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

Throat Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01679366
• Other study ID #: 0054-11-ZIV
• Status: Completed
• Phase: Phase 3
• First received: August 16, 2012
• Last updated: October 21, 2014
• Start date: October 2012
• Est. completion date: October 2013

Study information

• Verified date: November 2011
• Source: Ziv Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: October 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Throat Pain

Intervention

Drug:
• Placebo
1 tablet 2 times daily
• Probiotics
1 tablet twice daily

Locations

Country	Name	City	State
Israel	Ziv Medical Center	Safed

Sponsors (1)

Lead Sponsor	Collaborator
Ziv Hospital

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes