Evidence map›Paper›PMID 42451083›Full record

Trial reportNutrients2026

Effect of Probiotic Supplementation on Gut Microbiota in Children with Autism: A Pilot Randomised Controlled Trial.

Sachin Agrawal, Shripada Rao, Andrew Whitehouse, Gail A Alvares, Alpana Kulkarni, Jessica A Taylor, Patricia L Conway, Torsten Thomas, Sanjay Patole

Abstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Nutrients, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Sachin AgrawalNeonatal Directorate, King Edward Memorial Hospital for Women, Perth, WA 6008, Australia.
Shripada RaoSchool of Medicine, The University of Western Australia, Perth, WA 6009, Australia.
Andrew WhitehouseThe Kids Research Institute Australia, Nedlands, WA 6009, Australia.
Gail A AlvaresThe Kids Research Institute Australia, Nedlands, WA 6009, Australia.
Alpana KulkarniFremantle Child Development Service, Perth, WA 6163, Australia.
Jessica A TaylorPC Biome, NTU Innovation Centre, Nanyang Technological University, Singapore 638075, Singapore.
Patricia L ConwayCentre for Marine Science and Innovation and School of Biological, Earth and Environmental Sciences, University of New South Wales (UNSW), Sydney, NSW 2052, Australia.
Torsten ThomasCentre for Marine Science and Innovation and School of Biological, Earth and Environmental Sciences, University of New South Wales (UNSW), Sydney, NSW 2052, Australia.ORCID 0000-0001-9557-3001
Sanjay PatoleNeonatal Directorate, King Edward Memorial Hospital for Women, Perth, WA 6008, Australia.ORCID 0000-0003-2651-1477

Funding

Perth children hospital foundation 10094
6 · The paper itself

Abstract

backgroundDysbiosis of the gut microbiota is common in children with autism spectrum disorder (ASD). Probiotics have the potential to improve outcomes in ASD by modulating the gut microbiota-brain axis.

methodsIn a pilot randomised trial, children (2 to 5 years) with confirmed ASD (DSM-5 criteria) received either a multi-strain probiotic (450 billion CFU twice daily for one month, followed by once daily for three months) or placebo supplementation. Faecal microbiota profiles were assessed using pre- and post-supplementation samples. The primary outcome involved changes in gut microbiota diversity. Secondary outcomes included faecal short-chain fatty acid levels and behavioural changes.

resultsDifficulties in recruitment and loss to follow-up for reasons including COVID-19 resulted in the enrolment of only 23 (probiotic: 9; placebo: 14) instead of the planned 40 children. There was no evidence of changes in the gut microbiota in probiotic-supplemented children. The common phyla were Bacillota_A (~50%), Bacteroidota (~18%) and Actinobacteriota (~10%). Alpha- and Beta-diversity showed no significant difference between pre- vs. post-supplementation samples. Bifodobacteriaceae increased significantly in the probiotic-supplemented group (

conclusionsThe increase in faecal Bifodobacteriaceae supports an evaluation of probiotics in ASD. Addressing the reasons for loss to follow-up is important when designing trials in this field.

Indexed as

Autism Spectrum DisorderDietary SupplementsGastrointestinal MicrobiomeProbioticsAutistic DisorderChild, PreschoolDysbiosisFatty Acids, VolatileFecesFemaleHumansMalePilot ProjectsTreatment OutcomeFatty Acids, Volatileautism spectrum disorderbehaviormicrobiotaprobiotics

Identifiers

PMID42451083
PMCPMC13363267

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.