Table 2.
Efficacy Measures at Baseline and 6-Months in the Two Treatment Groups.
| Placebo (32) | Probiotics (31) | p ANOVA Pla/Pro T0 | p ANOVA Pla/Pro T0-T2 | |||||
|---|---|---|---|---|---|---|---|---|
| Characteristics | T0 | T2 | Change T0-T2 | T0 | T2 | Change T0-T2 | ||
| Age, mean (SD), y | 4.09 (0.97) | 4.62 (0.98) | 0.52 | 4.29 (1.22) | 4.82 (1.23) | 0.53 | ns | ns |
| Boys, No. (%) | 27 (84.4) | 27 (84.4) | n. a. | 24 (77.4) | 24 (77.4) | n. a. | ns | ns |
| BMI m (DS) | 16.06 (1.73) | 15.91 (1.76) | -0.15 | 15.95 (1.93) | 16.01 (2.18) | 0.06 | ns | ns |
| Melatonin supplementation n (%) | 2 (6.25) | 3 (9.7) | ns | |||||
| Vitamin supplementation | 3 (9.4) | 7 (22.6) | ns | |||||
| ADOS CSS a | ||||||||
| Total | 6.97 (1.91) | 7.00 (1.80) | 0.03 | 6.84 (1.39) | 6.19 (1.56) | -0.65 | ns | ns |
| Social Affect | 6.41(2.21) | 6.09 (1.82) | -0.31 | 6.26 (1.79) | 5.35 (1.56) | -0.90 | ns | ns |
| Restricted and repetitive behavior | 8.22(1.31) | 8.53 (1.34) | 0.31 | 7.94 (1.57) | 8.23 (1.45) | 0.29 | ns | ns |
| SCQ b | 16.06(5.54) | 13.90 (6.19) | -2.16 | 12.83 (6.68) | 11.97 (6.71) | -0.87 | 0.042 | ns |
| RBS-R c | 22.31 (15.47) | 19.13 (12.10) | -3.18 | 18.32 (13.17) | 14.37 (8.01) | -3.96 | ns | ns |
| DQ d , standardized test | ||||||||
| General Quotient | 62.29 (20.12) | 61.14 (20.13) | -1.15 | 65.91 (18.06) | 69.27 (20.09) | 3.36 | ns | ns |
| VABS II e | ||||||||
| Composite Score | 57.00 (16.74) | 59.72 (16.38) | 2.72 | 63.87 (22.12) | 67.39 (22.29) | 3.52 | ns | ns |
| CBCL f | ||||||||
| Total Problems | 62.84 (10.97) | 57.30 (9.05) | -5.54 | 60.94 (9.94) | 57.80 (7.92) | -3.14 | ns | ns |
| PSI g | ||||||||
| Total Stress | 74.76 (24.98) | 61.03 (32.58) | -13.72 | 70.03 (29.63) | 66.62 (31.15) | -3.41 | ns | ns |
| GI Severity Index h | ||||||||
| Total 6-GSI | 1.38 (1.45) | 1.29 (1.19) | -0.08 | 2.06 (2.14) | 1.23 (1.48) | -0.83 | ns | ns |
| Total GSI | 2.91 (2.19) | 2.16 (1.57) | -0.74 | 3.61 (2.92) | 2.53 (2.19) | -1.08 | ns | ns |
| Linguistic Level i | Pla T0-T2 (%) | Pro T0-T2 (%) | ||||||
| ↓ | = | ↑ | ↓ | = | ↑ | |||
| 0 | 87.50 | 12.50 | 9.68 | 70.97 | 19.35 | ns | ns | |
ADI-R, Autism Diagnostic Interview–Revised; ADOS, Autism Diagnostic Observation Schedule; CBCL, 1.5-5 Child Behavior Checklist 1.5-5; CSS, Calibrated Severity Score; D, Definite Difference; GI, gastrointestinal; GSI, Gastrointestinal Severity Index; IQ, Intelligence Quotient; No., Number; NGI, Non-Gastrointestinal; Pla, Placebo; Pro, Probiotics; P, Probable Difference; PSI, Parental Stress Index; RBS-R, Repetitive Behaviors Scale-Revised; SCQ, Social Communication Questionnaire; SD, Standard Deviation; T, Typical Performance; VABS-II, Vineland Adaptive Behavior Scales-II. is to be understood as worsened compared to the previous evaluation, = is to be understood as unchanged from the previous evaluation, ↑ is to be understood as improved compared to the previous evaluation. Means, and standard deviations are reported.
Higher scores indicate greater severity (range of possible scores for Total, Social Affect and Restricted and Repetitive Behavior is 1-10).
Higher scores indicate greater severity (range 0-39) with a threshold of 15 compatible for a relevant impairment of social communication (some studies consider 9 in children younger than four years old).
Higher scores indicate greater severity of repetitive behaviors (range 0-114).
Higher scores indicate greater cognitive ability. Scores around 100 indicate normal intelligence; scores below 70 indicate a developmental delay.
Higher scores indicate greater adaptive competences. Scores around 100 indicate normal adaptive capacities; scores below 70 indicate a delay with respect to age.
Higher scores indicate greater severity; a score of 63 and above is generally considered clinically significant.
Higher scores indicate greater severity of parental stress index caused both by characteristics of the child and by negative experiences about the parenting role (Total Stress).
Higher scores indicate greater severity of gastrointestinal symptoms; Total 6-GSI has a range of 0 to 12, Total GSI has a range of 0 to 17.
The “Overall Level of Non-Echoed Spoken Language” item (A1 score) of the ADOS-2 was used to differentiate non-verbal (those with absent language or less than 5 words) from verbal children.