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Efficacy of Vivomixx on Behaviour and Gut Function in Autism Spectrum Disor... | Recruiting
Efficacy of Vivomixx on Behaviour a... | Recruiting
Efficacy of Vivomixx on Behaviour and Gut Function in Autism Spectrum Disorder
VIVO-ASD

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Medical Conditions
  • Autism Spectrum Disorder
Primary Contact Details
Susan D Simmons, BSc Hons
+44 7952961881
See all trial contact details
Recruitment Status
Recruiting
Trial source and source ID number
NCT03369431
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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.
Research Details
  • 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 Treating 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 recruitment poster and asked to contact the investigators if they wish their child to be considered for the study.

    Parents who respond to the recruitment poster will be emailed the Patient Information Sheet and the Child Information Leaflet. A few days later, they will then be emailed to ask if they are interested in answering some questions to see if their child is eligible for the study. If they are, an appointment will be made to phone them and complete the screening questionnaire. For those children that fit the requirements for the trial, the parents will be invited for their child to take part. The investigators will ask for their consent to contact their General Practitioner (GP) for a referral to the Principal Investigator of the study. The participants recruited to the study will be allocated at random to either group A or B and will be given a unique Study Number. All data collected throughout the study will be anonymised and identified only by the participant's study number.

    The first week of study will be a taste evaluation of the product for all participants (both groups). The taste evaluation is to ensure that the participant finds the taste acceptable and is willing to take the treatment product. For those that find the taste acceptable they will then either receive a 12-week course of Vivomixx probiotic or a 12-week course of the placebo powder, according to their random group allocation. The placebo powder has the same look and taste as Vivomixx.

    Once the participant has passed the taste evaluation, the child's educator will be sent a letter inviting them to participate in the study. Included with this letter will be a consent slip, a copy of the Educator Questionnaire and a stamped addressed envelope for returning the questionnaires and consent slip to the researcher.

    All participants' parents will be phoned by the researcher in Weeks 5 and 9 to adjust the treatment dose, offer support and check compliance.

    Those parents whose child is eligible but who choose not to take part will be asked for the main reason and this will be logged in the screening log of patients.

    After 12 weeks there will be 4 weeks when neither group is taking any treatment (a washout period). After this, participants who complete all 12 weeks of the double-blind treatment period will be eligible to enter the double-blind 12-week withdrawal period. The participants that have been taking the placebo will then receive a 12-week course of Vivomixx probiotic. The participants that have received Vivomixx, will take a 12-week course of the placebo. All participants' parents will be phoned by the researcher in Weeks 21 and 25 to adjust the treatment dose, offer support and check compliance. We will also ask about their experience of the study.

    The investigators are primarily interested in whether participants in the intervention group (Vivomixx) have had more of an improvement in their overall function after their 12-week course of Vivomixx compared to that of the control group (receiving the placebo). The investigators will also measure the effect of the active treatment on parent stress compared to the control group and the effect of the active treatment on gastrointestinal symptoms and clinician's global assessment compared to the control group.

    During the study the investigators will assess how well the participants kept to the treatment plan. The investigators will also record changes that happen during the trial that may affect the efficacy of treatment, for example taking antibiotics or a significant change in diet. The investigators will talk to the participant's parents to find how they perceived the treatment and how their child tolerated the treatment.

    Statistical methodology and analysis The intention-to-treat (ITT) analysis will be performed on all participants who are randomised. An additional analysis will be done on only those participants who complete the study per protocol analysis. Changes in ASD scores during follow-up will be examined using the mixed model for analysis of variance to account for missing data (dropouts). The mixed model will use group (treatment versus control) and time as factors. If residuals prove not to be normally distributed the Bonferroni multiple comparisons with Bootstrap multiple comparisons to accommodate for the non-normality of residuals will be done. A P-value less than 0.05 is considered significant and multiple comparisons will be undertaken with Fisher's least significant difference test and 95 percent confidence intervals.
Phase
N/A
Study Design
Sorry, this information is not available
Study Type
Interventional
Intervention
Dietary Supplement : Vivomixx, Dietary Supplement : Placebo

Study Arm Groups : Group A, Group B, Group A, Group B

Intervention Type
See Interventions above
Primary Outcome Measures
    A change in the Autism Treatment Evaluation Checklist (ATEC) total score compared to baseline.; 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 Outcome Measures
    A 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) total score compared to baseline.; ABC 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.; A 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.
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
All
Age Range
3 Years - 16 Years
Who Can Participate
Patients
Number of Participants
82
Participant Inclusion 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) or Developmental, Dimensional and Diagnostic Interview (3di).

    - 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
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
London
WC1E 6DB
Trial Contact(s)
Primary Trial Contact
Susan D Simmons, BSc Hons
+44 7952961881
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
The Efficacy of the Multistrain Probiotic, Vivomixx, on Behaviour and Gastrointestinal Symptoms in Children With Autism Spectrum Disorder (ASD)
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
17/0148
Sponsor(s)
University College, London
Key Dates

Recruitment Start Date

Feb 2018

Recruitment End Date

Dec 2019

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

27 Nov 2017

Date updated in source

04 Apr 2019