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

• Sponsor: Ziv Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01679366
• Collaborator: (none)
• Enrollment: 57
• Location: 1
• Arms: 3
• Duration (Months): 12
• Patients Per Site Per Month: 4.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Throat Pain	Drug: Placebo; Drug: Probiotics	Phase 3

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 Design

• Study Type: Interventional
• Actual Enrollment: 57 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: The Effectiveness of Probiotics for the Therapy of Acute Pharyngotonsillitis in Adult Patients
• Study Start Date: Oct 1, 2012
• Actual Primary Completion Date: Sep 1, 2013
• Actual Study Completion Date: Oct 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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	Drug: Placebo; 1 tablet 2 times daily; Other Names: Sugar pill for mimic probiotics
Experimental: Probiotic Probiotics will be given to 30 hospitalized patients with regular penicillin treatment	Drug: Probiotics; 1 tablet twice daily; Other Names: BLIS

Outcome Measures

Primary Outcome Measures

1. period of disease [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 Outcome Measures

1. analysis [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ziv Medical Center	Safed		Israel

Sponsors and Collaborators

• Ziv Hospital

Investigators

• Principal Investigator: Leonid Livshits, MD, Ziv Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ziv Hospital
• ClinicalTrials.gov Identifier: NCT01679366
• Other Study ID Numbers: 0054-11-ZIV
• First Posted: Sep 6, 2012
• Last Update Posted: Oct 22, 2014
• Last Verified: Nov 1, 2011

Study Results

No Results Posted as of Oct 22, 2014