NCT07200518

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
13mo left

Started Nov 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress32%
Nov 2025Jun 2027

First Submitted

Initial submission to the registry

September 18, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 1, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

November 3, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

November 28, 2025

Status Verified

November 1, 2025

Enrollment Period

1.2 years

First QC Date

September 18, 2025

Last Update Submit

November 21, 2025

Conditions

Healing

Keywords

neurosurgeryprobioticsOmni-Biotic Hetox

Outcome Measures

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.

    4 weeks supplementation

Study Arms (2)

Probiotic

EXPERIMENTAL

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

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

OMNi-BiOTiC® Hetox multistrain probioticDIETARY_SUPPLEMENT

OMNi-BiOTiC® Hetox multistrain probiotic

Probiotic
PlaceboDIETARY_SUPPLEMENT

Placebo

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • symptoms of acute infection (vomiting, fever above 38°C, diarrhea, respiratory symptoms),
  • chronic diseases,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Centre Maribor

Maribor, Slovenia

RECRUITING

Study Officials

  • TOMAŽ ŠMIGOC, dr. med.

    University Medical Centre Maribor

    STUDY DIRECTOR

  • Sabina Fijan, Ph.D.

    University of Maribor

    STUDY DIRECTOR

Central Study Contacts

SABINA FIJAN, Ph.D.

CONTACT

+38623004755sabina.fijan@um.si

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full prof. dr.

Study Record Dates

First Submitted

September 18, 2025

First Posted

October 1, 2025

Study Start

November 3, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

June 1, 2027

Last Updated

November 28, 2025

Record last verified: 2025-11

Locations

SL(1)