Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2025-12-29 @ 6:36 AM
Study NCT ID:
NCT06906068
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-02
First Post:
2025-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessing the Impact of Probiotic Supplementation in Children Diagnosed With Autism Spectrum Disorder: the PROBI-O-TISM Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}], 'ancestors': [{'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 108}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2028-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-25', 'studyFirstSubmitDate': '2025-03-19', 'studyFirstSubmitQcDate': '2025-03-25', 'lastUpdatePostDateStruct': {'date': '2025-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean change in ATEC (Autism Treatment Evaluation Checklist) total score between baseline and week 14', 'timeFrame': '14 weeks', 'description': 'Mean change in ATEC total score between baseline and week 14 will be compared to verify the supplementation effects. ATEC scale consists of 77 items grouped into four subscales: (1) language, (2) perception, (3) sociability and (4) behavior. The total score is 0-179; the higher the score, the more severe ASD-related behaviors'}], 'secondaryOutcomes': [{'measure': 'Mean change in ATEC (Autism Treatment Evaluation Checklist) total score between week 14 and week 18', 'timeFrame': '4 weeks', 'description': 'Mean change in ATEC total score between week 14 and week 18 will be compared to verify persistence of treatment effects after wash-out (product cessation). The total score is 0-179; the higher the score, the more severe ASD-related behaviors.'}, {'measure': 'Mean change in each ATEC (Autism Treatment Evaluation Checklist) sub-scores (language, perception, sociability, and behavior) between baseline , week 14 and week 18 .', 'timeFrame': 'Baseline, 14 weeks and 18 weeks', 'description': 'Mean change in each ATEC sub-scores (language, perception, sociability, and behavior) will be compared between baseline, week 14 to verify supplementation effect and week 18 to evaluate persistence of treatment effects after wash-out (product cessation). The total score is 0-179; the higher the score, the more severe ASD-related behaviors.'}, {'measure': 'Mean change in ATEC (Autism Treatment Evaluation Checklist) total score at week 4 and week 8 from baseline.', 'timeFrame': '4 weeks and 8 weeks', 'description': 'Mean change in ATEC total score at week 4 and from baseline will be collected to document effect over time. The total score is 0-179; the higher the score, the more severe ASD-related behaviors'}, {'measure': 'Mean change in VABS-III (adaptive behavior skills) total and sub-scores between baseline, week 14 and week 18.', 'timeFrame': 'Baseline, 14 weeks and 18 weeks', 'description': 'Mean change in VABS-III total and sub-scores will be compared between baseline, week 14 to determine supplementation effect and week 18 to verify persistence of treatment effects after wash-out (product cessation). It consists of four subscales: communication, daily living skills, socialization and motor skills. The total score (range 0-72) and the four sub-scores total will be calculated. The higher scores indicate higher levels of functioning.'}, {'measure': 'Mean change in 6-GSI (6-Gastrointestinal Severity Index) score between baseline, week 4, week 8, week 14 and week 18.', 'timeFrame': 'From baseline up to 18 weeks.', 'description': 'Mean change in 6-GSI score will be compared between baseline, week 4, week 8, week 14 to evaluate supplémentation effect and week 18 to verify to persistence of treatment effects after wash-out (product cessation).The total score is 0-12, with higher values indicating greater severity.'}, {'measure': "Mean change in CSHQ (Child's Sleep Habits Questionnaire) total and sub-scores between baseline, week 4, week 8, week 14 and week 18.", 'timeFrame': 'From baseline up to 18 weeks', 'description': 'Mean change in CSHQ total and sub-scores will be compared between baseline, week 4, week 8, week 14 to evaluate suplementation effects and week 18 to verify persistence of treatment effects after wash-out (product cessation). Total score is 33-99 divided in eight subscales: (1) bedtime resistance, (2) sleep-onset delay, (3) sleep duration, (4) sleep anxiety, (5) nocturnal awakenings, (6) parasomnias, (7) sleep disordered breathing and (8) morning waking/daytime sleepiness. The higher the CSHQ score the greater the complaints.'}, {'measure': 'Mean change in Pediatric Quality of Life Inventory (PedsQL) score between baseline, week 14 and week 18.', 'timeFrame': 'Baseline, 14 weeks and 18 weeks', 'description': 'Mean change in PedsQL score will be compared between baseline, week 14 to evaluate supplementation effects and week 18 to verify persistence of treatment effects after wash-out (product cessation). PedsQ consists in 23 items and four subscales: physical functioning, emotional functioning, social functioning and school functioning. A higher score represents better health related QoL.'}, {'measure': 'Mean change in Parenting Stress Index-Short Form (PSI-SF) score between baseline, week 14 and week 18.', 'timeFrame': 'Baseline, 14 weeks and 18 weeks', 'description': 'Mean change in PSI-SF score will be compared between baseline, week 14 to determine supplementation effects and week 18 to verify persistence of treatment effects after wash-out (product cessation). It is divided into three domains: parental distress, dysfunctional parent-child interaction and difficult child, with a total score ranging from 36 to 180. A higher score indicates a higher clinical level of distress.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gastrointestinal symptoms', 'Sleep disorder', 'Probiotics', 'Microbiota', 'Autism Spectrum Disorder'], 'conditions': ['Autism Spectrum Disorder']}, 'descriptionModule': {'briefSummary': "Children with autism spectrum disorder (ASD) present with stereotyped behaviors and often with comorbidities including gastrointestinal symptoms and sleep disturbances. These affect the quality of life of both children and parents. As of now, interventions available to manage ASD-related behaviors rely heavily on the services of professionals who are often difficult to access. What is even more striking is that there are currently no approved medications to treat the core symptoms of ASD. There is an important need for additional strategies to manage severity of ASD and to develop new treatments.\n\nTargeting the bacteria living in the intestine, named 'gut microbiota', by using probiotics is an avenue that has been proposed by other groups to improve behaviors associated with ASD and gastrointestinal symptoms. However, these studies have important limitations, pressing the need for robustly designed interventions.\n\nPreviously, the PROBI-O-TISM pilot study was conducted at CHU Sainte-Justine. The investigators confirmed that the Bio-K+ probiotic beverage is acceptable and safe for autistic children and that the proposed study protocol is feasible. The study also led to promising preliminary results suggesting a beneficial effect of the probiotics on behaviors, gastrointestinal symptoms and sleep.\n\nThe proposed study will answer the question: ''Does supplementing with Bio-K+ probiotics reduce the severity of autistic behaviors and comorbidities in children with a diagnosis of ASD? '' The investigators will use a solid study design, a double-blinded randomized controlled-trial with placebo, to test the efficacy of a 14-week treatment with daily Bio-K+ probiotic supplement in children aged 4 to 11 years old. The investigators will also study the impact of the supplementation on other parameters such as quality of life, gut microbiota and brain signaling.\n\nThis is a unique opportunity to test a simple approach to improve behaviors and comorbidities in autistic children."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Being an autistic child with normal intelligence as documented by a neuropsychology assessment at the time of ASD diagnosis based on the ADOS score and the clinical impression of a multidisciplinary team of experts in autism diagnosis in the Department of Psychiatry;\n* Being between the ages of 4 and 11 years;\n* Acceptance and ability of the child to consume the probiotics product.\n\nExclusion Criteria:\n\n* Epilepsy;\n* Autism in the context of a genetic syndrome such as Fragile X or Bourneville sclerosis;\n* Known presence of cancer, diabetes, celiac disease or inflammatory bowel disease (Crohn's disease or ulcerative colitis);\n* Genetic disorder such as trisomy 21 or 14;\n* Immune system disorder;\n* Intolerance or allergy to Bio-K+ pea-based probiotics;\n* Having taken antibiotics or probiotics in the previous 3 months"}, 'identificationModule': {'nctId': 'NCT06906068', 'acronym': '(PROBI-O-TISM)', 'briefTitle': 'Assessing the Impact of Probiotic Supplementation in Children Diagnosed With Autism Spectrum Disorder: the PROBI-O-TISM Study', 'organization': {'class': 'OTHER', 'fullName': "St. Justine's Hospital"}, 'officialTitle': 'Assessing the Impact of Probiotic Supplementation in Children Diagnosed With Autism Spectrum Disorder: the PROBI-O-TISM Study', 'orgStudyIdInfo': {'id': '2025-8319'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Probiotic', 'description': 'A fermented probiotic beverage containing 3 lactobacilli', 'interventionNames': ['Dietary Supplement: Three strains of Lactobacillus: L. acidophilus CL1285®, L. casei LBC80R® and L. rhamnosus CLR2®']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'A beverage without bacteria (identical taste and nutritional content to the probiotic beverage)', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Three strains of Lactobacillus: L. acidophilus CL1285®, L. casei LBC80R® and L. rhamnosus CLR2®', 'type': 'DIETARY_SUPPLEMENT', 'description': 'A probiotic beverage (98 g) at dose of 50.10\\^9 CFU, taken once daily for 14 weeks.', 'armGroupLabels': ['Probiotic']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Non fermented beverage (98 g) with no probiotic strains, taken once daily for 14 weeks.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H3T 1C5', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'contacts': [{'name': 'Valérie Marcil, Professor', 'role': 'CONTACT', 'email': 'valerie.marcil@umontreal.ca', 'phone': '514-345-4931', 'phoneExt': '3272'}, {'name': 'Ghizlane Gaougaou, Research Associate', 'role': 'CONTACT', 'email': 'ghizlane.gaougaou@umontreal.ca', 'phone': '514-345-4931', 'phoneExt': '5745'}, {'name': 'Valérie Marcil, Professor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Sainte-Justine', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'centralContacts': [{'name': 'Valérie Marcil, Professor', 'role': 'CONTACT', 'email': 'valerie.marcil@umontreal.ca', 'phone': '514 345-4931', 'phoneExt': '3272'}, {'name': 'Ghizlane Gaougaou, Research associate', 'role': 'CONTACT', 'email': 'ghizlane.gaougaou@umontreal.ca', 'phone': '514 345-4931', 'phoneExt': '5745'}], 'overallOfficials': [{'name': 'Valérie Marcil, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St. Justine's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'IPD might be shared to other research upon resonable request to the Principal Investigator/Sponsor.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Valérie Marcil', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hôpital du Sacré-Coeur de Montréal (CIUSSS - NIM)', 'class': 'UNKNOWN'}, {'name': 'University of Ottawa', 'class': 'OTHER'}, {'name': 'Institut universitaire de cardiologie et de pneumologie de Québec, University Laval', 'class': 'OTHER'}, {'name': 'Institut National de la Recherche Scientifique - Centre Armand Frappier Santé Biotechnologie', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Valérie Marcil', 'investigatorAffiliation': "St. Justine's Hospital"}}}}