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| Name | Class |
|---|---|
| University Medical Centre Maribor | OTHER |
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The goal of this randomised controlled trial is to determine the effect of consuming a multistrain probiotic OMNi-BiOTiC® Hetox on improving the healing, pain management, and postsurgical complications after neurosurgery.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic | Experimental | 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 |
|
| Placebo | Placebo Comparator | corn starch, maltodextrin, plant protein, potassium chloride, magnesium sulphate, amylase manganese sulphate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OMNi-BiOTiC® Hetox multistrain probiotic | Dietary Supplement | OMNi-BiOTiC® Hetox multistrain probiotic |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Oswestry Disability Index (ODI) at 3 months | Functional disability will be assessed using the Oswestry Disability Index (ODI, version 2.1a; range 0-100, higher = greater disability). The primary outcome is the mean change in ODI from baseline to 3 months post-neurosurgery. | 4 weeks supplementation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| SABINA FIJAN, Ph.D. | Contact | +38623004755 | sabina.fijan@um.si |
| Name | Affiliation | Role |
|---|---|---|
| TOMAŽ ŠMIGOC, dr. med. | University Medical Centre Maribor | Study Director |
| Sabina Fijan, Ph.D. | University of Maribor | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Centre Maribor | Recruiting | Maribor | Slovenia |
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| Placebo | Dietary Supplement | Placebo |
|