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Completed

NCT Number: NCT01679366

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

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.

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Key information

Conditions

Throat Pain Infections Otorhinolaryngologic Diseases Pharyngeal Diseases Pharyngitis Respiratory Tract Diseases Respiratory Tract Infections Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ziv Medical Center

Safed, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

1 tablet 2 times daily

Other names: Sugar pill for mimic probiotics

Probiotics

Drug

1 tablet twice daily

Other names: BLIS

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Ziv Hospital

Other Gov

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Sep 6, 2012
Registry last updated
Oct 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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