MedTrace Logo

Efficacy of Vivomixx on Behaviour and Gut Function in Autism Spectrum Disorder

NCT03369431 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2022-03-08

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Vivomixx

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.

DIETARY_SUPPLEMENT

Placebo

4.4 grams of maltose and silicon dioxide per sachet

Sponsors & Collaborators

  • University College, London

    lead OTHER

Principal Investigators

  • Anton V Emmanuel, MBBS, FRCP · University College, London

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
3 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-01
Primary Completion
2020-10-02
Completion
2021-01-29

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03369431 on ClinicalTrials.gov