AutismNCT02720900
Prebiotic Intervention for Autism Spectrum Disorders
A study testing B-GOS and Maltodextrin in people with Autism, run by Clasado Limited at 1 site in United Kingdom.
Trial summary
The purpose of this study is to determine the effect of a prebiotic (BGOS) on gut microbiota and metabolites in children with autism spectrum disorders. Read more about this study
- Who is it for?
- Ages 5 to 10 years
- Conditions the study is for
- Autism
- What is being tested?
- B-GOS and Maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2015to May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children aged 5-10 years with formal ASD diagnosis
- children's parent or guardian has given written informed consent to participate and is willing to participate in the entire study
Who cannot join
- consumption of antibiotics, prebiotic or probiotics in the last 4 weeks prior to or during the study
- participants who have received bowel preparation for investigative procedures in the 4 weeks prior to the study
- undergone surgical resection of any part of the bowel
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Prebiotic (B-GOS) Supplementation on Microbiota and Gastrointestinal (GI) Symptoms in Children With Autism Spectrum Disorders (ASD)
The purpose of this study is to determine the effect of a prebiotic (BGOS) on gut microbiota and metabolites in children with autism spectrum disorders.
Read the detailed description
Children with ASD have a higher incidence of dietary and/or bowel problems than typically developing children. it has been postulated that imbalances in the gut bacteria and/or metabolites present in the gut may be a contributing factor to these symptoms, with potentially bad (toxin-producing) bacteria colonising the gut. Certain carbohydrates (so-called 'prebiotics') are not digested by the human gut and they provide food for beneficial bacteria and thus they improve the composition by preventing the growth of bad bacteria. Individuals could therefore benefit from these safe and effective dietary interventions to maintain the healthy gut bacteria and overall health. This study is being carried out to establish the effect of one such prebiotic, called galactooligosaccharide (B-GOS) on the relative balance of gut bacteria and metabolites in children with ASD. The aim is to enrol 42 children, ages 5-10 with formal ASD diagnosis and with signed informed consent from their parents, into double-blind, placebo controlled, parallel study. The trial will last 10 weeks in total (2 weeks run in period, 6 weeks treatment and 2 weeks follow up). Children will be required to take food supplement daily during the treatment period and their parents will collect stool, saliva and urine samples. Various questionnaires will also be used for assessments. Children will not be required to make other extra changes to their diet, medication or lifestyle.
- Conditions
- Autism
- Being tested
- B-GOS, Maltodextrin
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B-GOSDietary supplement
Also called Bimuno
1.8 g/day for 6 weeks
MaltodextrinDietary supplement
Also called Corn Starch
1.8 g/day for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Maltodextrin | Placebo comparator | powder, 1.8g/day Receives: Dietary Supplement: Maltodextrin |
| B-GOS | Active comparator | powder, 1.8g/day Receives: Dietary Supplement: B-GOS |
What is being measured
The primary outcome is the main question the study is designed to answer.
effect on faecal microbiota composition using pyrosequencing
using pyrosequencing
Measured: change from baseline in microbiota composition to the end of treatment (6 months)
effect on faecal microbiota activity using nuclear magnetic resonance spectroscopy
using nuclear magnetic resonance spectroscopy
Measured: change from baseline in microbiota activity to the end of treatment (6 months)
Secondary outcomes (3)
questionnaire as a measure of bowel function
using weekly scores on questions related to stool consistency, frequency, abdominal pain and bloating
Measured: measured weekly for 6 months
questionnaire as a measure of mood
using monthly scores on questions related to mood and sleep patterns
Measured: monthly for 6 months
questionnaire as a measure of behaviour
using monthly scores on questions related to behaviour
Measured: monthly for 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2016 (estimated)
- Study startSep 2015
- Primary completionSep 2016
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AutismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clasado Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Reading
- Responsible party
- Sponsor
- Investigators
- Jelena Vulevic, phd, Study chair, Clasado Research Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02720900
- Sponsor's protocol ID
- ASD2015
- Status last verified
- Feb 2018
- First submitted
- 10 Nov 2015
- Last updated
- 15 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: upon completion of the whole study, volunteers will be able to access their individual data following written request
Publications
Grimaldi R, Gibson GR, Vulevic J, Giallourou N, Castro-Mejia JL, Hansen LH, Leigh Gibson E, Nielsen DS, Costabile A. A prebiotic intervention study in children with autism spectrum disorders (ASDs). Microbiome. 2018 Aug 2;6(1):133. doi: 10.1186/s40168-018-0523-3.
PubMed 30071894
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Prebiotic (B-GOS) Supplementation on Microbiota and Gastrointestinal (GI) Symptoms in Children With Autism Spectrum Disorders (ASD)
- ClinicalTrials.gov ID
- NCT02720900
- Acronym / sponsor ID
- ASD2015
- Conditions
- Autism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Clasado LimitedIndustry (pharma, biotech, devices)
- Collaborators
- University of Reading
- Study start
- Sep 2015 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 28 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effect of a prebiotic (BGOS) on gut microbiota and metabolites in children with autism spectrum disorders.
Detailed description
Children with ASD have a higher incidence of dietary and/or bowel problems than typically developing children. it has been postulated that imbalances in the gut bacteria and/or metabolites present in the gut may be a contributing factor to these symptoms, with potentially bad (toxin-producing) bacteria colonising the gut. Certain carbohydrates (so-called 'prebiotics') are not digested by the human gut and they provide food for beneficial bacteria and thus they improve the composition by preventing the growth of bad bacteria. Individuals could therefore benefit from these safe and effective dietary interventions to maintain the healthy gut bacteria and overall health. This study is being carried out to establish the effect of one such prebiotic, called galactooligosaccharide (B-GOS) on the relative balance of gut bacteria and metabolites in children with ASD. The aim is to enrol 42 children, ages 5-10 with formal ASD diagnosis and with signed informed consent from their parents, into double-blind, placebo controlled, parallel study. The trial will last 10 weeks in total (2 weeks run in period, 6 weeks treatment and 2 weeks follow up). Children will be required to take food supplement daily during the treatment period and their parents will collect stool, saliva and urine samples. Various questionnaires will also be used for assessments. Children will not be required to make other extra changes to their diet, medication or lifestyle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maltodextrin | Placebo comparator | Dietary Supplement: Maltodextrinpowder, 1.8g/day |
| B-GOS | Active comparator | Dietary Supplement: B-GOSpowder, 1.8g/day |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- children aged 5-10 years with formal ASD diagnosis
- children's parent or guardian has given written informed consent to participate and is willing to participate in the entire study
Key exclusion criteria (3 listed)
- consumption of antibiotics, prebiotic or probiotics in the last 4 weeks prior to or during the study
- participants who have received bowel preparation for investigative procedures in the 4 weeks prior to the study
- undergone surgical resection of any part of the bowel
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| B-GOSAlso: Bimuno1.8 g/day for 6 weeks | Dietary supplement | B-GOS |
| MaltodextrinAlso: Corn Starch1.8 g/day for 6 weeks | Dietary supplement | Maltodextrin |
Primary outcome
effect on faecal microbiota composition using pyrosequencing
Time frame: change from baseline in microbiota composition to the end of treatment (6 months)
using pyrosequencing
effect on faecal microbiota activity using nuclear magnetic resonance spectroscopy
Time frame: change from baseline in microbiota activity to the end of treatment (6 months)
using nuclear magnetic resonance spectroscopy
3 secondary outcomes
questionnaire as a measure of bowel function
Time frame: measured weekly for 6 months
questionnaire as a measure of mood
Time frame: monthly for 6 months
questionnaire as a measure of behaviour
Time frame: monthly for 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2018.
- Derived from this study: PubMed 30071894Grimaldi R, Gibson GR, Vulevic J, Giallourou N, Castro-Mejia JL, Hansen LH, Leigh Gibson E, Nielsen DS, Costabile A. A prebiotic intervention study in children with autism spectrum disorders (ASDs). Microbiome. 2018 Aug 2;6(1):133. doi: 10.1186/s40168-018-0523-3.
- Individual participant dataSharing planned: Yes. upon completion of the whole study, volunteers will be able to access their individual data following written request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jelena Vulevic, phd study chair
Clasado Research Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing B-GOS and Maltodextrin in people with Autism, run by Clasado Limited at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effect on faecal microbiota composition using pyrosequencing (time frame: change from baseline in microbiota composition to the end of treatment (6 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02720900, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2018.