A Study on Probiotic Formula in Autistic Children

May 21, 2024 updated by: Yanling Wei, Third Military Medical University

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

156

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400042
        • Department of Gastroenterology, Daping Hospital, The Third Military Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo group
In this arm, 4 placebo capsules would be oral administered by participants everyday for 84 days.
Other: placebo capsule
The subjects take 4 capsules a day for 84 days.
Active Comparator: Fecal microbiota transplantation (FMT) group
In this arm, 4 FMT capsules would be oral administered by participants everyday for 84 days.
Other: FMT capsule
The subjects take 4 capsules a day for 84 days.
Experimental: Probiotic formula group
In this arm, 4 Probiotic formula capsules would be oral administered by participants everyday for 84 days.
Other: Probiotic formula capsule
The subjects take 4 capsules a day for 84 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Behavioral Rating Scale (ABC) scores of children with autism in 12th week and baseline
Time Frame: 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.
week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Childhood Autism Rating Scale(CARS) before and after treatment
Time Frame: week 0,4,8,12,24
The scale consists of 15 items, which are used by the examiners. Each item of the scale was scored according to 1-4 grades. The total score was greater than or equal to 30 points for diagnosis of autism, less than 36 points for mild-moderate autism, and for severe autism when the total score reached or greater than 36 points.
week 0,4,8,12,24
Changes in Social Responsiveness Scale(SRS) before and after treatment
Time Frame: week 0,4,8,12
The scale is composed of 65 items in 5 subscales. The content of the scale mainly involves children's daily social situations, including social perception, cognition, communication, motivation, autistic behavior and other aspects. The scale adopts a 4-point rating, and each item has four options: never, sometimes, often, and always, and is completed by parents or long-term caregivers. The higher the score, the more severe the social impairment and autistic behavior.
week 0,4,8,12
Changes in Self-Rating Anxiety Scale(SAS) before and after treatment
Time Frame: week 0,4,8,12
The scale consists of 20 items. Each item is scored on a scale of 1 to 4, and the final score is the sum of the scores for the 20 items. The final score is multiplied by 1.25 to obtain the integer part, and the standard score is obtained. An anxiety total score below 50 is considered normal; 50-60 is mild, 61-70 is moderate, and above 70 is severe anxiety.
week 0,4,8,12
Changes in Autism Diagnostic Observation Schedule(ADOS) before and after treatment
Time Frame: week 0,4,8,12
The scale is a semi-structured, standardized assessment that includes communication, social interaction, play, and restrictive and repetitive behaviors.
week 0,4,8,12
Changes in Gastrointestinal Symptom Rating Scale(GSRS) before and after treatment
Time Frame: week 0,4,8,12, 24
The scale is a tool commonly used to measure gastrointestinal symptoms. It contains multiple dimensions and items to evaluate the patient's gastrointestinal health status through scoring.
week 0,4,8,12, 24
Changes in Serum neurotransmitters (5-HT、GABA、Dopamine) of children with autism before and after treatment
Time Frame: week 0,12
There are abnormal changes in erum neurotransmitters (including 5-HT, GABA, and dopamine) in autistic children.In order to explore whether "Precision Microbiota Transplantation" can improve serum neurotransmitters (including 5-HT, GABA, and dopamine) levels.
week 0,12
Changes in gut microbiota of children with autism before and after treatment
Time Frame: week 0,12
There are abnormal changes in intestinal flora in autistic children.In order to explore whether "Precision Microbiota Transplantation" can improve the level of intestinal flora.
week 0,12
Changes in Behavioral Rating Scale (ABC) scores of children with autism before and after treatment
Time Frame: week 0,4,8, 24
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.
week 0,4,8, 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Third Military Medical University

Investigators

  • Principal Investigator: Yanling Wei, MD, Daping Hospital,Army medical university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

May 13, 2024

First Submitted That Met QC Criteria

May 13, 2024

First Posted (Actual)

May 17, 2024

Study Record Updates

Last Update Posted (Actual)

May 23, 2024

Last Update Submitted That Met QC Criteria

May 21, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TMMU-DP-ASD-PMT-20240510

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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