Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05261152 |
| Other study ID # |
264/21 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
November 1, 2017 |
| Est. completion date |
December 31, 2018 |
Study information
| Verified date |
February 2022 |
| Source |
Clinical Centre of Serbia |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
The participants are adult patients hospitalized due to lower respiratory tract infection
(LRTI) and treated with intravenous antibiotics. They are randomized (1:1) to capsules
containing S. boulardii twice daily (250 mg) or indistinguishable placebo twice daily. The
administration of investigated product started within 30 min before the first dose of the
antibiotic and continued for 21 days. The outcome measures (relevant clinical features,
gastrointestinal symptoms, and adverse events) were assessed in 3-time points: T1 -
screening, T2 - randomization, and T3 - hospital discharge.
The relevant gastrointestinal symptoms are: frequency and severity of nausea, bloating, gas
production, abdominal pain, fever, stool frequency between investigated groups. The median
value of stool consistency is assessed by the Bristol Stool Scale.
Visits are scheduled for V0 (screening), V1 (randomization and first use of study drug), V3
(on discharge from hospital), end of treatment (EOT) (telephone call on the 21st day after
the first dose).
Inclusion criteria are: age ≥18 years, informed consent signed before joining the survey,
diagnosis of LRTI, expected period of hospitalization: at least 5 days, necessity of
administration of ≥5 days of intravenous antibiotics, women who have not been surgically
sterilized or postmenopausal for more than a year must agree to an effective method of
contraception in order to prevent conception during the research (effective methods include
intrauterine devices, hormonal contraception and double protection).
Exclusion criteria are: active diarrhea, diarrhea in the previous two weeks, current therapy
for C. difficile-associated diarrhea (CDAD) or active C. difficile infection and CDAD, based
on the clinical picture of diarrhea with the presence of toxins A and / or B (or their genes)
C. difficile in stool, number of previous CDAD episodes> 1, previously documented infection
with C. difficile 8 weeks before randomization, use of broad-spectrum antibiotics for two
months before the start of the study drug, antibiotics, including those not defined by the
protocol for the treatment of current lower respiratory tract infection, are allowed within
the first 24 hours of starting the study drug, topical treatment with a non-beta-lactam
antibiotic other than a macrolide, risk of death within 90 days from the start of the study
according to the investigator's clinical assessment, known hypersensitivity to the study drug
or its ingredients, history of active, uncontrolled inflammatory bowel disease (Crohn's
disease, ulcerative colitis, digestive tract infections (parasitic infection, Salmonella,
Shigella, history of colorectal cancer, irritable bowel syndrome), aspiration pneumonia,
chronic alcoholism, subjects with confirmed influenza, neutrophil count <500 cells / mm3,
patients with a central vein catheter.
Aspartate Aminotransferase > 3x, Alanine Aminotransferase > 3x above the upper limit of the
reference, current chemotherapy, previous organ transplantation, participation in another
clinical study during the previous 30 days, inability or unwillingness to cooperate.
Accordingly, the researcher should evaluate any factor (eg. other regular therapy) that may
affect the validity of the treatment results.
