Effect of Probiotics After Neurosurgery

NCT ID: NCT07200518

Last Updated: 2025-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-03

Study Completion Date

2027-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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Healing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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

Group Type EXPERIMENTAL

OMNi-BiOTiC® Hetox multistrain probiotic

Intervention Type DIETARY_SUPPLEMENT

OMNi-BiOTiC® Hetox multistrain probiotic

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo

Interventions

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OMNi-BiOTiC® Hetox multistrain probiotic

OMNi-BiOTiC® Hetox multistrain probiotic

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Medical Centre Maribor

OTHER

Sponsor Role collaborator

University Maribor

OTHER

Sponsor Role lead

Responsible Party

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Sabina Fijan

Full prof. dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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TOMAŽ ŠMIGOC, dr. med.

Role: STUDY_DIRECTOR

University Medical Centre Maribor

Sabina Fijan, Ph.D.

Role: STUDY_DIRECTOR

University of Maribor

Locations

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University Medical Centre Maribor

Maribor, , Slovenia

Site Status RECRUITING

Countries

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Slovenia

Central Contacts

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SABINA FIJAN, Ph.D.

Role: CONTACT

+38623004755

Facility Contacts

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Tomaž Šmigoc, dr.med.

Role: primary

+3862 321 1000

Other Identifiers

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UKC-MB-KME-38/24

Identifier Type: -

Identifier Source: org_study_id

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