WMT pro poruchu autistického spektra (ASD)
Transplantace promyté mikrobioty (WMT) pro poruchu autistického spektra (ASD)
Autism Spectrum Disorder (ASD) is a group of serious neurodevelopmental disorders. A significant comorbidity exists between ADHD and ASD: 30%-50% of individuals with ASD exhibit ADHD symptoms, and two-thirds with ADHD show ASD traits. Intestinal microbial disturbance is common in children with ASD. A great deal of evidence shows that intestinal microbes can influence the brain to play its role through "gut-brain-microbiota axis". We intend to explore the role of Washed Microbiota Transplantation in improving symptoms of children in ASD with or without ADHD; To study the potential etiological mechanism of WMT for the neurodevelopmental disorders.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
Very few literatures reported the clinical use of microbiota or bacteria for Autism Spectrum Disorder. The most effective strategy for reconstruction of gut microbiota should be fecal microbiota transplantation (WMT). Washed microbiota transplantation (WMT) can significantly reduce FMT-related AEs by removing parasite eggs, fecal particles, and fungi through a series of automated washing procedures. This study aims to evaluate the efficacy and safety of FMT for ASD. Patients received repeated WMT with fecal from healthy donors. Microbiota analysis will also be performed on both the donor and recipient stool sample prior to transplantation, and on the recipient sample at 3 month post transplantation. This study sought to evaluate the efficacy of washed microbiota transplantation (WMT) in children with ASD and explore the role of washed bacteria transplantation in improving ASD symptoms.
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Faming Zhang, PhD
- Telefonní číslo: 086-25-58509883
- E-mail: fzhang@njmu.edu.cn
Studijní místa
-
-
Jiangsu
-
Nanjing, Jiangsu, Čína
- Nábor
- Department of Microbiota Medicine & Medical Centre for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
-
Kontakt:
- Faming Zhang, PhD
- Telefonní číslo: 086-025-58509883
- E-mail: fzhang@njmu.edu.cn
-
Nanjing, Jiangsu, Čína
- Nábor
- SIR RUN RUN hospital of Nanjing Medical University
-
Kontakt:
- Faming Zhang, PhD
- Telefonní číslo: 086-25-58509883
- E-mail: fzhang@njmu.edu.cn
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Children and adolescents with an established diagnosis of ASD or ADHD + ASD according to the Diagnostic and Statistical Manual Of Mental Disorders Fifth Edition;.
Popis
Inclusion Criteria:
- Children and adolescents with an established diagnosis of ASD or ADHD + ASD according to the Diagnostic and Statistical Manual Of Mental Disorders Fifth Edition;.
- Age 3-17 years.
- Received stable treatments for ≥1 month preceding WMT
Exclusion Criteria:
- Their guardian could not understand the questionnaires or provide informed consent.
- Diagnosed with a single-gene disorder, major brain malformations, gastrointestinal diseases (ulcerative colitis, Crohn's disease, or eosinophilic esophagitis)
- Had severe comorbidities including cardiopulmonary failure, severe liver, and kidney diseases, severe infection, tumors, etc.
- Accompanied with other life-threatening disorders required emergency treatment.
- Unable to tolerate colonoscopy or anesthesia.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: COHORT
- Časové perspektivy: PROSPECTIVE
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
|
Washed microbiota transplantation
WMT |
The prepared microbiota suspension was infused into the participates' lower gut.
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Changes in the Autism Behavior Checklist (ABC) in ASD children
Časové okno: baseline, 1 month , 3 months, 6 months post transplantation
|
ABC is a scale used for nonadaptive behaviors created to screen and indicate the probability of a diagnosis of autism. The questionnaire including 57 items related to five areas: sensorial, relational, use of body and objects, and social skills. Scale score> 67 strongly suggests the presence of autism. |
baseline, 1 month , 3 months, 6 months post transplantation
|
|
Change in Autism Treatment Evaluation Checklist (ATEC) in ASD children
Časové okno: baseline, 1 month,3 months, 6 months post transplantation
|
ASD symptoms will be assessed using the Chinese version of the Autism Treatment Evaluation Checklist (ATEC), which comprise four subscales to measure child speech/language/communication, sociability, sensory/cognitive awareness, and health/physical/behavior. The scale has 77 items that are scored by parents. The health/physical/behavior subscale is rated using a 0 (not a problem)-to-3 (serious problem) point scale, whereas the other three subscales are rated using a 0 (not true)-to-2 (very true) point scale. Higher scores represent more ASD symptoms. |
baseline, 1 month,3 months, 6 months post transplantation
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Evaluate the difference of the gut microbe composition between children with ASD and healthy children by sequencing faecal metagenome.
Časové okno: Fecal samples from ASD and healthy children were collected at baseline and 3 month, 6 months post transplantation.
|
The composition of the gut microbe was evaluated by sequencing faecal metagenome. We evaluate the differences in the structure of the flora and its metabolism between the two at the phylum, genus and species levels of the intestinal flora and control children, and to develop a model for predicting the structure of the flora. |
Fecal samples from ASD and healthy children were collected at baseline and 3 month, 6 months post transplantation.
|
|
The Sleep Disturbance Scale for Children
Časové okno: baseline, 1 month, 3 months, 6 months post transplantation
|
The Sleep Disturbance Scale for Children (SDSC) was used to assess sleep quality in children with ASD. It had 26 items, each with a score from 0-4. Higher SDSC scores indicated poorer sleep quality |
baseline, 1 month, 3 months, 6 months post transplantation
|
|
The Gastrointestinal Symptom Rating Scale
Časové okno: baseline, 1 month, 3 months, 6 months post transplantation
|
The Gastrointestinal Symptom Rating Scale (GSRS) was used to assess gastrointestinal symptoms. It was a 7-point Likert scale questionnaire with 15 items. The 15 items can be divided into 5 dimensions: abdominal pain (3 items), reflux (2 items), dyspepsia (4 items), diarrhea (3 items), and constipation (3 items). |
baseline, 1 month, 3 months, 6 months post transplantation
|
|
Clinical Global Impressions-Improvement
Časové okno: baseline, 1 months, 3 months, 6 months post transplantation
|
The Clinical Global Impressions-Improvement (CGI-I) evaluated by experienced clinician was used to assess the symptom changes relative to baseline, rated on a 7-point scale from 1 (very much improved) to 7 (very much worse) [26]. CGI-I = 1 or 2 was considered a clinical response. |
baseline, 1 months, 3 months, 6 months post transplantation
|
|
The Chinese version of Swanson, Nolan, and Pelham-IV (SNAP-IV)
Časové okno: At baseline, 1 month, 3 months and 6 months after WMT
|
It was a 26-item questionnaire that measured three of the ADHD symptoms, inattention (items 1-9), hyperactivity (items 10-18), and oppositional defiant disorder (items 19-26). The 26-item checklist was scored on a 4-point Likert scale ranging between Not At All (0) and Very Much (3). |
At baseline, 1 month, 3 months and 6 months after WMT
|
|
Conners' Parent Rating Scale-Revised (CPRS-R)
Časové okno: At baseline, 1 month, 3 months and 6 months after WMT
|
The CPRS-R was composed of 10 items derived from the Revised Conners Parent Rating Scale. It used a 4-point Likert scale (range: 0-30), with higher scores indicating more severe symptoms. |
At baseline, 1 month, 3 months and 6 months after WMT
|
Spolupracovníci a vyšetřovatelé
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Faming Zhang, PhD, The Second Hospital of Nanjing Medical University
Publikace a užitečné odkazy
Obecné publikace
- Zhang T, Lu G, Zhao Z, Liu Y, Shen Q, Li P, Chen Y, Yin H, Wang H, Marcella C, Cui B, Cheng L, Ji G, Zhang F. Washed microbiota transplantation vs. manual fecal microbiota transplantation: clinical findings, animal studies and in vitro screening. Protein Cell. 2020 Apr;11(4):251-266. doi: 10.1007/s13238-019-00684-8. Epub 2020 Jan 9.
- Nanjing consensus on methodology of washed microbiota transplantation. Chin Med J (Engl). 2020 Oct 5;133(19):2330-2332. doi: 10.1097/CM9.0000000000000954. No abstract available.
- Solmi M, Radua J, Olivola M, Croce E, Soardo L, Salazar de Pablo G, Il Shin J, Kirkbride JB, Jones P, Kim JH, Kim JY, Carvalho AF, Seeman MV, Correll CU, Fusar-Poli P. Age at onset of mental disorders worldwide: large-scale meta-analysis of 192 epidemiological studies. Mol Psychiatry. 2022 Jan;27(1):281-295. doi: 10.1038/s41380-021-01161-7. Epub 2021 Jun 2.
- Hirota T, King BH. Autism Spectrum Disorder: A Review. JAMA. 2023 Jan 10;329(2):157-168. doi: 10.1001/jama.2022.23661.
- Brugha TS, Spiers N, Bankart J, Cooper SA, McManus S, Scott FJ, Smith J, Tyrer F. Epidemiology of autism in adults across age groups and ability levels. Br J Psychiatry. 2016 Dec;209(6):498-503. doi: 10.1192/bjp.bp.115.174649. Epub 2016 Jul 7.
- Khachadourian V, Mahjani B, Sandin S, Kolevzon A, Buxbaum JD, Reichenberg A, Janecka M. Comorbidities in autism spectrum disorder and their etiologies. Transl Psychiatry. 2023 Feb 25;13(1):71. doi: 10.1038/s41398-023-02374-w.
- Liang X, Haegele JA, Tse AC, Li M, Zhang H, Zhao S, Li SX. The impact of the physical activity intervention on sleep in children and adolescents with autism spectrum disorder: A systematic review and meta-analysis. Sleep Med Rev. 2024 Apr;74:101913. doi: 10.1016/j.smrv.2024.101913. Epub 2024 Feb 23.
- Chen Y, Fang H, Li C, Wu G, Xu T, Yang X, Zhao L, Ke X, Zhang C. Gut Bacteria Shared by Children and Their Mothers Associate with Developmental Level and Social Deficits in Autism Spectrum Disorder. mSphere. 2020 Dec 2;5(6):e01044-20. doi: 10.1128/mSphere.01044-20.
- Jacob S, Veenstra-VanderWeele J, Murphy D, McCracken J, Smith J, Sanders K, Meyenberg C, Wiese T, Deol-Bhullar G, Wandel C, Ashford E, Anagnostou E. Efficacy and safety of balovaptan for socialisation and communication difficulties in autistic adults in North America and Europe: a phase 3, randomised, placebo-controlled trial. Lancet Psychiatry. 2022 Mar;9(3):199-210. doi: 10.1016/S2215-0366(21)00429-6. Epub 2022 Feb 10.
- Hung LY, Margolis KG. Autism spectrum disorders and the gastrointestinal tract: insights into mechanisms and clinical relevance. Nat Rev Gastroenterol Hepatol. 2024 Mar;21(3):142-163. doi: 10.1038/s41575-023-00857-1. Epub 2023 Dec 19.
- Liu NH, Liu HQ, Zheng JY, Zhu ML, Wu LH, Pan HF, He XX. Fresh Washed Microbiota Transplantation Alters Gut Microbiota Metabolites to Ameliorate Sleeping Disorder Symptom of Autistic Children. J Microbiol. 2023 Aug;61(8):741-753. doi: 10.1007/s12275-023-00069-x. Epub 2023 Sep 4.
- Wan Y, Zuo T, Xu Z, Zhang F, Zhan H, Chan D, Leung TF, Yeoh YK, Chan FKL, Chan R, Ng SC. Underdevelopment of the gut microbiota and bacteria species as non-invasive markers of prediction in children with autism spectrum disorder. Gut. 2022 May;71(5):910-918. doi: 10.1136/gutjnl-2020-324015. Epub 2021 Jul 26.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- WMT-ASD-2023
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .