Autism Spectrum DisorderNCT06419530
A Study on Probiotic Formula in Autistic Children
A study testing Probiotic formula capsule and FMT capsule in people with Autism Spectrum Disorder, run by Third Military Medical University at 1 site in China.
Trial summary
A Randomized controlled double-blind clinical study on the effectiveness and safety of probiotic formula in Autistic children with gastrointestinal symptoms. Read more about this study
- Who is it for?
- Ages 3 to 14 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Probiotic formula capsule and FMT capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 156 participants
- Where
- 1 siteChina
- Study dates
- Jun 2024to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Department of Gastroenterology, Daping Hospital, The Third Military Medical University
Chongqing, Chongqing Municipality, 400042
About this study
Official title: 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.
Read the 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
- Being tested
- Probiotic formula capsule, placebo capsule, FMT capsule
- Keywords
- Autism Spectrum Disorder, Gut microbiota
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic formula capsuleOther
The subjects take 4 capsules a day for 84 days.
placebo capsuleOther
The subjects take 4 capsules a day for 84 days.
FMT capsuleOther
The subjects take 4 capsules a day for 84 days.
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Placebo comparator | In this arm, 4 placebo capsules would be oral administered by participants everyday for 84 days. Receives: Other: placebo capsule |
| Fecal microbiota transplantation (FMT) group | Active comparator | In this arm, 4 FMT capsules would be oral administered by participants everyday for 84 days. Receives: Other: FMT capsule |
| Probiotic formula group | Experimental | In this arm, 4 Probiotic formula capsules would be oral administered by participants everyday for 84 days. Receives: Other: Probiotic formula capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Behavioral Rating Scale (ABC) scores of children with autism in 12th week and baseline
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.
Measured: week 12
Secondary outcomes (8)
Changes in Childhood Autism Rating Scale(CARS) before and after treatment
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.
Measured: week 0,4,8,12,24
Changes in Social Responsiveness Scale(SRS) before and after treatment
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.
Measured: week 0,4,8,12
Changes in Self-Rating Anxiety Scale(SAS) before and after treatment
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.
Measured: week 0,4,8,12
Changes in Autism Diagnostic Observation Schedule(ADOS) before and after treatment
The scale is a semi-structured, standardized assessment that includes communication, social interaction, play, and restrictive and repetitive behaviors.
Measured: week 0,4,8,12
Changes in Gastrointestinal Symptom Rating Scale(GSRS) before and after treatment
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.
Measured: week 0,4,8,12, 24
Changes in Serum neurotransmitters (5-HT、GABA、Dopamine) of children with autism before and after treatment
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.
Measured: week 0,12
Changes in gut microbiota of children with autism before and after treatment
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.
Measured: week 0,12
Changes in Behavioral Rating Scale (ABC) scores of children with autism before and after treatment
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.
Measured: week 0,4,8, 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study startJun 2024 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanling Wei, Third Military Medical University
- Investigators
- Yanling Wei, MD, Principal investigator, Daping Hospital, Army Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06419530
- Sponsor's protocol ID
- TMMU-DP-ASD-PMT-20240510
- Status last verified
- May 2024
- First submitted
- 13 May 2024
- Last updated
- 23 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind Randomized Clinical Trail Study on the Effectiveness and Safety of Probiotic Formula in Autistic Children With Gastrointestinal Symptoms
- ClinicalTrials.gov ID
- NCT06419530
- Acronym / sponsor ID
- TMMU-DP-ASD-PMT-20240510
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism Spectrum Disorder, Gut microbiota
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Third Military Medical UniversityUniversity, hospital or other
- Study start
- Jun 2024 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 17 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Placebo comparator | Other: placebo capsuleIn this arm, 4 placebo capsules would be oral administered by participants everyday for 84 days. |
| Fecal microbiota transplantation (FMT) group | Active comparator | Other: FMT capsuleIn this arm, 4 FMT capsules would be oral administered by participants everyday for 84 days. |
| Probiotic formula group | Experimental | Other: Probiotic formula capsuleIn this arm, 4 Probiotic formula capsules would be oral administered by participants everyday for 84 days. |
Who may qualify
- Ages
- 3 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic formula capsuleThe subjects take 4 capsules a day for 84 days. | Other | Probiotic formula group |
| placebo capsuleThe subjects take 4 capsules a day for 84 days. | Other | Placebo group |
| FMT capsuleThe subjects take 4 capsules a day for 84 days. | Other | Fecal microbiota transplantation (FMT) group |
Primary outcome
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.
8 secondary outcomes
Changes in Childhood Autism Rating Scale(CARS) before and after treatment
Time frame: week 0,4,8,12,24
Changes in Social Responsiveness Scale(SRS) before and after treatment
Time frame: week 0,4,8,12
Changes in Self-Rating Anxiety Scale(SAS) before and after treatment
Time frame: week 0,4,8,12
Changes in Autism Diagnostic Observation Schedule(ADOS) before and after treatment
Time frame: week 0,4,8,12
Changes in Gastrointestinal Symptom Rating Scale(GSRS) before and after treatment
Time frame: 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
Changes in gut microbiota of children with autism before and after treatment
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yanling Wei, MD principal investigator
Daping Hospital, Army Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic formula capsule and FMT capsule in people with Autism Spectrum Disorder, run by Third Military Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yanling Wei, MD (15310354666, lingzi016@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Behavioral Rating Scale (ABC) scores of children with autism in 12th week and baseline (time frame: week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2024; AzTrials last refreshed its copy on 1 Nov 2026.