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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Ziv Hospital

ClinicalTrials.gov Identifier:

NCT01679366

First received: August 16, 2012

Last updated: October 21, 2014

Last verified: November 2011

History of Changes

Purpose

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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
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.

Eligibility


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

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

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 ClinicalTrials.gov identifier: NCT01679366

Locations


Israel
Ziv Medical Center
Safed, Israel

Sponsors and Collaborators

Ziv Hospital

Investigators


Principal Investigator:	Leonid Livshits, MD	Ziv Medical Center

More Information


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

Additional relevant MeSH terms:


Penicillins Anti-Bacterial Agents Anti-Infective Agents

ClinicalTrials.gov processed this record on September 23, 2016

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