Status:
COMPLETED
Efficacy of Vivomixx on Behaviour and Gut Function in Autism Spectrum Disorder
Lead Sponsor:
University College, London
Conditions:
Autism Spectrum Disorder
Eligibility:
All Genders
3-16 years
Phase:
NA
Brief 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 s...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 29 2021
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT03369431
Start Date
February 1 2018
End Date
January 29 2021
Last Update
March 8 2022
Active Locations (1)
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1
University College Hospital
London, United Kingdom, WC1E 6DB