A Study on Probiotic Formula in Autistic Children

Third Military Medical University

Status: Not yet enrolling

Conditions: Autism Spectrum Disorder

Treatments: Other: Probiotic formula capsule; Other: placebo capsule; Other: FMT capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT06419530

TMMU-DP-ASD-PMT-20240510

Details and patient eligibility

About

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

Full 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.

Enrollment: 156 estimated patients

Sex: All

Ages: 3 to 14 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children and adolescents aged 3-11 years old
• Clinical diagnosis of ASD, based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-V)
• Associated with gastrointestinal symptoms for at least 14 days (diarrhea, constipation, abdominal pain, bloating and/or food allergies/intolerances)
• With guardians who can fully understand the informed consent and voluntarily sign the written informed consent

Exclusion criteria

• Antibiotics or probiotics used within 1 mont
• Serious gastrointestinal problems that require immediate treatment (such as life-threatening intestinal obstruction, intestinal perforation, intestinal bleeding
• Medications related to mental disorders or depression
• Relying on tube feeding
• Swallowing dysfunction that unable to take capsules
• History of severe allergies
• Paticipation in other clinical studies within 4 weeks
• Poor compliance and have difficulty in completing follow-up.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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156 participants in 3 patient groups, including a placebo group

Placebo group

Placebo Comparator group

Description:

In this arm, 4 placebo capsules would be oral administered by participants everyday for 84 days.

Treatment:

Other: placebo capsule

Fecal microbiota transplantation (FMT) group

Active Comparator group

Description:

In this arm, 4 FMT capsules would be oral administered by participants everyday for 84 days.

Treatment:

Other: FMT capsule

Probiotic formula group

Experimental group

Description:

In this arm, 4 Probiotic formula capsules would be oral administered by participants everyday for 84 days.

Treatment:

Other: Probiotic formula capsule