Effect of Probiotics After Neurosurgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: OMNi-BiOTiC® Hetox multistrain probiotic, Placebo.
- Who it may be relevant to
- Registry conditions: Healing. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Slovenia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Multistrain Probiotic OMNi-BiOTiC® Hetox for Treatment After Neurosurgery (ProSURG)
Overview
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 supplement OMNi-BiOTiC® Hetox multistrain probiotic
OMNi-BiOTiC® Hetox multistrain probiotic - Dietary supplement Placebo
Placebo
Primary outcome measures
- Change from baseline in Oswestry Disability Index (ODI) at 3 months [Time frame: 4 weeks supplementation]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Slovenia · 1 center
- University Medical Centre Maribor — Maribor
Identifiers
NCT: NCT07200518 · UKC-MB-KME-38/24