ASD-Probiotic V.1
Research type
Research Study
Full title
An investigation of the parent-observed link between behaviour symptoms and the dietary management of gastrointestinal symptoms in children with autism spectrum disorder. Can gastrointestinal symptoms be managed by dietary intervention and does this bring benefits to children with autism spectrum disorder (ASD) and their families, over and above improvement in gastrointestinal (GI) symptoms?
IRAS ID
204582
Contact name
Anton Emmanuel
Contact email
Sponsor organisation
University College London
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Summary of Research
This research aims to find out whether Vivomixx probiotic can improve the overall function and GI symptoms of children with Autistic Spectrum Disorders (ASD). Participants will be allocated at random to one of 2 groups. Both groups will do a 1-week taste evaluation. Those that tolerate the taste will progress to the next phase. In phase 2, one group will receive a 12-week course of Vivomixx probiotic and the other will receive a 12-week course of placebo powder. After 12 weeks there will be 4 weeks when neither group is taking any treatment. Patients who complete all 12 weeks of the treatment period will be eligible to enter the 12-week withdrawal period. The participants that have been taking the placebo powder will receive a 12-week course of Vivomixx probiotic and vice versa. We will measure the results of treatment after 12 weeks and 28 weeks. We are primarily interested in whether patients 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). We will also measure the effect of the active treatment on parent stress compared to the control group, the effect of the active treatment on gastrointestinal symptoms and aberrant behaviour compared to the control group and the effect on the clinician's global assessment. We will collect stool samples after enrolment, after the first 12-week treatment and after the second 12-week treatment to assess whether treatment has made a change in the gut microbiota.
Summary of Results
Analysis of the study data for all the participants has shown no statistically significant differences on the measures of gastrointestinal symptoms or overall health and functioning when comparing Vivomixx probiotic to placebo. This means that in autistic children aged 3 to 16, with at least one gastrointestinal symptom (constipation, diarrhoea, abnormal stools, very odorous stools, abdominal pain, gaseousness or bloating, pain on defecation, reflux) persisting for six months, Vivomixx did not significantly reduce the frequency of gastrointestinal symptoms or improve global functioning when compared to placebo. It is possible that there are some children who benefited from the treatment, but the averaged data for the whole group did not show any difference.
This study indicated that the safety of Vivomixx is good in this patient group with no serious adverse events reported and a slightly lower chance of any adverse event with Vivomixx compared to with placebo.
REC name
London - Chelsea Research Ethics Committee
REC reference
17/LO/1458
Date of REC Opinion
1 Nov 2017
REC opinion
Further Information Favourable Opinion