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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Penicillin G | No Intervention | hospitalization of 30 patients given penicilline intraveniously for 72 hours | |
| Placebo | Placebo Comparator | 30 hospitalized patients will be given placebo with a regular penicillin treatment |
|
| Probiotic | Experimental | Probiotics will be given to 30 hospitalized patients with regular penicillin treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | 1 tablet 2 times daily |
|
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leonid Livshits, MD | Ziv Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ziv Medical Center | Safed | Israel |
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| ID | Term |
|---|---|
| D010612 | Pharyngitis |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D000073893 | Sugars |
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D002241 | Carbohydrates |
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
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| Probiotics | Drug | 1 tablet twice daily |
|
|
| 10 days |
| D012140 |
| Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D010829 |
| Physiological Phenomena |
| D019602 | Food and Beverages |