NCT01679366

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2012

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2012

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 6, 2012

Completed
25 days until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

October 22, 2014

Status Verified

November 1, 2011

Enrollment Period

11 months

First QC Date

August 16, 2012

Last Update Submit

October 21, 2014

Conditions

Throat Pain

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • analysis

    10 days

Study Arms (3)

Penicillin G

NO INTERVENTION

hospitalization of 30 patients given penicilline intraveniously for 72 hours

Placebo

PLACEBO COMPARATOR

30 hospitalized patients will be given placebo with a regular penicillin treatment

Drug: Placebo

Probiotic

EXPERIMENTAL

Probiotics will be given to 30 hospitalized patients with regular penicillin treatment

Drug: Probiotics

Interventions

PlaceboDRUG

1 tablet 2 times daily

Also known as: Sugar pill for mimic probiotics
Placebo
ProbioticsDRUG

1 tablet twice daily

Also known as: BLIS
Probiotic

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age over 18 years
  • Acute pharyngotonsillitis for which hospitalization for intravenous antibiotic treatment and/or fluids is needed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ziv Medical Center

Safed, Israel

Location

MeSH Terms

Conditions

Pharyngitis

Interventions

SugarsProbiotics

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsPharyngeal DiseasesStomatognathic DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

CarbohydratesDietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Leonid Livshits, MD

    Ziv Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2012

First Posted

September 6, 2012

Study Start

October 1, 2012

Primary Completion

September 1, 2013

Study Completion

October 1, 2013

Last Updated

October 22, 2014

Record last verified: 2011-11

Locations

IL(1)