CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 69 enrolled
Drug / intervention
Vivomixx +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.

Search/NCT03369431
NCT03369431N/ACompleted

The Efficacy of the Multistrain Probiotic, Vivomixx, on Behaviour and Gastrointestinal Symptoms in Children With Autism Spectrum Disorder (ASD)

University College, London·interventional·Posted Dec 12, 2017·Updated Mar 8, 2022

In Brief

A clinical study evaluating Vivomixx and Placebo for Autism Spectrum Disorder. Completed, enrolled 69 participants across 1 site.

Detailed Summary

The purpose of this study is to assess the effects of 3 months supplementation with the multi strain probiotic Vivomixx on the overall function, aberrant behaviours and frequency of gastrointestinal symptoms in children with Autism Spectrum Disorders and co-morbid gastrointestinal symptoms. The investigators will also assess the effect of the intervention on parenting stress. A further issue will be to identify any predictors of response to the probiotic. Finally, the investigators will assess whether there is an association between altered behaviour and altered gut function in users of Vivomixx.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedDec 12, 2017
Enrollment StartFeb 1, 2018
Primary CompletionOct 2, 2020
Study CompletionJan 29, 2021
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 8.6 years ago

Interventions

Vivomixxdietary

Multi-strain probiotic containing 450 billion lyophilized bacterial cells per sachet belonging to 8 probiotic strains. The probiotic strains contained in the intervention are Streptococcus thermophilus, Bifidobacterium breve, Bifidobacterium longum, Bifidobacterium infantis, Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus paracasei, Lactobacillus delbrueckii subsp. bulgaricus.

Placebodietary

4.4 grams of maltose and silicon dioxide per sachet