Prebiotic Intervention for Autism Spectrum Disorders
Primary Purpose
Autism
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
B-GOS
Maltodextrin
Sponsored by
About this trial
This is an interventional treatment trial for Autism
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- University of Reading
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Maltodextrin
B-GOS
Arm Description
powder, 1.8g/day
powder, 1.8g/day
Outcomes
Primary Outcome Measures
effect on faecal microbiota composition using pyrosequencing
using pyrosequencing
effect on faecal microbiota activity using nuclear magnetic resonance spectroscopy
using nuclear magnetic resonance spectroscopy
Secondary Outcome Measures
questionnaire as a measure of bowel function
using weekly scores on questions related to stool consistency, frequency, abdominal pain and bloating
questionnaire as a measure of mood
using monthly scores on questions related to mood and sleep patterns
questionnaire as a measure of behaviour
using monthly scores on questions related to behaviour
Full Information
NCT ID
NCT02720900
First Posted
November 10, 2015
Last Updated
February 14, 2018
Sponsor
Clasado Limited
Collaborators
University of Reading
1. Study Identification
Unique Protocol Identification Number
NCT02720900
Brief Title
Prebiotic Intervention for Autism Spectrum Disorders
Official Title
Effect of a Prebiotic (B-GOS) Supplementation on Microbiota and Gastrointestinal (GI) Symptoms in Children With Autism Spectrum Disorders (ASD)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
September 2015 (Actual)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
May 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clasado Limited
Collaborators
University of Reading
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Maltodextrin
Arm Type
Placebo Comparator
Arm Description
powder, 1.8g/day
Arm Title
B-GOS
Arm Type
Active Comparator
Arm Description
powder, 1.8g/day
Intervention Type
Dietary Supplement
Intervention Name(s)
B-GOS
Other Intervention Name(s)
Bimuno
Intervention Description
1.8 g/day for 6 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Maltodextrin
Other Intervention Name(s)
Corn Starch
Intervention Description
1.8 g/day for 6 weeks
Primary Outcome Measure Information:
Title
effect on faecal microbiota composition using pyrosequencing
Description
using pyrosequencing
Time Frame
change from baseline in microbiota composition to the end of treatment (6 months)
Title
effect on faecal microbiota activity using nuclear magnetic resonance spectroscopy
Description
using nuclear magnetic resonance spectroscopy
Time Frame
change from baseline in microbiota activity to the end of treatment (6 months)
Secondary Outcome Measure Information:
Title
questionnaire as a measure of bowel function
Description
using weekly scores on questions related to stool consistency, frequency, abdominal pain and bloating
Time Frame
measured weekly for 6 months
Title
questionnaire as a measure of mood
Description
using monthly scores on questions related to mood and sleep patterns
Time Frame
monthly for 6 months
Title
questionnaire as a measure of behaviour
Description
using monthly scores on questions related to behaviour
Time Frame
monthly for 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jelena Vulevic, phd
Organizational Affiliation
Clasado Research Services
Official's Role
Study Chair
Facility Information:
Facility Name
University of Reading
City
Reading
State/Province
Berks
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
upon completion of the whole study, volunteers will be able to access their individual data following written request
Citations:
PubMed Identifier
30071894
Citation
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.
Results Reference
derived
Learn more about this trial
Prebiotic Intervention for Autism Spectrum Disorders
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