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

Condition(s) targeted: Throat Pain

Intervention: Placebo (Drug); Probiotics (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Ziv Hospital

Official(s) and/or principal investigator(s):
Leonid Livshits, MD, Principal Investigator, Affiliation: Ziv Medical Center

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: period of disease

Secondary outcome: analysis

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Ziv Medical Center, Safed, Israel

Starting date: October 2012
Last updated: October 21, 2014