NCT02720900

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 10, 2015

Completed
5 months until next milestone

First Posted

Study publicly available on registry

March 28, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

February 15, 2018

Status Verified

February 1, 2018

Enrollment Period

1 year

First QC Date

November 10, 2015

Last Update Submit

February 14, 2018

Conditions

Autism

Outcome Measures

Primary Outcomes (2)

  • effect on faecal microbiota composition using pyrosequencing

    using pyrosequencing

    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

    change from baseline in microbiota activity to the end of treatment (6 months)

Secondary Outcomes (3)

  • questionnaire as a measure of bowel function

    measured weekly for 6 months

  • questionnaire as a measure of mood

    monthly for 6 months

  • questionnaire as a measure of behaviour

    monthly for 6 months

Study Arms (2)

Maltodextrin

PLACEBO COMPARATOR

powder, 1.8g/day

Dietary Supplement: Maltodextrin

B-GOS

ACTIVE COMPARATOR

powder, 1.8g/day

Dietary Supplement: B-GOS

Interventions

B-GOSDIETARY_SUPPLEMENT

1.8 g/day for 6 weeks

Also known as: Bimuno
B-GOS
MaltodextrinDIETARY_SUPPLEMENT

1.8 g/day for 6 weeks

Also known as: Corn Starch
Maltodextrin

Eligibility Criteria

Age5 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Reading

Reading, Berks, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 30071894DERIVED

MeSH Terms

Conditions

Autistic Disorder

Interventions

maltodextrinStarch

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

GlucansBiopolymersPolymersMacromolecular SubstancesDietary CarbohydratesCarbohydratesPolysaccharides

Study Officials

  • Jelena Vulevic, phd

    Clasado Research Services

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2015

First Posted

March 28, 2016

Study Start

September 1, 2015

Primary Completion

September 1, 2016

Study Completion

May 1, 2017

Last Updated

February 15, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will share

upon completion of the whole study, volunteers will be able to access their individual data following written request

Locations

GB(1)