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Trial record 1 of 1 for:    NCT03369431
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Efficacy of Vivomixx on Behaviour and Gut Function in Autism Spectrum Disorder (VIVO-ASD)

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ClinicalTrials.gov Identifier: NCT03369431
Recruitment Status : Completed
First Posted : December 12, 2017
Results First Posted : February 14, 2022
Last Update Posted : March 8, 2022
Sponsor:
Information provided by (Responsible Party):
University College, London

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 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.


Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Dietary Supplement: Vivomixx Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 3-month randomised controlled cross-over design with 4-week washout. Outcomes measured at baseline and last week of each treatment phase.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy of the Multistrain Probiotic, Vivomixx, on Behaviour and Gastrointestinal Symptoms in Children With Autism Spectrum Disorder (ASD)
Actual Study Start Date : February 1, 2018
Actual Primary Completion Date : October 2, 2020
Actual Study Completion Date : January 29, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Vivomixx, then placebo
This group starts with Vivomixx probiotic for the first 12 weeks then crosses over to have the placebo after a 4-week washout.
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

Placebo, then Vivomixx
This group starts with the placebo for the first 12 weeks then crosses over to have Vivomixx probiotic after a 4-week washout.
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




Primary Outcome Measures :
  1. A Change in the Autism Treatment Evaluation Checklist (ATEC) Total Score Compared to Baseline. [ Time Frame: 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. ]
    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.


Secondary Outcome Measures :
  1. The Change in the Frequency of Gastrointestinal Symptoms Compared to Baseline, as Measured by the Gastrointestinal History (GIH) Questionnaire. [ Time Frame: 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. ]
    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.

  2. A Change in the Aberrant Behaviour Checklist (ABC) Section Scores Compared to Baseline. [ Time Frame: 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. ]
    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.

  3. The Change in the Autism Parenting Stress Index (APSI) Score Compared to Baseline. [ Time Frame: 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. ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03369431


Locations
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United Kingdom
University College Hospital
London, United Kingdom, WC1E 6DB
Sponsors and Collaborators
University College, London
Investigators
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Principal Investigator: Anton V Emmanuel, MBBS, FRCP University College, London
  Study Documents (Full-Text)

Documents provided by University College, London:
Study Protocol  [PDF] January 30, 2020
Statistical Analysis Plan  [PDF] March 18, 2021

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Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT03369431    
Other Study ID Numbers: 17/0148
First Posted: December 12, 2017    Key Record Dates
Results First Posted: February 14, 2022
Last Update Posted: March 8, 2022
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University College, London:
Autism
Gastrointestinal
behaviour
constipation
diarrhoea
probiotic
sociability
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders