Autism Spectrum Disorder Clinical Trial
— VIVO-ASDOfficial title:
The Efficacy of the Multistrain Probiotic, Vivomixx, on Behaviour and Gastrointestinal Symptoms in Children With Autism Spectrum Disorder (ASD)
Verified date | November 2021 |
Source | University College, London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 69 |
Est. completion date | January 29, 2021 |
Est. primary completion date | October 2, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Years to 16 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | University College Hospital | London |
Lead Sponsor | Collaborator |
---|---|
University College, London |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | A Change in the Autism Treatment Evaluation Checklist (ATEC) Total Score Compared to Baseline. | The ATEC is a one-page form, designed to be completed by parents, teachers, or caregivers. It consists of 4 subtests: I. Speech/Language Communication (14 items); II. Sociability (20 items); III. Sensory/ Cognitive Awareness (18 items); and IV. Health/Physical/Behavior (25 items). The scale covers 77 items and gives a total score and scores for each of the 4 sub-sections. The higher the score, the greater the impairment overall or in a sub-section. The ATEC total score can range from 0 - 180 and is calculated by summing the scores of each subsection. | ATEC will be measured at the time of enrolment to the study, after the first 12-week treatment and after the second 12-week treatment by the child's primary carer and also by the child's educator. | |
Secondary | The Change in the Frequency of Gastrointestinal Symptoms Compared to Baseline, as Measured by the Gastrointestinal History (GIH) Questionnaire. | In 2003 the Childhood Autism Risks from Genetics and the Environment (CHARGE) study developed and began using a frequency assessment of GI symptoms in autistic children, which they called the Gastrointestinal History Questionnaire. The Gastrointestinal History questionnaire (GIH) includes 10 Likert scale items for the following symptoms: abdominal pain, gaseousness/bloating sensation, diarrhoea, constipation, pain on stooling, vomiting, difficulty swallowing, blood in stools and blood in vomit. These have been equated to a numerical score as follows; never=0, rarely=1, sometimes=2, frequently=3, always=4. | GIH will be measured at the time of enrolment to the study, after the first 12-week treatment and after the second 12-week treatment. | |
Secondary | A Change in the Aberrant Behaviour Checklist (ABC) Section Scores Compared to Baseline. | Maladaptive behavior will be measured using five subscales of the ABC: Irritability (15 items), Lethargy/social withdrawal (16 items), Stereotypic behaviour (7 items), Hyperactivity/Noncompliance (16 items) and Inappropriate speech (4 items). A higher score indicates greater difficulty. The minimum score for each section is 0. The maximum scores for the sections are: Irritability 45, Lethargy/social withdrawal 48, Stereotypic behaviour 21, Hyperactivity/Noncompliance 48 and Inappropriate speech 12. | ABC was measured at the time of enrolment to the study, after the first 12-week treatment and after the second 12-week treatment by the child's primary carer. | |
Secondary | The Change in the Autism Parenting Stress Index (APSI) Score Compared to Baseline. | This one-page, self-assessment questionnaire was developed and validated in 2012. It is designed to assess parent stress in 13 aspects of autism of concern to parents and to provide a measure of parenting stress specific to core symptoms of autism and common co-occurring issues. It reflects the time, effort and actual difficulty of parenting in the light of the physical, social and communication barriers imposed by autism. It is intended for use by clinicians to assess the effects of an intervention on parenting stress. A higher score indicates greater parenting stress. The minimum score is 0 and the maximum score is 65. | APSI will be measured at the time of enrolment to the study, after the first 12-week treatment and after the second 12-week treatment. |
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