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

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.

Study Overview

• Status: Completed
• Conditions: Throat Pain
• Intervention / Treatment: Drug: Placebo; Drug: Probiotics

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.

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Phase 3

Contacts and Locations

Study Locations

• Israel
  • Safed, Israel
    • Ziv Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: 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 Names: BLIS

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ziv Hospital
• Investigators: Principal Investigator: Leonid Livshits, MD, Ziv Medical Center

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (ACTUAL): September 1, 2013
• Study Completion (ACTUAL): October 1, 2013

Study Registration Dates

• First Submitted: August 16, 2012
• First Submitted That Met QC Criteria: September 2, 2012
• First Posted (ESTIMATE): September 6, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): October 22, 2014
• Last Update Submitted That Met QC Criteria: October 21, 2014
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Other Study ID Numbers: 0054-11-ZIV