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S. Boulardii in Prevention of Antibiotic-associated Diarrhea in Hospitalized Adults With Respiratory Tract Infections

NCT05261152 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2022-03-02

No results posted yet for this study

Summary

Antibiotic-associated diarrhea (AAD) is the most common gastrointestinal complication of antibiotic use, with potentially serious clinical impact. The aim of this study is to assess the efficacy and safety of Saccharomyces boulardii in the prevention of AAD in adult patients with lower respiratory tract infection (LRTI) treated in a hospital.

A multicenter, randomized, parallel-group, double-blind, placebo-controlled study is conducted whereby adults who are hospitalized due to LRTI and treated with intravenous antibiotics and randomized to capsules containing S. boulardii or indistinguishable placebo. The outcome measures were: relevant clinical features, gastrointestinal symptoms, and adverse events.

Conditions

  • Prevention & Control
  • Diarrhea Caused by Drug
  • Respiratory Infection Bacterial
  • Anti-Bacterial Agents

Interventions

DRUG

drug product: capsules are containing S. boulardii, administered twice daily (250 mg)

Randomisation: 1:1 Capsules containing S. boulardii twice daily (250 mg) or indistinguishable capsules containing placebo twice daily.

Sponsors & Collaborators

  • Institute for Pulmonary Diseases of Vojvodina

    collaborator UNKNOWN

  • Clinical Centre of Serbia

    lead OTHER

Principal Investigators

  • Branislava Milenkovic, Prof, MD · Clinic for Pulmonary Diseases, Clinical Center of Serbia

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-01
Primary Completion
2018-12-01
Completion
2018-12-31

Countries

  • Serbia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05261152 on ClinicalTrials.gov