NCT06419530Not yet recruiting
A Study on Probiotic Formula in Autistic Children
A Double-blind Randomized Clinical Trail Study on the Effectiveness and Safety of Probiotic Formula in Autistic Children With Gastrointestinal Symptoms
Source: ClinicalTrials.gov · Last updated 23 May 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
A Randomized controlled double-blind clinical study on the effectiveness and safety of probiotic formula in Autistic children with gastrointestinal symptoms.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 156 (estimated)
- First submitted
- 13 May 2024
- Start date
- Jun 2024
- Primary completion date
- Jun 2027
- Lead sponsor
- Third Military Medical University
- Diseases
- Autism
- NCT number
- NCT06419530
What you commit to
- Study type: Interventional
- Planned participants: 156
- From Jun 2024 to the primary completion date, Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- 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.
Who the study is looking for
- 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
Age in the registry: 3 years to 14 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Gastroenterology, Daping Hospital, The Third Military Medical University Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.