Autism Spectrum DisorderPhase 1/2NCT06290258
Fecal Microbiota Transplantation for Patients With Autism Spectrum Disorder.
A Phase 1/2 study testing Fecal microbiota transplantation in people with Autism Spectrum Disorder and Gastrointestinal Diseases, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder, Gastrointestinal Diseases, Healthy
- What is being tested?
- Fecal microbiota transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 6 Mar 2024to 31 Jul 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Wei-Chih Chin
Taoyuan City, 333423
Wei-Chih Chin, +886 3 3281200 ext. 3836, auaug0327@cgmh.org.tw
About this study
Official title: Fecal Microbiota Transplantation for Gastrointestinal, Autistic, Emotion, and Behavior Symptoms of Patients With Autism Spectrum Disorder and Gastrointestinal Problems: a Preliminary Study.
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.
Read the 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.
- Conditions
- Autism Spectrum Disorder, Gastrointestinal Diseases, Healthy
- Being tested
- Fecal microbiota transplantation
- Keywords
- Fecal Microbiota Transplantation, Autism Spectrum Disorder, gastrointestinal problems, cytokines, cognitive function
- Medical subject headings
- Autism Spectrum Disorder, Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal microbiota transplantationProcedure or surgery
Fecal microbiota transplantation has been applied to patients with autism spectrum disorder in recent years. Fecal microbiota of healthy donors can be transplanted to patients through colonoscopy. Before donation, donors were comprehensively screened to rule out gastrointestinal symptoms and infections. Patients will receive colon preparation before transplantation. After the intervention, patients will have to stay in bed and be monitored for 24 hours to assure safety.
| Study group | Role | What they receive |
|---|---|---|
| Fecal microbiota transplantation | Experimental | Children with autism spectrum disorder will receive fecal microbiota transplantation after evaluation. After the first intervention, the second transplantation will be arranged 6 months later. Receives: Procedure: Fecal microbiota transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of gastrointestinal symptoms of patients with ASD after FMT
the Gastrointestinal Symptom Rating Scale, score 15-105, higher scores mean more severe symptom
Measured: baseline and the 1-year follow-up
Changes of autistic symptoms of patients with ASD after FMT
the Social Responsiveness Scale, score 0-195, higher scores mean more severe symptom
Measured: baseline and the 1-year follow-up
Secondary outcomes (7)
Changes of the diversity of intestinal microbiota of patients with ASD after FMT
microbial DNA was extracted from feces by Reagent Kit v3, and the diversity indices were calculated by using the vegan package in R version 3.2.3. higher indices suggest higher microbial diversity
Measured: baseline and the 1 year follow-up
Changes of cytokine levels of patients with ASD after FMT
cytokine levels
Measured: baseline and the 1 year follow-up
Changes of repetitive behavior symptoms of patients with ASD after FMT
the Repetitive Behavior Scale-Revised data, higher score suggest more repetitive behavior
Measured: baseline and the 1 year follow-up
Changes of autistic behavior symptoms of patients with ASD after FMT
the Aberrant Behavior Checklist data, higher score suggest more autistic behavior
Measured: baseline and the 1 year follow-up
Changes of emotion and behavior symptoms of patients with ASD after FMT
the Child Behavior Checklist Adaptive Behavior Assessment System® - Second Edition data, higher score suggest more emotion and behavior symptoms
Measured: baseline and the 1 year follow-up
Changes of inattention and hyperactivity of patients with ASD after FMT
the Swanson, Nolan and Pelham IV Scale data, higher score suggest worse attention and more hyperactivity
Measured: baseline and the 1 year follow-up
Changes of quality of life of patients with ASD after FMT
the 36-Item Short Form Health Survey data, higher score suggest better quality of life
Measured: baseline and the 1 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start6 Mar 2024
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei-Chih Chin, Principal investigator, Chang Gung Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06290258
- Sponsor's protocol ID
- 202202143A0
- Status last verified
- Mar 2026
- First submitted
- 31 Jan 2024
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Adams JB, Johansen LJ, Powell LD, Quig D, Rubin RA. Gastrointestinal flora and gastrointestinal status in children with autism--comparisons to typical children and correlation with autism severity. BMC Gastroenterol. 2011 Mar 16;11:22. doi: 10.1186/1471-230X-11-22.
PubMed 21410934Alharthi A, Alhazmi S, Alburae N, Bahieldin A. The Human Gut Microbiome as a Potential Factor in Autism Spectrum Disorder. Int J Mol Sci. 2022 Jan 25;23(3):1363. doi: 10.3390/ijms23031363.
PubMed 35163286Ashwood P, Krakowiak P, Hertz-Picciotto I, Hansen R, Pessah I, Van de Water J. Elevated plasma cytokines in autism spectrum disorders provide evidence of immune dysfunction and are associated with impaired behavioral outcome. Brain Behav Immun. 2011 Jan;25(1):40-5. doi: 10.1016/j.bbi.2010.08.003. Epub 2010 Aug 10.
PubMed 20705131Baldi S, Mundula T, Nannini G, Amedei A. Microbiota shaping - the effects of probiotics, prebiotics, and fecal microbiota transplant on cognitive functions: A systematic review. World J Gastroenterol. 2021 Oct 21;27(39):6715-6732. doi: 10.3748/wjg.v27.i39.6715.
PubMed 34754163Baxter M, Colville A. Adverse events in faecal microbiota transplant: a review of the literature. J Hosp Infect. 2016 Feb;92(2):117-27. doi: 10.1016/j.jhin.2015.10.024. Epub 2015 Dec 15.
PubMed 26803556Borre YE, O'Keeffe GW, Clarke G, Stanton C, Dinan TG, Cryan JF. Microbiota and neurodevelopmental windows: implications for brain disorders. Trends Mol Med. 2014 Sep;20(9):509-18. doi: 10.1016/j.molmed.2014.05.002. Epub 2014 Jun 20.
PubMed 24956966Croonenberghs J, Bosmans E, Deboutte D, Kenis G, Maes M. Activation of the inflammatory response system in autism. Neuropsychobiology. 2002;45(1):1-6. doi: 10.1159/000048665.
PubMed 11803234Hsiao EY, McBride SW, Hsien S, Sharon G, Hyde ER, McCue T, Codelli JA, Chow J, Reisman SE, Petrosino JF, Patterson PH, Mazmanian SK. Microbiota modulate behavioral and physiological abnormalities associated with neurodevelopmental disorders. Cell. 2013 Dec 19;155(7):1451-63. doi: 10.1016/j.cell.2013.11.024. Epub 2013 Dec 5.
PubMed 24315484Kang DW, Adams JB, Gregory AC, Borody T, Chittick L, Fasano A, Khoruts A, Geis E, Maldonado J, McDonough-Means S, Pollard EL, Roux S, Sadowsky MJ, Lipson KS, Sullivan MB, Caporaso JG, Krajmalnik-Brown R. Microbiota Transfer Therapy alters gut ecosystem and improves gastrointestinal and autism symptoms: an open-label study. Microbiome. 2017 Jan 23;5(1):10. doi: 10.1186/s40168-016-0225-7.
PubMed 28122648Kang DW, Adams JB, Coleman DM, Pollard EL, Maldonado J, McDonough-Means S, Caporaso JG, Krajmalnik-Brown R. Long-term benefit of Microbiota Transfer Therapy on autism symptoms and gut microbiota. Sci Rep. 2019 Apr 9;9(1):5821. doi: 10.1038/s41598-019-42183-0.
PubMed 30967657Li N, Chen H, Cheng Y, Xu F, Ruan G, Ying S, Tang W, Chen L, Chen M, Lv L, Ping Y, Chen D, Wei Y. Fecal Microbiota Transplantation Relieves Gastrointestinal and Autism Symptoms by Improving the Gut Microbiota in an Open-Label Study. Front Cell Infect Microbiol. 2021 Oct 19;11:759435. doi: 10.3389/fcimb.2021.759435. eCollection 2021.
PubMed 34737978McElhanon BO, McCracken C, Karpen S, Sharp WG. Gastrointestinal symptoms in autism spectrum disorder: a meta-analysis. Pediatrics. 2014 May;133(5):872-83. doi: 10.1542/peds.2013-3995.
PubMed 24777214Molloy CA, Morrow AL, Meinzen-Derr J, Schleifer K, Dienger K, Manning-Courtney P, Altaye M, Wills-Karp M. Elevated cytokine levels in children with autism spectrum disorder. J Neuroimmunol. 2006 Mar;172(1-2):198-205. doi: 10.1016/j.jneuroim.2005.11.007. Epub 2005 Dec 19.
PubMed 16360218Samsam M, Ahangari R, Naser SA. Pathophysiology of autism spectrum disorders: revisiting gastrointestinal involvement and immune imbalance. World J Gastroenterol. 2014 Aug 7;20(29):9942-51. doi: 10.3748/wjg.v20.i29.9942.
PubMed 25110424Souders MC, Mason TB, Valladares O, Bucan M, Levy SE, Mandell DS, Weaver TE, Pinto-Martin J. Sleep behaviors and sleep quality in children with autism spectrum disorders. Sleep. 2009 Dec;32(12):1566-78. doi: 10.1093/sleep/32.12.1566.
PubMed 20041592
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbiota Transplantation for Gastrointestinal, Autistic, Emotion, and Behavior Symptoms of Patients With Autism Spectrum Disorder and Gastrointestinal Problems: a Preliminary Study.
- ClinicalTrials.gov ID
- NCT06290258
- Acronym / sponsor ID
- 202202143A0
- Conditions
- Autism Spectrum Disorder, Gastrointestinal Diseases, Healthy
- Keywords
- Fecal Microbiota Transplantation, Autism Spectrum Disorder, gastrointestinal problems, cytokines, cognitive function
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 6 Mar 2024 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 4 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fecal microbiota transplantation | Experimental | Procedure: Fecal microbiota transplantationChildren with autism spectrum disorder will receive fecal microbiota transplantation after evaluation. After the first intervention, the second transplantation will be arranged 6 months later. |
Who may qualify
- Ages
- 7 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fecal microbiota transplantationFecal microbiota transplantation has been applied to patients with autism spectrum disorder in recent years. Fecal microbiota of healthy donors can be transplanted to patients through colonoscopy. Before donation, donors were comprehensively screened to rule out gastrointestinal symptoms and infections. Patients will receive colon preparation before transplantation. After the intervention, patients will have to stay in bed and be monitored for 24 hours to assure safety. | Procedure or surgery | Fecal microbiota transplantation |
Primary outcome
Changes of gastrointestinal symptoms of patients with ASD after FMT
Time frame: baseline and the 1-year follow-up
the Gastrointestinal Symptom Rating Scale, score 15-105, higher scores mean more severe symptom
Changes of autistic symptoms of patients with ASD after FMT
Time frame: baseline and the 1-year follow-up
the Social Responsiveness Scale, score 0-195, higher scores mean more severe symptom
7 secondary outcomes
Changes of the diversity of intestinal microbiota of patients with ASD after FMT
Time frame: baseline and the 1 year follow-up
Changes of cytokine levels of patients with ASD after FMT
Time frame: baseline and the 1 year follow-up
Changes of repetitive behavior symptoms of patients with ASD after FMT
Time frame: baseline and the 1 year follow-up
Changes of autistic behavior symptoms of patients with ASD after FMT
Time frame: baseline and the 1 year follow-up
Changes of emotion and behavior symptoms of patients with ASD after FMT
Time frame: baseline and the 1 year follow-up
Changes of inattention and hyperactivity of patients with ASD after FMT
Time frame: baseline and the 1 year follow-up
Changes of quality of life of patients with ASD after FMT
Time frame: baseline and the 1 year follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Background: PubMed 21410934Adams JB, Johansen LJ, Powell LD, Quig D, Rubin RA. Gastrointestinal flora and gastrointestinal status in children with autism--comparisons to typical children and correlation with autism severity. BMC Gastroenterol. 2011 Mar 16;11:22. doi: 10.1186/1471-230X-11-22.
- Background: PubMed 35163286Alharthi A, Alhazmi S, Alburae N, Bahieldin A. The Human Gut Microbiome as a Potential Factor in Autism Spectrum Disorder. Int J Mol Sci. 2022 Jan 25;23(3):1363. doi: 10.3390/ijms23031363.
- Background: PubMed 20705131Ashwood P, Krakowiak P, Hertz-Picciotto I, Hansen R, Pessah I, Van de Water J. Elevated plasma cytokines in autism spectrum disorders provide evidence of immune dysfunction and are associated with impaired behavioral outcome. Brain Behav Immun. 2011 Jan;25(1):40-5. doi: 10.1016/j.bbi.2010.08.003. Epub 2010 Aug 10.
- Background: PubMed 34754163Baldi S, Mundula T, Nannini G, Amedei A. Microbiota shaping - the effects of probiotics, prebiotics, and fecal microbiota transplant on cognitive functions: A systematic review. World J Gastroenterol. 2021 Oct 21;27(39):6715-6732. doi: 10.3748/wjg.v27.i39.6715.
- Background: PubMed 26803556Baxter M, Colville A. Adverse events in faecal microbiota transplant: a review of the literature. J Hosp Infect. 2016 Feb;92(2):117-27. doi: 10.1016/j.jhin.2015.10.024. Epub 2015 Dec 15.
- Background: PubMed 24956966Borre YE, O'Keeffe GW, Clarke G, Stanton C, Dinan TG, Cryan JF. Microbiota and neurodevelopmental windows: implications for brain disorders. Trends Mol Med. 2014 Sep;20(9):509-18. doi: 10.1016/j.molmed.2014.05.002. Epub 2014 Jun 20.
- Background: PubMed 11803234Croonenberghs J, Bosmans E, Deboutte D, Kenis G, Maes M. Activation of the inflammatory response system in autism. Neuropsychobiology. 2002;45(1):1-6. doi: 10.1159/000048665.
- Background: PubMed 24315484Hsiao EY, McBride SW, Hsien S, Sharon G, Hyde ER, McCue T, Codelli JA, Chow J, Reisman SE, Petrosino JF, Patterson PH, Mazmanian SK. Microbiota modulate behavioral and physiological abnormalities associated with neurodevelopmental disorders. Cell. 2013 Dec 19;155(7):1451-63. doi: 10.1016/j.cell.2013.11.024. Epub 2013 Dec 5.
- Background: PubMed 28122648Kang DW, Adams JB, Gregory AC, Borody T, Chittick L, Fasano A, Khoruts A, Geis E, Maldonado J, McDonough-Means S, Pollard EL, Roux S, Sadowsky MJ, Lipson KS, Sullivan MB, Caporaso JG, Krajmalnik-Brown R. Microbiota Transfer Therapy alters gut ecosystem and improves gastrointestinal and autism symptoms: an open-label study. Microbiome. 2017 Jan 23;5(1):10. doi: 10.1186/s40168-016-0225-7.
- Background: PubMed 30967657Kang DW, Adams JB, Coleman DM, Pollard EL, Maldonado J, McDonough-Means S, Caporaso JG, Krajmalnik-Brown R. Long-term benefit of Microbiota Transfer Therapy on autism symptoms and gut microbiota. Sci Rep. 2019 Apr 9;9(1):5821. doi: 10.1038/s41598-019-42183-0.
- Background: PubMed 34737978Li N, Chen H, Cheng Y, Xu F, Ruan G, Ying S, Tang W, Chen L, Chen M, Lv L, Ping Y, Chen D, Wei Y. Fecal Microbiota Transplantation Relieves Gastrointestinal and Autism Symptoms by Improving the Gut Microbiota in an Open-Label Study. Front Cell Infect Microbiol. 2021 Oct 19;11:759435. doi: 10.3389/fcimb.2021.759435. eCollection 2021.
- Background: PubMed 24777214McElhanon BO, McCracken C, Karpen S, Sharp WG. Gastrointestinal symptoms in autism spectrum disorder: a meta-analysis. Pediatrics. 2014 May;133(5):872-83. doi: 10.1542/peds.2013-3995.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wei-Chih Chin principal investigator
Chang Gung Medical Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Fecal microbiota transplantation in people with Autism Spectrum Disorder and Gastrointestinal Diseases, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wei-Chih Chin (+886 3 3281200 ext. 3836, auaug0327@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of gastrointestinal symptoms of patients with ASD after FMT (time frame: baseline and the 1-year follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06290258, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.