The Effectiveness of Probiotics for the Therapy of Acute Pharyngotonsillitis in Adult Patients

Study Overview
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Brief Summary
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The addition of probiotics to the routine therapy of Acute Pharyngotonsillitis in adult patients may shorten the duration, and reduce the severity of the disease.

Detailed Description
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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.

Official Title
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The Effectiveness of Probiotics for the Therapy of Acute Pharyngotonsillitis in Adult Patients

Conditions
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Throat Pain

Intervention / Treatment
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* Drug: Placebo
* Drug: Probiotics


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age over 18 years Acute pharyngotonsillitis for which hospitalization for intravenous antibiotic treatment and/or fluids is needed Exclusion Criteria: Current therapy with systemic prednisone or equivalent at 20 mg/d for more than 10 days prior to inclusion

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Penicillin G<br>hospitalization of 30 patients given penicilline intraveniously for 72 hours | |
| Placebo Comparator: Placebo<br>30 hospitalized patients will be given placebo with a regular penicillin treatment | Drug: Placebo<br>* 1 tablet 2 times daily<br>* Other names: Sugar pill for mimic probiotics;|
| Experimental: Probiotic<br>Probiotics will be given to 30 hospitalized patients with regular penicillin treatment | Drug: Probiotics<br>* 1 tablet twice daily<br>* Other names: BLIS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| period of disease | 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. | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| analysis | 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 | 10 days |