At a glance
ClinicalIndex Comparison RecordN/ACompleted· 43 enrolled
Drug / intervention
L.Reuteri +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Efficacy of Lactobacillus Reuteri in Managing Social Deficits in Children With Autistic Spectrum Disorder: a Randomized Clinical Trial With Evaluation of Gut Microbiota and Metabolomics Profiles
In Brief
A clinical study evaluating L.Reuteri and Placebo for Autism Spectrum Disorder. Completed, enrolled 43 participants across 2 sites.
Detailed Summary
The aim of this study is to assess the effects of a 6-months probiotic supplementation on behavioral profiles, microbiota and metabolic profiles, inflammatory biomarkers, gastrointestinal disturbances, in children with Autism Spectrum Disorders (ASD) with or without GI symptoms.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAutism Spectrum Disorder
CountriesItaly
CollaboratorsUniversity of Bari
Timeline
N/ACompletedFinished
2020202120222023202420252026
First PostedMar 2020
Enrollment StartApr 2020
Primary CompletionOct 2020
Study CompletionAug 2021
TodayJul 2026
First PostedMar 3, 2020
Enrollment StartApr 1, 2020
Primary CompletionOct 30, 2020
Study CompletionAug 30, 2021
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 6.3 years ago
Interventions
L.Reuteridietary
daily supplementation with two tablet for six months
Placebodietary
daily supplementation with two tablet for six months