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Trial record 86 of 593 for:    maltodextrin

Prebiotic Intervention for Autism Spectrum Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02720900
Recruitment Status : Completed
First Posted : March 28, 2016
Last Update Posted : February 15, 2018
University of Reading
Information provided by (Responsible Party):
Clasado Limited

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.

Condition or disease Intervention/treatment Phase
Autism Dietary Supplement: B-GOS Dietary Supplement: Maltodextrin Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of a Prebiotic (B-GOS) Supplementation on Microbiota and Gastrointestinal (GI) Symptoms in Children With Autism Spectrum Disorders (ASD)
Actual Study Start Date : September 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Maltodextrin
powder, 1.8g/day
Dietary Supplement: Maltodextrin
1.8 g/day for 6 weeks
Other Name: Corn Starch

Active Comparator: B-GOS
powder, 1.8g/day
Dietary Supplement: B-GOS
1.8 g/day for 6 weeks
Other Name: Bimuno

Primary Outcome Measures :
  1. effect on faecal microbiota composition using pyrosequencing [ Time Frame: change from baseline in microbiota composition to the end of treatment (6 months) ]
    using pyrosequencing

  2. 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

Secondary Outcome Measures :
  1. questionnaire as a measure of bowel function [ Time Frame: measured weekly for 6 months ]
    using weekly scores on questions related to stool consistency, frequency, abdominal pain and bloating

  2. questionnaire as a measure of mood [ Time Frame: monthly for 6 months ]
    using monthly scores on questions related to mood and sleep patterns

  3. questionnaire as a measure of behaviour [ Time Frame: monthly for 6 months ]
    using monthly scores on questions related to behaviour

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   5 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02720900

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United Kingdom
University of Reading
Reading, Berks, United Kingdom
Sponsors and Collaborators
Clasado Limited
University of Reading
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Study Chair: Jelena Vulevic, phd Clasado Research Services

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Clasado Limited Identifier: NCT02720900     History of Changes
Other Study ID Numbers: ASD2015
First Posted: March 28, 2016    Key Record Dates
Last Update Posted: February 15, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: upon completion of the whole study, volunteers will be able to access their individual data following written request
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders