Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:05 AM
Study NCT ID:
NCT07200518
Status:
RECRUITING
Last Update Posted:
2025-11-28
First Post:
2025-09-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Probiotics After Neurosurgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-21', 'studyFirstSubmitDate': '2025-09-18', 'studyFirstSubmitQcDate': '2025-09-26', 'lastUpdatePostDateStruct': {'date': '2025-11-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in Oswestry Disability Index (ODI) at 3 months', 'timeFrame': '4 weeks supplementation', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['neurosurgery', 'probiotics', 'Omni-Biotic Hetox'], 'conditions': ['Healing']}, 'descriptionModule': {'briefSummary': '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.\n\nThe main question it aims to answer is:\n\n• Is the multistrain probiotic OMNi-BiOTiC® Hetox effective in in improving patient-reported disability after neurosurgery?\n\nResearchers will compare the probiotic group and the placebo group to determine if the healing is significantly different between the groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adults with MRI-confirmed disc herniation, stenosis, or instability of the lumbar or cervical spine.\n* Able to provide written informed consent\n* Willing to comply with study procedures and follow-up assessments\n* No contraindications to probiotic administration\n\nExclusion Criteria:\n\n* symptoms of acute infection (vomiting, fever above 38°C, diarrhea, respiratory symptoms),\n* chronic diseases,\n* use of probiotics one month before inclusion.'}, 'identificationModule': {'nctId': 'NCT07200518', 'acronym': 'ProSURG', 'briefTitle': 'Effect of Probiotics After Neurosurgery', 'organization': {'class': 'OTHER', 'fullName': 'University Maribor'}, 'officialTitle': 'The Multistrain Probiotic OMNi-BiOTiC® Hetox for Treatment After Neurosurgery (ProSURG)', 'orgStudyIdInfo': {'id': 'UKC-MB-KME-38/24'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Probiotic', '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', 'interventionNames': ['Dietary Supplement: OMNi-BiOTiC® Hetox multistrain probiotic']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'corn starch, maltodextrin, plant protein, potassium chloride, magnesium sulphate, amylase manganese sulphate', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'OMNi-BiOTiC® Hetox multistrain probiotic', 'type': 'DIETARY_SUPPLEMENT', 'description': 'OMNi-BiOTiC® Hetox multistrain probiotic', 'armGroupLabels': ['Probiotic']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Maribor', 'status': 'RECRUITING', 'country': 'Slovenia', 'contacts': [{'name': 'Tomaž Šmigoc, dr.med.', 'role': 'CONTACT', 'email': 'tomaz.smigoc@ukc-mb.si', 'phone': '+3862 321 1000'}], 'facility': 'University Medical Centre Maribor', 'geoPoint': {'lat': 46.55583, 'lon': 15.64593}}], 'centralContacts': [{'name': 'SABINA FIJAN, Ph.D.', 'role': 'CONTACT', 'email': 'sabina.fijan@um.si', 'phone': '+38623004755'}], 'overallOfficials': [{'name': 'TOMAŽ ŠMIGOC, dr. med.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Medical Centre Maribor'}, {'name': 'Sabina Fijan, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Maribor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Maribor', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Medical Centre Maribor', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Full prof. dr.', 'investigatorFullName': 'Sabina Fijan', 'investigatorAffiliation': 'University Maribor'}}}}