Fecal Microbiota Transplantation for Patients With Autism Spectrum Disorder.

NCT06290258 | Recruiting Phase 1 DMC

• 1 other identifier: 202202143A0
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Diseases; Healthy; Autism Spectrum Disorder

Keywords

Fecal Microbiota Transplantation; Autism Spectrum Disorder; gastrointestinal problems; cytokines; cognitive function

Outcome Measures

Primary Outcomes (2)

• Changes of gastrointestinal symptoms of patients with ASD after FMT

  the Gastrointestinal Symptom Rating Scale, score 15-105, higher scores mean more severe symptom

  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

  baseline and the 1-year follow-up

Secondary Outcomes (7)

• Changes of the diversity of intestinal microbiota of patients with ASD after FMT

  baseline and the 1 year follow-up

• Changes of cytokine levels of patients with ASD after FMT

  baseline and the 1 year follow-up

• Changes of repetitive behavior symptoms of patients with ASD after FMT

  baseline and the 1 year follow-up

• Changes of autistic behavior symptoms of patients with ASD after FMT

  baseline and the 1 year follow-up

• Changes of emotion and behavior symptoms of patients with ASD after FMT

  baseline and the 1 year follow-up

Other Outcomes (4)

• Changes of objective sleep of patients with ASD after FMT by actigraphy recording

  baseline and the 1 year follow-up

• Changes of subjective sleep of patients with ASD after FMT

  baseline and the 1 year follow-up

• Changes of intelligence of patients with ASD after FMT

  baseline and the 1 year follow-up

Study Arms (1)

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.

Procedure: Fecal microbiota transplantation

Interventions

Fecal microbiota transplantation PROCEDURE

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.

Fecal microbiota transplantation

Eligibility Criteria

• Age: 7 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Wei-Chih Chin

Taoyuan, 333423, Taiwan

RECRUITING

Related Publications (19)

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  PMID: 21410934 BACKGROUND

• Alharthi 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.

  PMID: 35163286 BACKGROUND

• Ashwood 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.

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• Baldi 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.

  PMID: 34754163 BACKGROUND

• Baxter 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.

  PMID: 26803556 BACKGROUND

• Borre 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.

  PMID: 24956966 BACKGROUND

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• Hsiao 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.

  PMID: 24315484 BACKGROUND

• Kang 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.

  PMID: 28122648 BACKGROUND

• Kang 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.

  PMID: 30967657 BACKGROUND

• Li 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.

  PMID: 34737978 BACKGROUND

• McElhanon 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.

  PMID: 24777214 BACKGROUND

• Molloy 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.

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• Samsam 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.

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• Souders 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.

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• Strati F, Cavalieri D, Albanese D, De Felice C, Donati C, Hayek J, Jousson O, Leoncini S, Renzi D, Calabro A, De Filippo C. New evidences on the altered gut microbiota in autism spectrum disorders. Microbiome. 2017 Feb 22;5(1):24. doi: 10.1186/s40168-017-0242-1.

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• Tan Q, Orsso CE, Deehan EC, Kung JY, Tun HM, Wine E, Madsen KL, Zwaigenbaum L, Haqq AM. Probiotics, prebiotics, synbiotics, and fecal microbiota transplantation in the treatment of behavioral symptoms of autism spectrum disorder: A systematic review. Autism Res. 2021 Sep;14(9):1820-1836. doi: 10.1002/aur.2560. Epub 2021 Jun 26.

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• Wang S, Xu M, Wang W, Cao X, Piao M, Khan S, Yan F, Cao H, Wang B. Systematic Review: Adverse Events of Fecal Microbiota Transplantation. PLoS One. 2016 Aug 16;11(8):e0161174. doi: 10.1371/journal.pone.0161174. eCollection 2016.

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• Xu M, Xu X, Li J, Li F. Association Between Gut Microbiota and Autism Spectrum Disorder: A Systematic Review and Meta-Analysis. Front Psychiatry. 2019 Jul 17;10:473. doi: 10.3389/fpsyt.2019.00473. eCollection 2019.

  PMID: 31404299 BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder; Gastrointestinal Diseases

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Wei-Chih Chin

  Chang Gung Medical Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei-Chih Chin

CONTACT

+886 3 3281200; auaug0327@cgmh.org.tw

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: March 4, 2024
• Study Start: March 6, 2024
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)