Tests a probiotic capsule in autistic children with stomach symptoms
Tests a probiotic capsule in autistic children with gut symptoms.
Key facts
- Who runs it
- Third Military Medical University
- Where
- Chongqing, ChinaSee the site
- Trial code
- Registry title
- A Study on Probiotic Formula in Autistic Children
- Status
- Not yet recruiting
- People taking part
- 156 people, planned
- Started
- Jun 2024
- Expected to end
- Jun 2028
- Type of study
- Interventional, 3 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Probiotic formula capsule
- placebo capsule
- FMT capsule
- Record updated
- 23 May 2024
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children and teenagers aged 3-11 with autism who have had stomach or bowel problems for at least 14 days.
- Age
- 3-11 years old (inclusion criteria). The registry header lists 3 Years to 14 Years.
- Sex
- All sexes can join.
- Disease stage
- A clinical diagnosis of autism spectrum disorder (ASD) by DSM-V, with gut symptoms for at least 14 days: diarrhea, constipation, abdominal pain, bloating and/or food allergies/intolerances.
- Earlier treatment
- Cannot have used antibiotics or probiotics within 1 month. Cannot be taking medications related to mental disorders or depression.
Main reasons for not taking part
- Antibiotics or probiotics used within 1 month
- Serious gut problems needing immediate treatment (such as life-threatening intestinal obstruction, perforation or bleeding)
- Medications related to mental disorders or depression
- Relying on tube feeding
- Cannot swallow capsules
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 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 take part
- Serious gastrointestinal problems that require immediate treatment (such as life-threatening intestinal obstruction, intestinal perforation, intestinal bleeding
- Medications related to mental disorders or depression
- History of severe allergies
- Antibiotics or probiotics used within 1 mont
- Relying on tube feeding
- Swallowing dysfunction that unable to take capsules
- Paticipation in other clinical studies within 4 weeks
- Poor compliance and have difficulty in completing follow-up
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 3 and 14 years old?
Where in China
- Department of Gastroenterology, Daping Hospital, The Third Military Medical UniversityChongqing, ChinaContact: Yanling Wei, MDNo longer taking part
About the trial
What the trial wants to find out
A Randomized controlled double-blind clinical study on the effectiveness and safety of probiotic formula in Autistic children with gastrointestinal symptoms.
The 3 groups in the trial
- Placebo groupPlacebo, for comparison
In this arm, 4 placebo capsules would be oral administered by participants everyday for 84 days.
Treatment: placebo capsule
- Fecal microbiota transplantation (FMT) groupExisting treatment, for comparison
In this arm, 4 FMT capsules would be oral administered by participants everyday for 84 days.
Treatment: FMT capsule
- Probiotic formula groupTreatment being tested
In this arm, 4 Probiotic formula capsules would be oral administered by participants everyday for 84 days.
Treatment: Probiotic formula capsule
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Double-blind Randomized Clinical Trail Study on the Effectiveness and Safety of Probiotic Formula in Autistic Children With Gastrointestinal Symptoms
- Plain-language title
- Tests a probiotic capsule in autistic children with stomach symptomsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06419530, who can take part
- Record updated
- 23 May 2024