Effect of Probiotics After Neurosurgery (ProSURG)

University Maribor

Status: Enrolling

Conditions: Healing

Treatments: Dietary Supplement: OMNi-BiOTiC® Hetox multistrain probiotic; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07200518

UKC-MB-KME-38/24

Details and patient eligibility

About

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.

Enrollment: 110 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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110 participants in 2 patient groups, including a placebo group

Probiotic

Experimental group

Description:

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

Treatment:

Dietary Supplement: OMNi-BiOTiC® Hetox multistrain probiotic

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo