Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01679366
Recruitment Status : Completed
First Posted : September 6, 2012
Last Update Posted : October 22, 2014
Sponsor:
Information provided by (Responsible Party):
Ziv Hospital

Tracking Information
First Submitted Date  ICMJE August 16, 2012
First Posted Date  ICMJE September 6, 2012
Last Update Posted Date October 22, 2014
Study Start Date  ICMJE October 2012
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 2, 2012)
period of disease [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 2, 2012)
analysis [ Time Frame: 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effectiveness of Probiotics for the Therapy of Acute Pharyngotonsillitis in Adult Patients
Official Title  ICMJE The Effectiveness of Probiotics for the Therapy of Acute Pharyngotonsillitis in Adult Patients
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Throat Pain
Intervention  ICMJE
  • Drug: Placebo
    1 tablet 2 times daily
    Other Name: Sugar pill for mimic probiotics
  • Drug: Probiotics
    1 tablet twice daily
    Other Name: BLIS
Study Arms  ICMJE
  • 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
    Intervention: Drug: Placebo
  • Experimental: Probiotic
    Probiotics will be given to 30 hospitalized patients with regular penicillin treatment
    Intervention: Drug: Probiotics
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 21, 2014)
57
Original Estimated Enrollment  ICMJE
 (submitted: September 2, 2012)
90
Actual Study Completion Date  ICMJE October 2013
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01679366
Other Study ID Numbers  ICMJE 0054-11-ZIV
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ziv Hospital
Study Sponsor  ICMJE Ziv Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Leonid Livshits, MD Ziv Medical Center
PRS Account Ziv Hospital
Verification Date November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP