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

NCT ID: NCT01679366

Last Updated: 2014-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-10-31

Brief Summary

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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

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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.

Conditions

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Throat Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Penicillin G

hospitalization of 30 patients given penicilline intraveniously for 72 hours

Group Type NO_INTERVENTION

No interventions assigned to this group

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

1 tablet 2 times daily

Probiotic

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

Group Type EXPERIMENTAL

Probiotics

Intervention Type DRUG

1 tablet twice daily

Interventions

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Placebo

1 tablet 2 times daily

Intervention Type DRUG

Probiotics

1 tablet twice daily

Intervention Type DRUG

Other Intervention Names

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Sugar pill for mimic probiotics BLIS

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ziv Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Leonid Livshits, MD

Role: PRINCIPAL_INVESTIGATOR

Ziv Medical Center

Locations

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Ziv Medical Center

Safed, , Israel

Site Status

Countries

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Israel

Other Identifiers

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0054-11-ZIV

Identifier Type: -

Identifier Source: org_study_id

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