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

Launched by UNIVERSITY COLLEGE, LONDON · Dec 5, 2017

Keywords

ClinConnect Summary

Potential trial participants will be recruited via one of two routes,

1. A children's charity will email parents of children with ASD on their database with a copy of our recruitment poster and asked to contact us if they wish their child to be considered for the study.
2. Information on the trial was given to attendees of a bi-annual charity conference in June 2016 run by Thinking Autism charity, which offers support to parents of children with ASD. Contact details were taken from parents who were potentially interested in their child taking part. They will be emailed a copy of the recrui...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Must have a diagnosis of ASD confirmed by a medical professional using one of the following standard assessment tools: Autism Diagnostic Interview - Revised (ADI-R), Diagnostic Interview for Social and Communication disorders (DISCO), Developmental, Dimensional and Diagnostic Interview (3di) or Autism Diagnostic Observation Schedule (ADOS).
• • Have one or more gastrointestinal symptoms (constipation, diarrhoea, abnormal stools, pain on defecation, abdominal pain, gaseousness/bloating, reflux) for the past 6 months.
• • Are either not taking any medication or have been on the same medication for the last 3 months.
• • The patient or the patient's parents/guardian are willing and able to provide a written informed consent
• • Be willing and able to continue with current medication or nutritional supplements throughout the 30-week trial.
• • The patient's primary carer must be willing and able to complete the questionnaires at three time-points in the study. These questionnaires are only available in written English.
• • Be willing to refrain from starting any kind of special diet for the duration of the study.
• • Be between 3 years and 16 years of age
• Exclusion Criteria:
• • Has a diagnosis of Retts Syndrome or Fragile X
• • Aged over 16 years or under 3 years
• • On NSAIDs
• • Taken antibiotics in the past month
• • Taken a probiotic in the past month
• • History of intolerance or allergy to probiotics
• • The patient's primary carer is not willing or are not able to complete the questionnaires at three time-points in the study. These questionnaires are only available in written English.
• • Has taken part in a clinical trial in the past 3 months