Healing
Conditions
Keywords
neurosurgery, probiotics, Omni-Biotic Hetox
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTOMNi-BiOTiC® Hetox multistrain probiotic
OMNi-BiOTiC® Hetox multistrain probiotic
DIETARY_SUPPLEMENTPlacebo
Placebo
Sponsors
University Medical Centre Maribor
University Maribor
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* adults with MRI-confirmed disc herniation, stenosis, or instability of the lumbar or cervical spine. * Able to provide written informed consent * Willing to comply with study procedures and follow-up assessments * No contraindications to probiotic administration
Exclusion criteria
* symptoms of acute infection (vomiting, fever above 38°C, diarrhea, respiratory symptoms), * chronic diseases, * use of probiotics one month before inclusion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Oswestry Disability Index (ODI) at 3 months | 4 weeks supplementation | 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. |
Countries
Slovenia
Contacts
Primary ContactSABINA FIJAN, Ph.D.
Outcome results
None listed