Autism Spectrum Disorder Trial, Recruiting NCT07381374 Sponsor: Shenzhen Children's Hospital Condition: Autism Spectrum Disorder
Back to Autism Spectrum Disorder

Autism Spectrum Disorder Trial, Recruiting

NCT07381374
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Children between 3 and 16 years of age
  • Children who have been diagnosed with Autism Spectrum Disorder (ASD) under standard diagnostic guidelines, with a rating scale score indicating moderate-to-severe autism
  • Children whose legal guardians fully understand the trial's consent information and are willing to provide written agreement to participate
  • Children whose families are able to attend follow-up visits and allow required tests and sample collection
  • Children who have not taken any probiotic supplements in the 3 months before joining the trial

Who may not be able to join:

  • Children who have used probiotics or prebiotics (gut health supplements) in the 3 months before enrolling
  • Children who have taken antibiotics in the month before enrolling
  • Children who currently have a fever (underarm temperature of 37.5°C or higher)
  • Children who depend on a feeding tube for nutrition
  • Children with serious gut or digestive conditions that need urgent medical treatment, such as intestinal blockage, perforation, bleeding, ulcerative colitis, Crohn's disease, coeliac disease, or eosinophilic oesophagitis
  • Children diagnosed with severe malnutrition, significantly low body weight for their age, or serious immune system disorders
  • Children with a history of severe allergic reactions, such as anaphylaxis
  • Children whose autism is linked to a specific known genetic condition, such as Fragile X syndrome or Rett syndrome
  • Children who also have another diagnosed psychiatric or developmental condition, such as depression, ADHD, intellectual disability, speech or language disorders, selective mutism, reactive attachment disorder, or childhood schizophrenia

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 16 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Phone: 08618938690736

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Shenzhen Children's Hospital
Registry
ClinicalTrials.gov
Start date
21 March 2026
Est. completion
31 December 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Change in Total Score on the Childhood Autism Rating Scale (CARS)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 16 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov