The Effectiveness of Probiotics for the Therapy of Acute Pharyngotonsillitis in Adult Patients
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||The Effectiveness of Probiotics for the Therapy of Acute Pharyngotonsillitis in Adult Patients|
- period of disease [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]Patients will be followed daily while hospitalized. After discharge patients will fill a daily dairy for 10 days and record symptoms, signs, drinking, eating, and return to normal life. All dairies will be collected on day 10 of the study.
- analysis [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]Follow-up throat culture, CBC, CRP, and ESR on day 4 of the study or at discharge if before. For patients with abnormal laboratory tests on admission, repeat tests are performed before discharge according to the routine of the department. For patients with normal tests on admission, these tests will be part of the study. For patients with Streptococcus pyogenes growth on admission and day 4 of the study, another throat culture will be done on day 10 of the study
|Study Start Date:||October 2012|
|Study Completion Date:||October 2013|
|Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
No Intervention: Penicillin G
hospitalization of 30 patients given penicilline intraveniously for 72 hours
Placebo Comparator: Placebo
30 hospitalized patients will be given placebo with a regular penicillin treatment
1 tablet 2 times daily
Other Name: Sugar pill for mimic probiotics
Probiotics will be given to 30 hospitalized patients with regular penicillin treatment
1 tablet twice daily
Other Name: BLIS
Hypothesis The addition of probiotics to the routine therapy of AP in adult patients may shorten the duration, and reduce the severity of the disease.
Study design A prospective, randomized, placebo-controlled, double-blinded study comparing treatment with probiotics to placebo in patients with AP.
The study will be conducted in accordance with the ethical standards of the Helsinki Declaration and will be approved by the Human Experimentation Ethics Committee of the Ziv Medical Center. Signed informed consent will be required from all patients before inclusion.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01679366
|Ziv Medical Center|
|Principal Investigator:||Leonid Livshits, MD||Ziv Medical Center|