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

NCT03369431 | Completed Results DMC

• 1 other identifier: 17/0148
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Keywords

Autism; Gastrointestinal; behaviour; constipation; diarrhoea; probiotic; sociability

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The Change in the Frequency of Gastrointestinal Symptoms Compared to Baseline, as Measured by the Gastrointestinal History (GIH) Questionnaire.

  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.

• A Change in the Aberrant Behaviour Checklist (ABC) Section Scores Compared to Baseline.

  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.

• The Change in the Autism Parenting Stress Index (APSI) Score Compared to Baseline.

  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.

Study Arms (2)

Vivomixx, then placebo

OTHER

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; Dietary Supplement: Placebo

Placebo, then Vivomixx

OTHER

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; Dietary Supplement: Placebo

Interventions

Vivomixx DIETARY_SUPPLEMENT

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.

Placebo, then Vivomixx; Vivomixx, then placebo

Placebo DIETARY_SUPPLEMENT

4.4 grams of maltose and silicon dioxide per sachet

Placebo, then Vivomixx; Vivomixx, then placebo

Eligibility Criteria

• Age: 3 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

University College Hospital

London, WC1E 6DB, United Kingdom

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder; Behavior; Constipation; Diarrhea

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Too few ATEC and ABC questionnaires were completed by educators to enable analysis. Stool sample collection was disrupted by Covid-19 lockdown and consequently there were insufficient samples for analysis.

Results Point of Contact

• Title: Susan Simmons
• Organization: University College London

susan.simmons.16@ucl.ac.uk

+44 7952961881

Study Officials

• Anton V Emmanuel, MBBS, FRCP

  University College, London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 3-month randomised controlled cross-over design with 4-week washout. Outcomes measured at baseline and last week of each treatment phase.

Study Record Dates

• First Submitted: November 27, 2017
• First Posted: December 12, 2017
• Study Start: February 1, 2018
• Primary Completion: October 2, 2020
• Study Completion: January 29, 2021
• Last Updated: March 8, 2022
• Results First Posted: February 14, 2022

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)