Probiotics to aid recovery after neurosurgery
The Multistrain Probiotic OMNi-BiOTiC® Hetox for Treatment After Neurosurgery (ProSURG)
This test will see if taking the multistrain probiotic OMNi‑BiOTiC Hetox after neurosurgery helps adults recover better, have less pain, and fewer post-surgical complications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Maribor Academic / other |
| Locations | 1 site (Maribor) |
| Trial ID | NCT07200518 on ClinicalTrials.gov |
What this trial studies
This randomized, placebo-controlled trial compares a multistrain probiotic (OMNi‑BiOTiC Hetox) to a matching placebo in adults who underwent neurosurgery for MRI-confirmed lumbar or cervical disc herniation, stenosis, or instability. Participants are randomly assigned to receive either the probiotic or placebo and are followed with patient-reported disability measures, pain assessments, and monitoring for postoperative complications. The trial excludes people with acute infection, chronic diseases, or recent probiotic use to reduce confounding. All visits and treatments take place at the University Medical Centre Maribor.
Who should consider this trial
Good fit: Adults with MRI-confirmed lumbar or cervical disc herniation, stenosis, or instability who can give informed consent and have no contraindications to probiotics are ideal candidates.
Not a fit: Patients with active infections, chronic diseases, or who used probiotics within the month before enrollment are excluded and unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the probiotic could speed recovery, reduce pain, and lower the rate of post-surgical complications after spine neurosurgery.
How similar studies have performed: Probiotics have shown benefits for recovery and infection reduction in some other surgical settings, but their use specifically after neurosurgery or spinal surgery is relatively novel and not well established.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Maribor
- University Medical Centre Maribor — Maribor, Slovenia (Recruiting)
Study contacts
- Study coordinator: SABINA FIJAN, Ph.D.
- Email: sabina.fijan@um.si
- Phone: +38623004755
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.