ClinicalTrials.gg
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

From the registry’s dates

  • Started Nov 2025; still recruiting 1 year later.
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

In context

Lead sponsor

University Maribor is the lead sponsor of 11 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • adults with MRI-confirmed disc herniation, stenosis, or instability of the lumbar or cervical spine.
  • Able to provide written
  • Willing to comply with study procedures and follow-up assessments
  • No 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

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

06

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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 ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion