Fecal Microbiota Transplantation for Patients With Autism Spectrum Disorder.

Phase 1

Recruiting

• Conditions: Autism Spectrum Disorder; Gastrointestinal Diseases; Healthy

• Registration Number: NCT06290258
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-1-31
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes of gastrointestinal symptoms of patients with ASD after FMT;Changes of autistic symptoms of patients with ASD after FMT

Secondary Outcome Measures

Name	Time	Method
Changes of the diversity of intestinal microbiota of patients with ASD after FMT;Changes of cytokine levels of patients with ASD after FMT;Changes of repetitive behavior symptoms of patients with ASD after FMT;Changes of autistic behavior symptoms of patients with ASD after FMT;Changes of emotion and behavior symptoms of patients with ASD after FMT;Changes of inattention and hyperactivity of patients with ASD after FMT;Changes of quality of life of patients with ASD after FMT