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

This study has been completed.
Information provided by (Responsible Party):
Ziv Hospital Identifier:
First received: August 16, 2012
Last updated: October 21, 2014
Last verified: November 2011
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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, 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 ]
    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 ]
    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

Enrollment: 57
Study Start Date: October 2012
Study Completion Date: October 2013
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01679366

Ziv Medical Center
Safed, Israel
Sponsors and Collaborators
Ziv Hospital
Principal Investigator: Leonid Livshits, MD Ziv Medical Center
  More Information

Responsible Party: Ziv Hospital Identifier: NCT01679366     History of Changes
Other Study ID Numbers: 0054-11-ZIV
Study First Received: August 16, 2012
Last Updated: October 21, 2014

Additional relevant MeSH terms:
Anti-Bacterial Agents
Anti-Infective Agents processed this record on April 25, 2017