Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
110 participants
INTERVENTIONAL
2025-11-03
2027-06-01
Brief Summary
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The main question it aims to answer is:
• Is the multistrain probiotic OMNi-BiOTiC® Hetox effective in in improving patient-reported disability after neurosurgery?
Researchers will compare the probiotic group and the placebo group to determine if the healing is significantly different between the groups.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Probiotic
Lacticaseibacillus casei W56 Lactobacillus acidophilus W37 Levilactobacillus brevis W63 Lactococcus lactis W58 Lactococcus lactis W19 Bifidobacterium lactis W52 Ligiactobacillus salivarius W24 Bifidobacterium lactis W51 Bifidobacterium bifidum W23 corn starch, maltodextrin, plant protein, potassium chloride, magnesium sulphate, amylase manganese sulphate
OMNi-BiOTiC® Hetox multistrain probiotic
OMNi-BiOTiC® Hetox multistrain probiotic
Placebo
corn starch, maltodextrin, plant protein, potassium chloride, magnesium sulphate, amylase manganese sulphate
Placebo
Placebo
Interventions
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OMNi-BiOTiC® Hetox multistrain probiotic
OMNi-BiOTiC® Hetox multistrain probiotic
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* Able to provide written informed consent
* Willing to comply with study procedures and follow-up assessments
* No contraindications to probiotic administration
Exclusion Criteria
* chronic diseases,
* use of probiotics one month before inclusion.
18 Years
ALL
Yes
Sponsors
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University Medical Centre Maribor
OTHER
University Maribor
OTHER
Responsible Party
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Sabina Fijan
Full prof. dr.
Principal Investigators
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TOMAŽ ŠMIGOC, dr. med.
Role: STUDY_DIRECTOR
University Medical Centre Maribor
Sabina Fijan, Ph.D.
Role: STUDY_DIRECTOR
University of Maribor
Locations
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University Medical Centre Maribor
Maribor, , Slovenia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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UKC-MB-KME-38/24
Identifier Type: -
Identifier Source: org_study_id
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