Variables | Probiotics | Placebo | MD (95% CI) | P value |
AUCCpep | ||||
AUCCpep (0–6 months change) | −1.46 (−2.91; 0.17) | −0.38 (−1.86; 0.41) | −1.08 (−1.74 to 0.43) | 0.174 |
AUCCpep (6–12 months change) | 0.20 (−0.73; 1.06) | 0.35 (−0.19; 1.36) | −0.15 (−0.93 to 0.34) | 0.330 |
AUCCpep (0–12 months change) | −3.10 (−3.74; 1.08) | −1.60 (−3.58; −0.53) | −1.50 (−1.77 to 0.45) | 0.254 |
Insulin (U/kg/day) | ||||
Insulin0–6 months change | 0.08±0.17 | 0.01±0.21 | 0.07 (−0.01 to 0.15)* | 0.091† |
Insulin0–12 months change | 0.16±0.17 | 0.12±0.21 | 0.04 (−0.04 to 0.13)* | 0.291† |
Insulin6–12 months change | 0.24±0.21 | 0.13±0.29 | 0.11 (0.004 to 0.22)* | 0.042† |
HbA1c (%) | ||||
HbA1c0–6 months change | −1.65 (−2.13; 0.68) | −1.40 (−2.60; −0.50) | −0.25 (−0.60 to 0.70) | 0.956 |
HbA1c6–12 months change | 0.50 (0.10; 0.95) | 0.00 (0.35; 0.60) | 0.50 (0.10 to 0.70) | 0.009 |
HbA1c0–12 months change | −1.05 (−1.88; 0.30) | −1.10 (−2.90; −0.20) | −0.05 (−0.40 to 1.00) | 0.396 |
IL-1β (fg/mL) | ||||
IL-1β0–6 months change | 0.00 (−15.67; 0.00) | 0.00 (0.00; 6.40) | 0.00 (−3.23 to −0.00001) | 0.032 |
IL-1β6–12 months change | 0.00 (0.00; 0.00) | 0.00 (−6.40; 0.00) | 0.00 (−0.00001 to 3.01) | 0.355 |
IL-1β0–12 months change | 0.00 (−34.86; 0.00) | 0.0 (−4.88; 0.00) | 0.00 (−2.68 to 0.00001) | 0.256 |
IL-2 (fg/mL) | ||||
IL-20–6 months change | 0.00 (0.00; 0.00) | 0.00 (0.00; 0.00) | 0.00 (−0.00006 to 0.00004) | 0.302 |
IL-26–12 months change | 0.00 (0.00; 0.00) | 0.00 (0.00; 0.00) | 0.00 (−0.00005 to 0.00002) | 0.702 |
IL-20–12 months change | 0.00 (0.00; 0.00) | 0.00 (0.00; 0.00) | 0.00 (−0.00005 to 0.00004) | 0.951 |
IL-10 (fg/mL) | ||||
IL-100–6 months change | −51.82 (164.13; 26.37) | −26.87 (−126.09; 30.20) | −24.95 (−96.69 to 44.38) | 0.445 |
IL-106–12 months change | 1.37 (−72.90; 129.76) | 7.01 (−40.51; 122.01) | −5.64 (−63.95 to 71.38) | 0.974 |
IL-100–12 months change | −22.94 (−127.67; 62.53) | −20.15 (−164.32; 99.09) | −2.79 (−90.37 to 81.52) | 0.933 |
IFN-γ (fg/mL) | ||||
IFN-γ0–6 months change | 0.00 (0.00; 0.00) | 0.00 (0.00; 0.00) | 0.00 (0.00 to 0.00) | 0.323 |
IFN-γ6–12 months change | 0.00 (0.00; 0.00) | 0.00 (0.00; 0.00) | 0.00 (0.00 to 0.00) | 0.339 |
IFN-γ0–12 months change | 0.00 (0.00; 0.00) | 0.00 (0.00; 0.00) | 0.00 (−0.0001 to 0.0001) | >0.999 |
TNF-α (fg/mL) | ||||
TNF-α0–6 months change | 0.00 (0.00; 0.15) | 0.00 (0.00; 3.26) | 0.00 (−0.00001 to 0.000001) | 0.845 |
TNF-α6–12 months change | 0.00 (0.00; 0.00) | 0.00 (0.00; 0.00) | 0.00 (−0.0001 to 0.00002) | 0.932 |
TNF-α0–12 months change | 0.00 (0.00; 1.29) | 0.00 (0.00; 0.00) | 0.00 (−0.0001 to 2.57) | 0.383 |
Zonulin (ng/mL) | ||||
Zonulin6–12 months change | 59.72 (−23.12; 145.15) | 7.71 (−93.22; 71.59) | 52.01 (−7.00 to 128.62) | 0.079 |
BMI-SDS | ||||
BMI-SDS0–6 months change | −0.10±0.49 | 0.06±0.46 | −0.16 (−0.36 to 0.04)* | 0.119† |
BMI-SDS6–12 months change | 0.09±0.89 | 0.33±0.97 | −0.24 (−0.63 to 0.15)* | 0.216† |
BMI-SDS0–12 months change | −0.07±0.62 | 0.10±0.50 | −0.17 (−0.41 to 0.07)* | 0.153† |
GADA (IU/mL) | ||||
GADA0–6 months change | 0.00 (−2.88; 1.20) | 0.00 (−1.21; 1.56) | 0.00 (−2.24 to 0.85) | 0.591 |
GADA6–12 months change | 0.00 (−1.50; 0.40) | −1.11 (−4.63; 0.00) | 1.11 (−0.0001 to 2.64) | 0.051 |
GADA0–12 months change | −0.03 (−6.20; 0.24) | −0.31 (−2.65; 0.17) | 0.28 (−1.16 to 3.70) | 0.622 |
IA2A (IU/mL) | ||||
IA2A0–6 months change | 0.00 (−7.30; 1.60) | 0.00 (−5.15; 0.68) | 0.00 (−2.69 to 1.60) | 0.977 |
IA2A 6–12 months change | 0.00 (−0.98; 1.35) | −0.50 (−3.40; 0.00) | 0.50 (0.15 to 3.20) | 0.004 |
IA2A0–12 months change | −0.20 (−9.38; 1.67) | −0.23 (−6.83; 0.00) | 0.03 (−1.48 to 3.36) | 0.448 |
Values are expressed as means±SD or median with lower and upper quartile (Q1; Q3).
*MD between groups for continuous variables (depending on normality of data) calculated as probiotic group minus placebo group with 95% CI.
†Groups compared with t-test or with Mann-Whitney U test (remaining variables).
AUCCpep, area under the curve of the C-peptide level during 2-hour responses to a mixed meal; BMI, body mass index; GADA, glutamic acid decarboxylase antibodies; HbA1c, glycated hemoglobin; IA2A, antityrosine phosphatase antibodies; IFN-γ, interferon-gamma; IL, interleukin; MD, mean difference or median difference; SDS, SD scores; TDD, total daily insulin dose; TNF-α, tumor necrosis factor-α.