Text Size

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

This study is not yet open for participant recruitment.
Verified November 2011 by Ziv Hospital
Sponsor:
Information provided by (Responsible Party):
Ziv Hospital
ClinicalTrials.gov Identifier:
NCT01679366
First received: August 16, 2012
Last updated: October 23, 2012
Last verified: November 2011
History of Changes
  Purpose

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 Intervention Phase
Throat Pain
 Drug: Placebo
Drug: Probiotics
 Phase 3

Study Type: Interventional
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

Further study details as provided by Ziv Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 90
Study Start Date: October 2012
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01679366

Contacts
Contact: Leonid Livshits, MD +972506266061 leonid.lv@ziv.health.gov.il
Contact: Dan Miron, Proff +972508434337 miron_da@clalit.org.il

Locations
Israel
Ziv Medical Center Not yet recruiting
Safed, Israel
Contact: Leonid Livshits, MD     +972506266061     leonid.lv@ziv.health.gov.il    
Contact: Dan Miron, Proff     +972508434337     miron_da@clalit.org.il    
Sponsors and Collaborators
Ziv Hospital
Investigators
Principal Investigator: Leonid Livshits, MD Ziv Medical center
  More Information

No publications provided

Responsible Party: Ziv Hospital
ClinicalTrials.gov Identifier: NCT01679366     History of Changes
Other Study ID Numbers: 0054-11-ZIV
Study First Received: August 16, 2012
Last Updated: October 23, 2012
Health Authority: Israel: Ministry of Health

ClinicalTrials.gov processed this record on May 23, 2013