A Study on Probiotic Formula in Autistic Children

NCT ID: NCT06419530

Last Updated: 2024-05-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-30
• Study Completion Date: 2028-06-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo group

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

Group Type: PLACEBO_COMPARATOR

placebo capsule

Intervention Type: OTHER

The subjects take 4 capsules a day for 84 days.

Fecal microbiota transplantation (FMT) group

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

Group Type: ACTIVE_COMPARATOR

FMT capsule

Intervention Type: OTHER

The subjects take 4 capsules a day for 84 days.

Probiotic formula group

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

Group Type: EXPERIMENTAL

Probiotic formula capsule

Intervention Type: OTHER

The subjects take 4 capsules a day for 84 days.

Interventions

Probiotic formula capsule

The subjects take 4 capsules a day for 84 days.

Intervention Type: OTHER

placebo capsule

The subjects take 4 capsules a day for 84 days.

Intervention Type: OTHER

FMT capsule

The subjects take 4 capsules a day for 84 days.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Third Military Medical University

OTHER

Sponsor Role: lead

Responsible Party

Yanling Wei

Associate director / Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yanling Wei, MD

Role: PRINCIPAL_INVESTIGATOR

Daping Hospital,Army medical university

Locations

Department of Gastroenterology, Daping Hospital, The Third Military Medical University

Chongqing, Chongqing Municipality, China

Countries

China

Central Contacts

Yanling Wei, MD

Role: CONTACT

lingzi016@126.com

15310354666

Other Identifiers

TMMU-DP-ASD-PMT-20240510

Identifier Type: -

Identifier Source: org_study_id