Actively Recruiting

Phase 1
Phase 2
Age: 7Years - 30Years
All Genders
Healthy Volunteers
ID06290258

Fecal Microbiota Transplantation for Gastrointestinal, Autistic, Emotion, and Behavior Symptoms of Patients With Autism Spectrum Disorder and Gastrointestinal Problems: a Preliminary Study

Led by Chang Gung Memorial Hospital · Updated on 2026-03-20

60

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying the effects of fecal microbiota transplantation (FMT) on children and adults aged 7 to 30 with autism spectrum disorder (ASD) who also have gastrointestinal problems. The study aims to see if FMT can improve gastrointestinal symptoms, autistic behaviors, emotional and behavioral symptoms, and sleep. It also explores the relationship between the brain-gut axis, immune system markers, and ASD. Early treatment during school age may improve development, cognition, and long-term outcomes for children with ASD. Participants will receive FMT by transplanting fecal microbiota from healthy donors into their intestines via colonoscopy. Donors are thoroughly screened to ensure safety, and patients undergo colon preparation before transplantation. After the first treatment, a second transplantation will be arranged six months later. Patients will be monitored closely for 24 hours after each procedure to ensure safety. Throughout the one-year study, participants will provide blood and stool samples before and after treatment to analyze changes in gut bacteria and immune markers. Researchers will assess gastrointestinal, autistic, emotional, and behavioral symptoms using questionnaires, along with sleep patterns and cognitive functions through actigraphy and attention tests. The study will compare results before and after FMT and with a waiting list group to evaluate the treatment's effects over time.

CONDITIONS

Brief Title

Fecal Microbiota Transplantation for Patients With Autism Spectrum Disorder.

Who Can Participate

Age: 7Years - 30Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed by a child psychiatrist with autism spectrum disorder according to DSM-5
  • Have gastrointestinal problems with a Gastrointestinal Symptoms Rating Scale score of 3 or higher
  • Age between 7 and 30 years
  • Willing to participate and sign informed consent
Not Eligible

You will not qualify if you...

  • Unable to cooperate with fecal microbiota transplantation and examinations
  • Need antibiotics within 3 months before or after the study
  • Require long-term use of proton pump inhibitors
  • Have severe physical diseases affecting treatment evaluation, such as acute gastrointestinal diseases, severe malnutrition, immunodeficiency, severe allergies, autoimmune diseases, brain injuries, or severe organic brain diseases
  • Have severe mental illness like schizophrenia or bipolar disorder
  • Used probiotics one month before the study
  • Pregnancy
  • Cannot understand the study content
  • Unwilling to participate or refuse informed consent
  • Deemed unsuitable by the principal investigator or co-investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - 1 year

Participants receive fecal microbiota transplantation through colonoscopy, with a second transplantation arranged 6 months later. They will stay in bed and be monitored for 24 hours after each transplantation to ensure safety.

2 transplantation visits with 24-hour monitoring each

Follow-up

Duration - 1 year

Participants are followed for 1 year after treatment with regular assessments of gastrointestinal, autistic, emotional, and behavioral symptoms, as well as sleep and cognitive function.

Regular follow-up visits during the year

Trial Site Locations

Total: 1 location

1

Wei-Chih Chin

Taoyuan City, Taiwan, 333423

Actively Recruiting

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Research Team

W

Wei-Chih Chin

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Frequently Asked Questions

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Published Research Related To This Trial

Gastrointestinal flora and gastrointestinal status in children with autism--comparisons to typical children and correlation with autism severity.

James B Adams, Leah J Johansen, Linda D Powell...

https://pubmed.ncbi.nlm.nih.gov/21410934

Elevated plasma cytokines in autism spectrum disorders provide evidence of immune dysfunction and are associated with impaired behavioral outcome.

Paul Ashwood, Paula Krakowiak, Irva Hertz-Picciotto...

https://pubmed.ncbi.nlm.nih.gov/20705131

Microbiota shaping - the effects of probiotics, prebiotics, and fecal microbiota transplant on cognitive functions: A systematic review.

Simone Baldi, Tiziana Mundula, Giulia Nannini...

https://pubmed.ncbi.nlm.nih.gov/34754163

Microbiota Transfer Therapy alters gut ecosystem and improves gastrointestinal and autism symptoms: an open-label study.

Dae-Wook Kang, James B Adams, Ann C Gregory...

https://pubmed.ncbi.nlm.nih.gov/28122648