Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06290258
Status:
RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-01-31
Brief Title:
Fecal Microbiota Transplantation for Patients With Autism Spectrum Disorder
Sponsor:
Chang Gung Memorial Hospital
Organization:
Chang Gung Memorial Hospital
Study Overview
Official Title:
Fecal Microbiota Transplantation for Gastrointestinal Autistic Emotion and Behavior Symptoms of Patients With Autism Spectrum Disorder and Gastrointestinal Problems a Preliminary Study
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to evaluate the efficacy of fecal microbiota transplantation on the gastrointestinal symptoms autistic symptoms and emotional behavior symptoms of patients with autism spectrum disorder and investigate the relations between the brain-gut axis cytokines and autism spectrum disorder Fecal microbiota transplantation have the potentials to improve intestinal microbiota composition regulate immunity and then improve gastrointestinal symptoms autistic symptoms emotional behavior symptoms and sleep of children with autism spectrum disorder Early intervention at school-age may even benefit development improve cognition and prognosis
Detailed Description:
Autism spectrum disorder ASD is an early neuropsychiatric developmental disorder About 7-90 of patients with ASD have gastrointestinal problems which can relate to abnormal intestinal microbiota The brain-gut axis can play a key role in the development of brain and the interaction between microbiota and central nerve system can relate to the pathophysiology of ASD Fecal Microbiota Transplantation FMT has just been used in the treatment of ASD in recent years It has the potential to improve gastrointestinal autistic emotion and behavior symptoms of patients with ASD Studies of its efficacy are still scarce and no study has been conducted in Taiwan
The purpose of this study is to treat patients with ASD by the fecal microbiota transplantation and evaluate its efficacy in gastrointestinal autistic emotion and behavior symptoms It aims to prove the correlations between the brain-gut axis intestinal microbiota cytokines and ASD FMT may improve and change the composition and diversity of intestinal microbiota of patients with ASD and modulate their immune reactions and subsequently improve gastrointestinal autistic emotion and behavior symptoms as well as sleep Early intervention by FMT in children with ASD may improve their cognition and hence result in better prognosis
Study design The investigators will recruit 45 patients with ASD and gastrointestinal problems aged 6-30 years who are willing to receive FMT and 1-year regular follow-up The investigators will collect demographic data blood and stool samples before and after the intervention and analyze changes of intestinal microbiota and cytokines The investigators will use subjective questionnaires to evaluate gastrointestinal autistic emotion and behavior symptoms and objective measurements including actigraphy intelligence and attention tests to evaluate changes in sleep and cognitive functions The investigators will analyze the correlations between collected variables and compare the ASD group with the healthy control group at baseline to evaluate group differences The investigators will evaluate the differences of the intervention group before and after FMT and also compare the intervention group with the waiting list group to evaluate the efficacy of FMT Variables will be presented by mean and percentage The investigators will use independent sample t-test or Chi-squared test for group comparison The efficacy of FMT will be analyzed by dependent sample t-test or Wilcoxon signed-rank test and the investigators will use Pearson correlation coefficient to analyze the correlations between variables
The purpose of this study is to treat patients with ASD by the fecal microbiota transplantation and evaluate its efficacy in gastrointestinal autistic emotion and behavior symptoms It aims to prove the correlations between the brain-gut axis intestinal microbiota cytokines and ASD FMT may improve and change the composition and diversity of intestinal microbiota of patients with ASD and modulate their immune reactions and subsequently improve gastrointestinal autistic emotion and behavior symptoms as well as sleep Early intervention by FMT in children with ASD may improve their cognition and hence result in better prognosis
Study design The investigators will recruit 45 patients with ASD and gastrointestinal problems aged 6-30 years who are willing to receive FMT and 1-year regular follow-up The investigators will collect demographic data blood and stool samples before and after the intervention and analyze changes of intestinal microbiota and cytokines The investigators will use subjective questionnaires to evaluate gastrointestinal autistic emotion and behavior symptoms and objective measurements including actigraphy intelligence and attention tests to evaluate changes in sleep and cognitive functions The investigators will analyze the correlations between collected variables and compare the ASD group with the healthy control group at baseline to evaluate group differences The investigators will evaluate the differences of the intervention group before and after FMT and also compare the intervention group with the waiting list group to evaluate the efficacy of FMT Variables will be presented by mean and percentage The investigators will use independent sample t-test or Chi-squared test for group comparison The efficacy of FMT will be analyzed by dependent sample t-test or Wilcoxon signed-rank test and the investigators will use Pearson correlation coefficient to analyze the correlations between variables
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None