Review Article

Efficacy of Faecal Microbiota Transplantation for the Treatment of Autism in Children: Meta-Analysis of Randomised Controlled Trials

Table 1

Characteristics of included studies on humans.

ReferencePopulationStudy designSampleTherapyTreatment timeFollow-upafter FMTAdministration routeGI effects of treatmentNeurological effects of treatment

Kang et al. [21]Autism Society of Greater Phoenix and the Autism/Asperger’s Research Program at Arizona State University, USAOpen-label clinical trialASD group:18 control group: 20MTT10 weeks8 weeks12 oral
6 rectal
GSRS: 77% decrease
DSR showed significant decreases in the number of days with abnormal or no stools
CARS: decreased by 22% from the beginning to the end of the treatment and 24% after 8 weeks of no treatment
SRS and ABC improvement after FMT

Kang et al. [22]Autism Society of Greater Phoenix and the Autism/Asperger’s Research Program at Arizona State University, USAOpen-label clinical trialASD group: 18 control group: 20MTT10 weeks2 year12 oral
6 rectal
GSRS: 58% reduction
DSR: 26% reduction
CARS: the severity of ASD at the two-yearfollow-up was 47% lower than baseline
SRS: 44% of participants were below the ASD diagnostic cut-off scores
ABC: total scores continued to improve, and were 35% lower relative to baseline
Li et al. [23]Department of Gastroenterology, Daping Hospital, ChinaOpen-label clinical trialASD group: 40
TD group: 16
FMT4 week8 week27 oral route
13 colonic
GSRS and DSR decreased after 4 weeks of FMT treatment and last for the next 8 weeksABC: significantly alleviated by the treatment, and no obvious reversion was observed during 8 weeks after FMT
CARS: decreased by 10% at the end of the treatment and remained decreased by 6% after 8 weeks
SRS: parents’ anxiety levels decreased decreased and social skill deficits improved at the end of treatment but reversed after 8 weeks without further treatment

Kong et al. [24]Community recruited population, USARandomisation and blinding clinical trialProbiotic group: 18
placebo group: 17
Probiotic and oxytocin combination therapies28 weeksOralGIS showed no significant changesTrends of improvement in the total ABC score, stereotypic behaviour score, and SRS cognition score were observed in the combination therapy group (probiotic + OXT), although no significant differences were observed in the total scores or subscales of the ABC and SRS

Luo [25]Autism Rehabilitation Training Institution, ChinaRandomisation and blinding clinical trial4 ASDFMT1 dayTwo monthsGastroscopic, colonoscopyNoneThe ABC scores decreased by an average of 25% after FMT
Zhao et al. (abstract only) [26]Hospital recruited population, ChinaOpen-label, randomised waitlist-controlled trialFMT group: 24
Waitlist group: n = 21
FMT group received twice FMT; waitlist group received rehabilitation trainingTwo monthsTwo monthsColonoscopy, gastroscopyNotable differences were also shown on GSI scores at F1 time pointCARS score in FMT group decreased 10.8%
Waitlist group decreased 0.8% after the first FMT, and remained reduced after the second FMT

Grimaldi et al. [27]Hospital recruited population, USAA randomised, double-blind, placebo-controlled, parallel-designed prebiotic clinical trialUnrestricted diet group (Prebiotics: 7; placebo: 7)
exclusion diet group (prebiotics: 6; placebo: 6)
Bimuno galactooligosaccharide6 weeks2 weeksOralA general trend of reduction in GI problems was reported, differences between treatments were not significantSignificant improvement in social behaviour scores

Santocchi et al. [28]The Child and Adolescence Mental Health services of Tuscany Region sd, Unit of Child Psychiatry and the Unit of Child Rehabilitation of IRCCS, Pisa, ItalyA randomised, blind, clinical trialProbiotics: 42 placebo: 43Probiotic preparation6 months0OralGreater improvements in some GI symptoms, adaptive functioning, and sensory profiles than in the GI group treated with a placeboPotentially positive effects of probiotics on core autism symptoms in a subset of ASD children

Linda et al. (abstract only) [29]ASD subjectsCase series9 ASDFMTUnclearUnclearCapsules, enemaNAASD symptoms: unchanged in 21y.o., improved in one of two 8y.o., improved in younger subjects on a more long-lasting basis. Frequent regression, mostly after AB post-FMT, often improved after re-FMT