A Study on Probiotic Formula in Autistic Children

NCT06419530 · tracked via the Priya Life Science China tracker

Sponsor

Third Military Medical University

Phase

Not applicable

Started

2024-06

Last updated

2024-05-23

Condition(s) studied

Autism Spectrum Disorder

Investigational drug(s) / intervention(s)

Probiotic formula capsuleplacebo capsuleFMT capsule

Probiotic formula capsule: The subjects take 4 capsules a day for 84 days.

placebo capsule: The subjects take 4 capsules a day for 84 days.

FMT capsule: The subjects take 4 capsules a day for 84 days.

Study summary

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

Eligibility

Sex

ALL

Min age

3 Years

Max age

14 Years

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.

Primary outcome measure(s)

Changes in Behavioral Rating Scale (ABC) scores of children with autism in 12th week and baseline — week 12
This scale lists 57 items of abnormal performance in sensation, behavior, emotion and language, and makes the judgment of "yes" and "no" in each item. (the informant refers to the parents of the child or those who have lived with the child for more than two weeks.) when scoring, make "yes" and "no" to each item, "yes" is the symbol"√", and "no" is not marked. The total score of "yes" items is 158, and the screening limit is 53-67 points. 53 points were used as the diagnostic threshold of autism, and the diagnosis score was 67 points.

Trial sites (1)

Facility	City	Region	Status
Department of Gastroenterology, Daping Hospital, The Third Military Medical University	Chongqing	Chongqing Municipality

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06419530 on ClinicalTrials.gov ↗ ← All trials in China