Effect of Probiotics After Neurosurgery

ConditionHealing

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity Maribor

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

chronic diseases,

use of probiotics one month before inclusion.

Trial design

Design model

Parallel

Treatments tested in this trial

OMNi-BiOTiC® Hetox multistrain probiotic
Dietary supplement
OMNi-BiOTiC® Hetox multistrain probiotic
Placebo
Dietary supplement
Placebo

Treatment groups

110 Participants

are divided into 2 treatment groups

Group A: ProbioticExperimental treatment 1 intervention

Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Maribor

Lead sponsor

University Medical Centre Maribor

Collaborator

Source ClinicalTrials.gov

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