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RecruitingNCT07200518ProSURGUpdated Nov 28, 2025

Effect of Probiotics After Neurosurgery

An interventional study of OMNi-BiOTiC® Hetox multistrain probiotic and Placebo in Healing, sponsored by University Maribor. Recruiting at 1 site in Slovenia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-28.

Sponsored by University Maribor · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
110
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Healing

Keywords

  • neurosurgery
  • probiotics
  • Omni-Biotic Hetox
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  • symptoms of acute infection (vomiting, fever above 38°C, diarrhea, respiratory symptoms),
  • chronic diseases,
  • use of probiotics one month before inclusion.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
110 participants (estimated)

Study arms

  • Experimental
    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

    Dietary Supplement: OMNi-BiOTiC® Hetox multistrain probiotic

  • Placebo comparator
    Placebo

    corn starch, maltodextrin, plant protein, potassium chloride, magnesium sulphate, amylase manganese sulphate

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementOMNi-BiOTiC® Hetox multistrain probiotic

    OMNi-BiOTiC® Hetox multistrain probiotic

  • Dietary supplementPlacebo

    Placebo

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 4 weeks supplementation

06

Study locations

1 of 1 sites recruiting
  • University Medical Centre Maribor
    Maribor, Slovenia
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07200518
Lead sponsor
University Maribor
Collaborators
University Medical Centre Maribor
Responsible party
Sabina Fijan (Full prof. dr., University Maribor) — Principal investigator
First posted
Oct 1, 2025
Start date
Nov 3, 2025
Primary completion
Dec 31, 2026 (estimated)
Completion
Jun 1, 2027 (estimated)
Last update
Nov 28, 2025

Study contacts

SABINA FIJAN, Ph.D.
Contact
sabina.fijan@um.si
+38623004755
TOMAŽ ŠMIGOC, dr. med.
study director · University Medical Centre Maribor
Sabina Fijan, Ph.D.
study director · University of Maribor

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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