Fecal Microbiota Transplantation for Patients With Autism Spectrum Disorder.

Launched by CHANG GUNG MEMORIAL HOSPITAL · Feb 29, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called fecal microbiota transplantation (FMT) to see if it can help improve symptoms in children and young adults with Autism Spectrum Disorder (ASD), particularly those who also have gastrointestinal (GI) problems. The researchers want to find out if FMT can change the balance of bacteria in the gut, which may help with gut issues, as well as improve behaviors and emotions related to autism. The hope is that early treatment, especially during school age, might lead to better development and cognitive outcomes.

To be eligible for the study, participants need to be between 7 and 30 years old, have a diagnosis of autism confirmed by a specialist, and also experience gastrointestinal symptoms. The trial is open to all genders, and interested participants must be willing to sign consent forms to join. Those with certain medical conditions, severe mental illnesses, or who have recently used probiotics will not be able to participate. If enrolled, participants can expect to undergo the FMT procedure and be monitored for changes in their symptoms over time.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Diagnosed by a child psychiatrist in line with DSM-5 Autism Spectrum Disorder
• • Combined with gastrointestinal problems, any Gastrointestinal Symptoms Rating Scale score≧3.
• • Age is between 7-30.
• • Participants who are willing to participate in the study and sign the informed consent.
• Exclusion Criteria:
• • Cases where clinical assessment cannot cooperate with fecal microbiota transplantation and examination.
• • Cases requiring antibiotics within 3 months before or after acceptance because of their physiological condition.
• • Cases requiring long-term use of proton pump inhibitors due to their physiological conditions.
• • Severe physical diseases, such as acute gastrointestinal diseases, severe malnutrition or underweight, immunodeficiency diseases, severe allergies or autoimmune diseases, brain injuries or severe organic brain diseases, will affect the evaluation of treatment results.
• • Severe mental illness, such as schizophrenia, bipolar disorder, etc.
• • Those who used probiotics one month before the case may affect the intestinal flora.
• • Pregnancy.
• • Cases that cannot understand the content of this research.
• • Participants who are unwilling to participate in the study or refuse to sign the informed consent.
• • Participants who are not suitable to include in this study, evaluate by PI or Co-PI.