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

NCT05261152 | Completed Phase 4

• 1 other identifier: 264/21
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Saccharomyces boulardii, antibiotic-associated diarrhea

Outcome Measures

Primary Outcomes (2)

• gastrointestinal symptoms and signs

  stool frequency and consistency, nausea, gas production (meteorism), bloating, abdominal pain

  21 days

• fever

  symptom / measured body temperature

  21 days

Study Arms (2)

Probiotic group

EXPERIMENTAL

Capsules are containing S. boulardii and were administered twice daily (250 mg). The administration of investigated product started within 30 min before the first dose of the antibiotic and continued for 21 days.

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

Placebo group

PLACEBO COMPARATOR

Capsules are containing placebo and were administered twice daily. The administration of investigated product started within 30 min before the first dose of the antibiotic and continued for 21 days.

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

Interventions

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

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

Also known as: Sacharomyces boulardi,

Placebo group; Probiotic group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects age ≥65 years.
• Informed consent (IC) obtained and signed prior to study participation
• For female subjects: proof of being at least 1 year post-menopausal
• Expected minimum hospital stay of 5 days
• Requiring ≥5 day course of intravenous (IV) antibiotic
• Diagnosis of lower respiratory tract infection (LRTI)
• The subject is willing and able to comply with all testing and study requirements as defined in the protocol.

You may not qualify if:

• Active diarrhea (where diarrhea is defined as 3 or more unformed/liquid stools on day prior to randomization)
• Subjects with diarrhea in past 2 weeks
• Current treatment for CDAD or ongoing active CDAD infection, as evidenced by clinical signs of diarrhea along with the presence of toxin A and/or B (or their respective genes) of C. difficile in the stool
• Number of previous CDAD episodes \>1
• Any previously documented CDI within 8 weeks prior to randomization
• Use of broad spectrum antibiotics within 2 months of start of study drug. Antibiotics including those not specified in this protocol for the treatment of the current CAP episode are allowed within 24 h of start of study drug and the protocol-defined treatment for CAP.
• Current treatment with non-beta lactam antibiotics other than macrolides
• Risk of death within 90 days of study entry according to the clinical judgment of the investigator
• Known intolerance of study drug/ingredients
• History of or active, non-controlled inflammatory bowel disease such as Crohn's Disease or ulcerative colitis; evidence of other GI infections ie parasitic infection, Salmonella, Shigella, history of colon carcinoma, irritable bowel syndrome (IBS)
• Subjects with aspiration pneumonia
• Subjects with chronic alcoholism
• Subjects with confirmed influenza
• Neutrophil count \<500 cells/mm3
• Patients with subclavian central line

Sponsors & Collaborators

• Clinical Centre of Serbia: lead
• Institute for Pulmonary Diseases of Vojvodina: collaborator

Study Sites (2)

Clinical Center of Serbia

Belgrade, Serbia

Location

Institute for Pulmonary Diseases of Vojvodina

Novi Sad, Serbia

Location

MeSH Terms

Interventions

Dosage Forms

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Study Officials

• Branislava Milenkovic, Prof, MD

  Clinic for Pulmonary Diseases, Clinical Center of Serbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. MD, PhD

Study Record Dates

• First Submitted: February 19, 2022
• First Posted: March 2, 2022
• Study Start: November 1, 2017
• Primary Completion: December 1, 2018
• Study Completion: December 31, 2018
• Last Updated: March 2, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)