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Table 1 Summary of characteristics of studies in the current meta-analysis

From: The therapeutic effects of probiotics on core and associated behavioral symptoms of autism spectrum disorders: a systematic review and meta-analysis

Study (year)

Diagnosis

(Criteria)

Design

Comparison

N

Duration (weeks)

Outcome

Psychotropic medications

Mean age (years)

Female (%)

Country

Billeci

(2023)

ASD

(DSM-5)

RCT

Probiotics: multiple strains

20

24

1.Overall = ADOS CSS

2.Adaptation = VABS-II

Allow

3.88

(1.5–6)

23.9

Italy

Placebo

26

Liu

(2023)

ASD

(DSM-5)

RCT

Probiotics: single strain

41

8

1.Overall = ASEBA

2.Irritability = ASEBA aggression

4.Hyperactivity = ADHDT

5.Inattention = ADHDT

6.Anxiety = ASEBA anxiety

Allow only psychostimulant

4.82

(2.5–7)

12.2

Taiwan

Placebo

41

Schmitt

(2023)

ASD

(DSM-5)

RCT/

Crossover

Probiotics: single strain

15

4

1.Overall = CGI-S

2.RRB = ABC Stereotype

3.Social = ABC lethargy

4.Communication = ABC inappropriate speech

5.Irritability = ABC Irritability

6.Hyperactivity = ABC Hyperactivity

7.Adaptation = Vineland adaptive behavior composite score

Allow

20

(15–45)

0

USA

Placebo

15

Kong

(2021)

ASD

(DSM-IV TR/−5)

RCT

Probiotics: single strain

18

16

1.Overall = ABC total

2.RRB = ABC Stereotype

3.Social = ABC lethargy

4.Communication = ABC inappropriate speech

5.Irritability = ABC Irritability

6.Hyperactivity = ABC Hyperactivity

Allow

10.26

(3–25)

25.8

USA

Placebo

17

Li

(2021)

ASD

(DSM-5)

RCT

Probiotics: multiple strains + ABA

21

12

1.Total = ATEC

2.Social = ATEC social behaviors

3.Communication = ATEC communication

Allow

4.55

(3–6)

24.4

China

ABA only

20

Santocchi (2020)

ASD

(DSM-5)

RCT

Probiotics: multiple strains

6

24

1.Total = ADOS CSS

2.Social = ADOS Social affect

3.RRB = ADOS RRB

4.Adaptation = VABS-II

5.Parental stress = PSI

Allow

4.14

(1.5–6)

16.4

Italy

Placebo

4

Arnold

(2019)

ASD

(DSM-5)

RCT/

Crossover

Probiotics: multiple strains

31

8

1.Overall = SRS total

2.RRB = ABC Stereotype

3.Social = ABC lethargy

4.Communication = ABC inappropriate speech

5.Irritability = ABC Irritability

6.Hyperactivity = ABC Hyperactivity

7.Parental stress = PSI

8.Anxiety = PRAS-ASD total

Allow

8.85

(3–12)

40

USA

Placebo

32

Liu

(2019)

ASD

(DSM-5)

RCT

Probiotics: single strain

36

4

1.Overall = ABC-T total

2.RRB = SRS autism mannerism

3.Social = ABC-T social and self-help

4.Communication = SRS social communication

5.Irritability = CBCL aggressive behaviors

6.Hyperactivity = SNAP-IV

7. Inattention = SNAP-IV

8.Anxiety = CBCL anxiety

Allow

10.01

(7–15)

0

Taiwan

Placebo

35

Sanctuary

(2018)

ASD

(ADOS)

RCT/

Crossover

Probiotics: single strain + BCP

8

5

1.Overal = ABC total score

2.RRB = ABC Stereotype

3.Social = ABC lethargy

4.Irritability = ABC Irritability

5.Hyperactivity = ABC Hyperactivity

Allow

6.8

(2–11)

12.5

USA

BCP

8

Emmanuel NCT03369431

ASD

(ADI-R, DISCO, ADOS)

RCT/

Crossover

Probiotics: multiple strains

64

12

1.Overall = ATEC total

2.RRB = ABC Stereotype

3.Social = ABC lethargy

4.Irritability = ABC Irritability

5.Hyperactivity = ABC Hyperactivity

6.Communication = ABC inappropriate speech

7.Parental stress = APSI

Allow

7.8

(3–16)

17.4

UK

Placebo

64

  1. ABA applied behavior analysis; ABC aberrant behavior checklist; ABC-T aberrant behavior checklist-Taiwan version; ADHDT attention-deficit/hyperactivity disorder test; ADI-R autism diagnostic interview-revised; ADOS autism diagnostic observation schedule; ADOS CSS autism diagnostic observation schedule calibrated severity score; APSI autism parenting stress index; ASD autistic spectrum disorder; ASEBA Achenbach system of empirically based assessment; ATEC autism treatment evaluation checklist; CBCL child behavior checklist; CGI-S clinical global impressions scale– severity; BCP bovine colostrum product; DISCO diagnostic interview for social and communication disorders; DSM-IV-TR diagnostic and statistical manual of mental disorders, fourth edition, text revision; DSM-5 diagnostic and statistical manual of mental disorders fifth edition; N number; PRAS-ASD total parent-rated anxiety scale for ASD; PSI parenting stress index; RCT randomized controlled trial; RRB restricted repetitive behaviors; SNAP-IV Swanson, Nolan and Pelham (SNAP)-IV-Taiwan version; SRS social reporting standard; VABS-II Vineland Adaptive Behavior Scales-II