.v.) for any cause for not more than 14 days
• Patients with a history of 2-4 episodes of RTI during the last 12 months before inclusion
• Patients with a history of 1-4 antibiotic therapies (oral or i.v.) for any cause during the last 12 months before inclusion
• Patients able to understand and follow study procedures
• Signed Informed Consent Form
• Acute and chronic diarrhea at inclusion
• People who never had a flu vaccination before, but had one for the period covering the study duration (autumn/winter 2019/2020) or are planning a vaccination for this period.
• Intake of probiotic supplements and/or medications 4 weeks prior and/or during the study
• Severe COPD (GOLD grade IV or group D)
• Severe asthma (eosinophilic or asthma, treated with monoclonal antibodies)
• Immunodeficiency (e.g. HIV, chemo-, radio- , immune therapy) in the last 12 months or during the study
• Long term use of immune suppressant or immune stimulating prescription medication (e.g. interferon, growth factor, monoclonal antibodies, etc.)
• Subjects presenting with an active, non-controlled intestinal disease such as Crohn’s disease or ulcerative colitis
• A previous documented C. difficile infection <3 months prior to study initiation
• Severe organ or systemic disease which will influence the conduct of the study based on the physician´s assessment as well as any health condition that will not allow to follow study procedures or compliance
• Alcohol addiction or abuse
• Drug addiction or abuse
• Known hypersensitivity to the any ingredient of the study product
• Current participation in another clinical trial or participation in another clinical trial within the last 30 days
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The number of RTI* episodes after 3 and 6 months will be evaluated separately in sequential order,<br>• First, testing the number of RTI episodes after 3 months<br>• Secondly, testing the number of RTI episodes after 6 months <br>• Because the tests are to be performed in sequential order, meaning the subsequent test will be considered as confirmatory test only, when the previous test was shown significant, no adjustment for the type-I error rate is needed. Consequently, if the first test is not significant, the second test can only be considered as descriptive test.<br><br>* RTI and the antibiotic prescription at study entry will not be considered for the endpoints.
- Secondary Outcome Measures
Name Time Method • Number of RTI* episodes from month 3 until end of trial <br>• Total days of RTI* <br>• Severity of RTI* <br>• Symptoms of RTI*<br>• Percentage of patients with at least 1 RTI* <br>• Percentage of patients with 2 and more RTIs* <br>• Number of days with AAD<br>• Number of days with loose / watery stools in association with antibiotic treatment<br>• Abdominal symptoms in association with antibiotic treatment <br>• Severity of abdominal symptoms in association with antibiotic treatment<br>• Number of antibiotic prescriptions for RTI* / any cause<br>• Number of visits for RTI / gastrointestinal complaints in addition to the regular study visits <br>• Absent days from work or school / university because of RTI* / abdominal symptoms<br>• Subjective evaluation of tolerability, efficacy, future use<br><br>* RTI and the antibiotic prescription at study entry will not be considered for the endpoints.