Protocol for the Gut Bugs in Autism Trial: a double-blind randomised placebo-controlled trial of faecal microbiome transfer for the treatment of gastrointestinal symptoms in autistic adolescents and adults.

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dc.citation.issue2
dc.citation.volume14
dc.contributor.authorTweedie-Cullen RY
dc.contributor.authorLeong K
dc.contributor.authorWilson BC
dc.contributor.authorDerraik JGB
dc.contributor.authorAlbert BB
dc.contributor.authorMonk R
dc.contributor.authorVatanen T
dc.contributor.authorCreagh C
dc.contributor.authorDepczynski M
dc.contributor.authorEdwards T
dc.contributor.authorBeck K
dc.contributor.authorThabrew H
dc.contributor.authorO'Sullivan JM
dc.contributor.authorCutfield WS
dc.coverage.spatialEngland
dc.date.accessioned2024-05-09T02:25:07Z
dc.date.available2024-05-09T02:25:07Z
dc.date.issued2024-02-06
dc.description.abstractINTRODUCTION: Autism (formally autism spectrum disorder) encompasses a group of complex neurodevelopmental conditions, characterised by differences in communication and social interactions. Co-occurring chronic gastrointestinal symptoms are common among autistic individuals and can adversely affect their quality of life. This study aims to evaluate the efficacy of oral encapsulated faecal microbiome transfer (FMT) in improving gastrointestinal symptoms and well-being among autistic adolescents and adults. METHODS AND ANALYSIS: This double-blind, randomised, placebo-controlled trial will recruit 100 autistic adolescents and adults aged 16-45 years, who have mild to severe gastrointestinal symptoms (Gastrointestinal Symptoms Rating Scale (GSRS) score ≥2.0). We will also recruit eight healthy donors aged 18-32 years, who will undergo extensive clinical screening. Recipients will be randomised 1:1 to receive FMT or placebo, stratified by biological sex. Capsules will be administered over two consecutive days following an overnight bowel cleanse with follow-up assessments at 6, 12 and 26 weeks post-treatment. The primary outcome is GSRS score at 6 weeks. Other assessments include anthropometry, body composition, hair cortisol concentration, gut microbiome profile, urine/plasma gut-derived metabolites, plasma markers of gut inflammation/permeability and questionnaires on general well-being, sleep quality, physical activity, food diversity and treatment tolerability. Adverse events will be recorded and reviewed by an independent data monitoring committee. ETHICS AND DISSEMINATION: Ethics approval for the study was granted by the Central Health and Disability Ethics Committee on 24 August 2021 (reference number: 21/CEN/211). Results will be published in peer-reviewed journals and presented to both scientific and consumer group audiences. TRIAL REGISTRATION NUMBER: ACTRN12622000015741.
dc.description.confidentialfalse
dc.format.paginatione074625-
dc.identifier.author-urlhttps://www.ncbi.nlm.nih.gov/pubmed/38320845
dc.identifier.citationTweedie-Cullen RY, Leong K, Wilson BC, Derraik JGB, Albert BB, Monk R, Vatanen T, Creagh C, Depczynski M, Edwards T, Beck K, Thabrew H, O'Sullivan JM, Cutfield WS. (2024). Protocol for the Gut Bugs in Autism Trial: a double-blind randomised placebo-controlled trial of faecal microbiome transfer for the treatment of gastrointestinal symptoms in autistic adolescents and adults.. BMJ Open. 14. 2. (pp. e074625-).
dc.identifier.doi10.1136/bmjopen-2023-074625
dc.identifier.eissn2044-6055
dc.identifier.elements-typejournal-article
dc.identifier.issn2044-6055
dc.identifier.number074625
dc.identifier.piibmjopen-2023-074625
dc.identifier.urihttps://mro.massey.ac.nz/handle/10179/69535
dc.languageeng
dc.publisherBMJ Publishing Group
dc.publisher.urihttps://bmjopen.bmj.com/content/14/2/e074625
dc.relation.isPartOfBMJ Open
dc.rights(c) 2024 The Author/s
dc.rightsCC BY-NC 4.0
dc.rights.urihttps://creativecommons.org/licenses/by-nc/4.0/
dc.subjectGASTROENTEROLOGY
dc.subjectGENERAL MEDICINE (see Internal Medicine)
dc.subjectPSYCHIATRY
dc.subjectAdult
dc.subjectHumans
dc.subjectAdolescent
dc.subjectAutistic Disorder
dc.subjectAutism Spectrum Disorder
dc.subjectFecal Microbiota Transplantation
dc.subjectQuality of Life
dc.subjectGastrointestinal Diseases
dc.subjectDouble-Blind Method
dc.subjectGastrointestinal Microbiome
dc.subjectTreatment Outcome
dc.subjectRandomized Controlled Trials as Topic
dc.titleProtocol for the Gut Bugs in Autism Trial: a double-blind randomised placebo-controlled trial of faecal microbiome transfer for the treatment of gastrointestinal symptoms in autistic adolescents and adults.
dc.typeJournal article
pubs.elements-id487067
pubs.organisational-groupCollege of Health
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