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

Phase 3

Completed

• Conditions: Throat Pain
• Interventions: Drug: Placebo; Drug: Probiotics

• Registration Number: NCT01679366
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2011-11
• Study First Submitted: 2012-08-16
• Study First Submitted QC: 2012-09-02
• Study First Posted: 2012-09-06
• Study Start: 2012-10
• Primary Completion: 2013-09
• Study Completion: 2013-10
• Last Update Submitted: 2014-10-21
• Last Update Posted: 2014-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	30 hospitalized patients will be given placebo with a regular penicillin treatment
Probiotic	Probiotics	Probiotics will be given to 30 hospitalized patients with regular penicillin treatment

Primary Outcome Measures

Name	Time	Method
period of disease	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

Name	Time	Method
analysis	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

Trial Locations

Locations (1)

Ziv Medical Center; 🇮🇱 Safed, Israel