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

The University of Queensland

Status: Active, not recruiting

Conditions: Autism Spectrum Disorder; Neurodevelopmental Disorders; Anxiety

Treatments: Other: Placebo; Dietary Supplement: Experimental

Study type: Interventional

Funder types: Other

Identifiers

NCT05151601

2020-11-30-Auts

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 5 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Aged 5.00 years to 12.99 years.
2. 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.

Exclusion criteria

1. Organic GI disorders such as inflammatory bowel disease, coeliac disease, eosinophilic disorders, or current infection of the GI tract.

2. Bowel surgery or short bowel syndrome

3. Participants who have a diagnosed cow milk protein allergy.

4. 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 2 patient groups, including a placebo group

HMOs + Probiotics

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Experimental

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo