NCT06419530

A Study on Probiotic Formula in Autistic Children

A Double-blind Randomized Clinical Trail Study on the Effectiveness and Safety of Probiotic Formula in Autistic Children With Gastrointestinal Symptoms

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 156 (estimated)
• Sponsor: Third Military Medical University · Academic / Other
• Sex: All
• Age: 3 Years – 14 Years
• Healthy volunteers: Not accepted

Summary

A Randomized controlled double-blind clinical study on the effectiveness and safety of probiotic formula in Autistic children with gastrointestinal symptoms.

Detailed description

Autism spectrum disorder (ASD) is a neurodevelopmental disorder of children with estimated prevalence of near 1% by WHO in 2022. To date, the cause and etiology of ASD is still unknown, and there is no proven effective pharmacological treatment for ASD. The gut microbiota has been proved to have great impact on neurological development, in this study, we aim to explore the effectiveness of safety of probiotic formula on ASD children, by comparing with placebo and fecal microbiota transplantation (FMT). This study will be a randomized, double-blind, placebo-controlled trial. Totally, 156 Autistic children with gastrointestinal symptoms will be enrolled and randomly allocated into three groups: probiotic formula group, fecal microbiota transplantation (FMT) group and placebo group. participants are treated with 4 probiotic formula/FMT/placebo capsules each day, for 84 days. Participants would be followed up at the 4th, 8th, 12th and 24th week after enrollment by simple physical examination, relevant scale questionaire (including Autism Behavior Checklist(ABC),Childhood Autism Rating Scale(CARS),Gastrointestinal Symptom Rating Scale(GSRS),Social Responsiveness Scale(SRS),Self-Rating Anxiety Scale(SAS) and Autism Diagnostic Observation Schedule(ADOS)), and blood and fecal samples collection.

Conditions

• Autism Spectrum Disorder

Interventions

Type	Name	Description
OTHER	Probiotic formula capsule	The subjects take 4 capsules a day for 84 days.
OTHER	placebo capsule	The subjects take 4 capsules a day for 84 days.
OTHER	FMT capsule	The subjects take 4 capsules a day for 84 days.

Timeline

• Start date: 2024-06-01
• Primary completion: 2027-06-01
• Completion: 2028-06-01
• First posted: 2024-05-17
• Last updated: 2024-05-23

Locations

1 site across 1 country: China