Efficacy of BLIS K12 as Preventive Measure for Rheumatic Children

April 2, 2015 updated by: Dr Yael Garty MD, Kaplan Medical Center

Efficacy of Streptococcus Salivarius BLIS (Bacteriocin-like Inhibitory Substance) K12 as Preventive Measure for Rheumatic Children.

The purpose of this study is to determine whether daily treatment with Streptococcus Salivarius BLIS K-12 prevents streptococcal throat infection in children that have had an episode of rheumatic fever.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Children diagnosed with Rheumatic fever are currently given preventive streptococcal treatment with either monthly IM (intramuscular injection) Penicillin or daily oral Penicillin.

This preventive treatment is recommended for years until the child is 20 y old or even later. The compliance rate for this treatment declines significantly with time (the injections are painful) and even with good adherence the prevention is not complete.

In the last few years a new product licensed as "BLIS K-12" has been developed and approved by FDA as GRAS (generally recognized as safe) status from 2011.

This probiotic treatment prevents the pathogenic Strep A from adhering to the throat of the child thus preventing the infection. This kind of prevention is better for the long run for the patient and for the surrounding, It is better tolerated, is effective even if a dose is skipped or missed is not painful and is tasty to the children.

So the investigators assumption is that giving this product to children instead of Penicillin either orally or intramuscularlly will be better tolerated thus give a better protection profile with much less side effects.

The investigators will be giving BLIS K-12 to those children on the trial on a daily basis for 6 autumn-winter months instead of Penicillin and will monitor the children by monthly throat swabs. The investigators will also obtain Anti Streptolysin blood test at the end of the period from all participants to evaluate possible Strep encounters.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Rheumatic heart disease with recommended strep prophylaxis

Exclusion Criteria:

  • less than one year from first diagnosis
  • refusal to take the tablets

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BLIS K12 treatment
Once daily tablet of Streptococcus Salivarius BLIS K 12 to be slowly dissolved orally every evening for six month
Dietary supplement: Streptococcus Salivarius BLIS K12
Once daily tablet of BLIS K 12 to be slowly dissolved orally every evening.
Other Names:
  • Bio-BLIS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
number of Strep throat infections while in study
Time Frame: six month
six month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaplan Medical Center

Investigators

  • Principal Investigator: Yael Garty, MD, Attending Physician

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Anticipated)

March 1, 2016

Study Registration Dates

First Submitted

March 30, 2015

First Submitted That Met QC Criteria

March 30, 2015

First Posted (Estimate)

April 2, 2015

Study Record Updates

Last Update Posted (Estimate)

April 3, 2015

Last Update Submitted That Met QC Criteria

April 2, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 027-15-KMC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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