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NCT Number: NCT07200518

Effect of Probiotics After Neurosurgery

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.

Recruiting

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Key information

Conditions

Healing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Centre Maribor

Maribor, Slovenia

Location status: Recruiting

Location contact

Tomaž Šmigoc, dr.med.

CONTACT

[email protected]

+3862 321 1000

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

OMNi-BiOTiC® Hetox multistrain probiotic

Dietary Supplement

OMNi-BiOTiC® Hetox multistrain probiotic

Placebo

Dietary Supplement

Placebo

Primary outcomes

  1. Change from baseline in Oswestry Disability Index (ODI) at 3 months

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

SABINA FIJAN, Ph.D.

CONTACT

[email protected]

+38623004755

Sponsors and collaborators

Lead sponsor

University Maribor

Other

Collaborators

  • University Medical Centre Maribor

Registry information

Official study title

The Multistrain Probiotic OMNi-BiOTiC® Hetox for Treatment After Neurosurgery (ProSURG)

Acronym: ProSURG

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Oct 1, 2025
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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