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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01679366
Recruitment Status : Completed
First Posted : September 6, 2012
Last Update Posted : October 22, 2014
Sponsor:
Information provided by (Responsible Party):
Ziv Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Throat Pain Drug: Placebo Drug: Probiotics Phase 3

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effectiveness of Probiotics for the Therapy of Acute Pharyngotonsillitis in Adult Patients
Study Start Date : October 2012
Actual Primary Completion Date : September 2013
Actual Study Completion Date : October 2013

Arm Intervention/treatment
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
Drug: Placebo
1 tablet 2 times daily
Other Name: Sugar pill for mimic probiotics

Experimental: Probiotic
Probiotics will be given to 30 hospitalized patients with regular penicillin treatment
Drug: Probiotics
1 tablet twice daily
Other Name: BLIS




Primary Outcome Measures :
  1. period of disease [ Time Frame: 10 days ]
    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.


Secondary Outcome Measures :
  1. analysis [ Time Frame: 10 days ]
    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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01679366


Locations
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Israel
Ziv Medical Center
Safed, Israel
Sponsors and Collaborators
Ziv Hospital
Investigators
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Principal Investigator: Leonid Livshits, MD Ziv Medical Center
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Responsible Party: Ziv Hospital
ClinicalTrials.gov Identifier: NCT01679366    
Other Study ID Numbers: 0054-11-ZIV
First Posted: September 6, 2012    Key Record Dates
Last Update Posted: October 22, 2014
Last Verified: November 2011