Combined Human Milk Oligosaccharides (HMOs) and Probiotics Intervention for Children With Autism

NCT05151601 | Unknown DMC

• 1 other identifier: 2020-11-30-Auts
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This research project will investigate if a supplement containing a unique combination of prebiotics and probiotics can influence behaviour in children diagnosed with autism spectrum disorder. The study will use a combination of human milk oligosaccharides (HMOs, prebiotics) and probiotics as an oral powder.This clinical trial will have two consecutive phases. Phase 1A is an 8-week randomised, double-blinded, placebo-controlled trial. Participants will be recruited and randomised (1:1) to receive either the investigational product (treatment group, n=30) or the placebo (control group, n=30). Phase 1B is an 8-week open-label study. All participants that complete Phase 1A will move into Phase 1B (n=60). This allows all participants to receive the investigational product and will provide additional information on increased duration of treatment.

Conditions

Autism Spectrum Disorder; Neurodevelopmental Disorders; Anxiety

Keywords

Gut microbiome; Behaviour

Outcome Measures

Primary Outcomes (3)

• Behaviour change

  Changes in behavioural symptoms as measured by the Irritability sub-scale of the Aberrant Behavior Checklist - Community (Version 2) (I-ABC). The ABC 58-item parent-rated questionnaire and consists of five subscales, including: 1) irritability (15 items); 2) lethargy/social withdrawal (16 items); 3) stereotypic behaviour (7 items); 4) hyperactivity/noncompliance (16 items); and 5) inappropriate speech (4 items). Each item is scored as 0=never a problem, 1=slight problem, 2=moderately serious problem, or 3=severe problem. The score range is 0-174, with a higher score indicating greater severity or difficulties.

  Baseline, Phase IA midpoint (week 4) and post-Phase 1A(week 8/9), post-Phase 1B (week 17/18)

• Behaviour Change

  Changes in behavioural symptoms as measured by the Home Situations Questionnaire - Autism Spectrum Disorder (HSQ-ASD). The HSQ-ASD is a 24-item, parent-rated measure of non compliant behaviour in children with ASD. The scale yields per-item mean scores of 0 to 9, with higher scores indicating greater noncompliance.

  Baseline, Phase 1A midpoint (week 4) and post-Phase 1A (week 8/9)

• Behaviour Change

  Changes in parent/guardian targeted behaviours as measured by the Parent Targeted Symptom Visual Analogue Scale (PTSVAS). The PTSVAS tool requests parents/guardians report their top three (3) target behaviours (behaviours of concern) on a Visual Analogue Scale (VAS). The VAS is a horizontal line of 100mm in length, with each end defined as the extreme limits of the behaviour of concern ("best" to "worst"), to be measured from left to right. The parents will score the behaviour by placing a mark on the VAS at baseline and post-intervention. Each mark will be measured on the scale of 0-100mm and the change from baseline to post-intervention noted.

  Baseline and post-Phase 1A (week 8/9)

Secondary Outcomes (8)

• Change in GI Symptom Severity

  Baseline and post-Phase 1A (week 8/9)

• Change in the Gut Microbiome

  Baseline and post-Phase 1A (week 8/9)

• Change in Anxiety Levels

  Baseline and post-Phase 1A (week 8/9)

• Change in Quality of Life

  Baseline and post-Phase 1A (week 8/9)

• Change in Stool Consistency

  Baseline, Phase A1 midpoint (week 4), and post-Phase 1A (week 8/9), post-Phase 1B (week 17/18) .

Study Arms (2)

HMOs + Probiotics

EXPERIMENTAL

Dosing: A total daily dose of 2 x sachets (6g/day) Product Comprised of: 1. 2.5g of a proprietary blend of human milk oligosaccharides combined with 2. 20 billion CFUs of a mixture of Lactobacillus rhamnosus, Lactobacillus plantarum, Bifidobacterium animalis spp. lactis, and Bifidobacterium longum. Mode of administration: oral.

Dietary Supplement: Experimental

Placebo

PLACEBO COMPARATOR

Dosing: A total daily dose of 2 x sachets (6g/day)u (8 weeks of phase 1A). Product: powdered maltodextrin. Mode of administration: oral.

Other: Placebo

Interventions

Experimental DIETARY_SUPPLEMENT

2 x sachets per day

HMOs + Probiotics

Placebo OTHER

2 x sachets per day

Placebo

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Aged 5.00 years to 12.99 years.
• A confirmed diagnosis of ASD or Pervasive Developmental Disorders (PDD) including autistic disorder, Asperger's disorder (AS); PDD not otherwise specified (PDD-NOS); and atypical autism.

You may not qualify if:

• Organic GI disorders such as inflammatory bowel disease, coeliac disease, eosinophilic disorders, or current infection of the GI tract.
• Bowel surgery or short bowel syndrome
• Participants who have a diagnosed cow milk protein allergy.
• Participants who suffer from the conditions listed below or who are taking any of the following medications or supplements:
• antibiotics or antifungals in the last two months
• probiotic supplements in the last two months
• immunocompromised or severely ill
• genetic disorders (e.g. Fragile X Syndrome)
• chronic health conditions such as diabetes, heart disease or an eating disorder.

Sponsors & Collaborators

• The University of Queensland: lead

Study Sites (1)

University of Queensland, Child Health Research Centre

Brisbane, Queensland, 4001, Australia

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Neurodevelopmental Disorders; Anxiety Disorders; Behavior

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Mental Disorders

Study Officials

• Peter SW Davies, PhD

  The University of Queensland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be recruited into a two-phase project. Phase 1A: an 8-week double-blinded, placebo-controlled, randomised trial. Participants child will be randomised to one of groups 1) treatment (HMOs/Probiotic group) or 2) control group (placebo product). Phase 1B: is an 8-week open-label trial. All children who successfully complete phase 1A will be recruited into phase 1B. All participants in phase 1B will receive the treatment product (HMOs/probiotics). Follow up will occur at week 8 and week 17.

Study Record Dates

• First Submitted: October 17, 2021
• First Posted: December 9, 2021
• Study Start: May 17, 2022
• Primary Completion: April 16, 2023
• Study Completion: December 31, 2023
• Last Updated: June 28, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)