N/A
Completed N=69
Efficacy of Vivomixx on Behaviour and Gut Function in Autism Spectrum Disorder
Source: ClinicalTrials.gov NCT03369431 ↗Enrolled (actual)
69
Serious AEs
0.0%
Results posted
Feb 2022
Primary outcomePrimary: A Change in the Autism Treatment Evaluation Checklist (ATEC) Total Score Compared to Baseline. — -12.122; -11.427 percentage change from baseline score — p=0.784
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY A Change in the Autism Treatment Evaluation Checklist (ATEC) Total Score Compared to Baseline. |
-12.122; -11.427 | 0.784 |
| SECONDARY The Change in the Frequency of Gastrointestinal Symptoms Compared to Baseline, as Measured by the Gastrointestinal History (GIH) Questionnaire. |
-0.92; -0.82; -0.70; -0.86; -0.92; -0.80 | 0.357 |
| SECONDARY A Change in the Aberrant Behaviour Checklist (ABC) Section Scores Compared to Baseline. |
-3.00; -3.05; -2.26; -3.11; -1.06; -1.08 | 0.635 |
| SECONDARY The Change in the Autism Parenting Stress Index (APSI) Score Compared to Baseline. |
-3.73; -3.11 | 0.661 |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03369431). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.