Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 10:40 PM
Study NCT ID:
NCT06448767
Status:
RECRUITING
Last Update Posted:
2024-11-12
First Post:
2024-06-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of a Multispecies Probiotics on Autism Symptoms and the Quality of Life in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}], 'ancestors': [{'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2026-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-06', 'studyFirstSubmitDate': '2024-06-03', 'studyFirstSubmitQcDate': '2024-06-03', 'lastUpdatePostDateStruct': {'date': '2024-11-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Autism Spectrum Rating Scales (ASRS)', 'timeFrame': '0-3 months', 'description': 'Assessment of the severity of ASD symptoms. Scores are reported as percentiles, with higher values indicating greater symptom severity.'}, {'measure': 'The Quality of Life in Autism Part A (QoLA-A)', 'timeFrame': '0-3 months', 'description': 'Assessment of the quality of life of parents of children with ASD. Scores range from 28 to 140 points, with higher values reflecting a better quality of life.'}], 'secondaryOutcomes': [{'measure': 'The Parenting Stress Index, 4th Edition (PSI-4) / SIPA (Stress Index for Parents of Adolescents)', 'timeFrame': '0-3 months', 'description': 'Assessment of the parenting stress intensity. The level of parental stress will be assessed using the PSI-4 questionnaire if the child is under 11 years old, or the SIPA if the child is 11 years or older. Scores range from 101 to 505 points for the PSI-4 and 90 to 450 points for the SIPA. Higher scores indicate higher level of stress.'}, {'measure': 'Children Sleep Habit Questionnaire - Abbreviated (CSHQ-A)', 'timeFrame': '0-3 months', 'description': 'Assessment of the sleep impairments. Scores range from 0 to 154 points, with higher values indicating a greater severity of sleep disturbances.'}, {'measure': 'Gastrointestinal Symptom Rating Scale (GSRS)', 'timeFrame': '0-3 months', 'description': 'Assessment of the severity of gastrointestinal symptoms. Scores range from 15 to 105 points, with higher values indicating greater severity of gastrointestinal symptoms.'}, {'measure': 'P-cresol levels in urine samples', 'timeFrame': '0-3 months', 'description': 'Assessment of the level of p-cresol in urine samples.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Autism Spectrum Disorder', 'Probiotics'], 'conditions': ['Autism Spectrum Disorder']}, 'referencesModule': {'references': [{'pmid': '41422017', 'type': 'DERIVED', 'citation': 'Kotowska-Babol M, Konowalek L, Szajewska H, Lukasik J. Effect of multispecies probiotics on autism symptoms: protocol for a randomized controlled trial (PROBAUT). Trials. 2025 Dec 20. doi: 10.1186/s13063-025-09373-w. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'In this trial, the investigators aim to evaluate the impact of a multispecies probiotic consisting of Bacillus subtilis W201, Bifidobacterium infantis W17, Bifidobacterium lactis W51, Lactobacillus acidophilus W37, Lactobacillus brevis W63, Lactobacillus rhamnosus W140, Lactococcus lactis W19, Propionibacterium freudenreichii W200, on the severity of autism symptoms and the quality of life in children with Autism Spectrum Disorder aged 7 to 15.', 'detailedDescription': 'This study is a randomized, double-blind, placebo-controlled clinical trial. One hundred and eight children aged 7 to 15 years diagnosed with Autism Spectrum Didorder will be randomly assigned in a 1:1 ratio to receive either a multispecies probiotics or a placebo for 12 weeks. The probiotic mixture contains 5 x 10\\^9 colony forming units per dose consisting of Bacillus subtilis W201, Bifidobacterium infantis W17, Bifidobacterium lactis W51, Lactobacillus acidophilus W37, Lactobacillus brevis W63, Lactobacillus rhamnosus W140, Lactococcus lactis W19, Propionibacterium freudenreichii W200.\n\nThe two co-primary outcomes will be the assessment of core autism symptoms using the Autism Symptom Rating Scales (ASRS) and quality of life measured by the Quality of Life in Autism Part A questionnaire (QoLA-A). The secondary outcomes will include evaluations of sleep impairments using Children Sleep Habit Questionnaire - Abbreviated (CSHQ-A), parental stress levels using Parenting Stress Index-III (PSI-III), gastrointestinal symptoms using Gastrointestinal Symptom Rating Scale (GSRS), and urinary p-cresol levels. These outcomes will be assessed twice: at baseline and after 12 weeks of intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosis of ASD according to the Diagnostic and Statistical Manual of Mental Disorders, the fifth edition (DSM-5) or International Classification of Diseases, Tenth Revision (ICD-10).\n2. Children either not taking any medication or receiving the same medication for the last 2 months.\n3. Patients, or their parents/caregivers, are willing to provide written informed consent, proceed with nutritional supplements throughout the 3-month trial, refrain from starting any kind of special diet for the duration of the study, and complete the questionnaires at two time points during the study.\n\nExclusion Criteria:\n\n1. Use of antibiotics in the previous 2 months before enrolling (excluding topical antibiotics).\n2. Use of probiotics or synbiotics within the previous 2 months.\n3. History of intolerance or allergy to probiotics, synbiotics or any other study product component.\n4. Surgery with bowel resection or short bowel syndrome.\n5. Children with severe immunodeficiency.'}, 'identificationModule': {'nctId': 'NCT06448767', 'acronym': 'PROBAUT', 'briefTitle': 'The Effect of a Multispecies Probiotics on Autism Symptoms and the Quality of Life in Children', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Warsaw'}, 'officialTitle': 'The Effect of a Multispecies Probiotics on Autism Symptoms and the Quality of Life in Children', 'orgStudyIdInfo': {'id': 'KB/151/2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Multispecies probiotics group', 'description': '55 participants', 'interventionNames': ['Dietary Supplement: Multispecies probiotics']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': '55 participants', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Multispecies probiotics', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Multispecies probiotics consisting of Bacillus subtilis W201, Bifidobacterium infantis W17, Bifidobacterium lactis W51, Lactobacillus acidophilus W37, Lactobacillus brevis W63, Lactobacillus rhamnosus W140, Lactococcus lactis W19, Propionibacterium freudenreichii W200 at a dose of 5x10\\^9 Colony Forming Units (CFU), once daily, orally.', 'armGroupLabels': ['Multispecies probiotics group']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo identical in taste, smell and color to the multispecies probiotics.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02-091', 'city': 'Warsaw', 'state': 'Warsaw', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Maja Kotowska, MD', 'role': 'CONTACT', 'email': 'maja.kotowska@uckwum.pl', 'phone': '+48223179536'}, {'name': 'Maja Kotowska, MD', 'role': 'CONTACT'}], 'facility': 'Department of Paediatrics, The Medical University of Warsaw', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '02-091', 'city': 'Warsaw', 'state': 'Warsaw', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Maja Kotowska', 'role': 'CONTACT', 'email': 'maja.kotowska@uckwum.pl', 'phone': '223179535'}], 'facility': 'Department of Paediatrics, The Medical University of Warsaw', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '02-091', 'city': 'Warsaw', 'state': 'Warsaw', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Maja Kotowska, MD', 'role': 'CONTACT', 'email': 'maja.kotowska@uckwum.pl', 'phone': '+223179444'}], 'facility': 'Department of Paediatrics, The Medical University of Warsaw', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'centralContacts': [{'name': 'Maja Kotowska, MD', 'role': 'CONTACT', 'email': 'kotowska.maja@gmail.com', 'phone': '+48223179536'}, {'name': 'Jan Ĺukasik, MD, PhD', 'role': 'CONTACT', 'email': 'jan.lukasik@wum.edu.pl', 'phone': '+48223179536'}], 'overallOfficials': [{'name': 'Maja Kotowska, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Paediatrics, The Medical University of Warsaw, Poland'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Warsaw', 'class': 'OTHER'}, 'collaborators': [{'name': 'Winclove Probiotics B.V.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}