Table 4

Post hoc analyses

VariablesProbioticsPlaceboMD (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 change0.08±0.170.01±0.210.07 (−0.01 to 0.15)*0.091†
Insulin0–12 months change0.16±0.170.12±0.210.04 (−0.04 to 0.13)*0.291†
Insulin6–12 months change0.24±0.210.13±0.290.11 (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 change0.50 (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 change0.00 (−15.67; 0.00)0.00 (0.00; 6.40)0.00 (−3.23 to −0.00001)0.032
IL-1β6–12 months change0.00 (0.00; 0.00)0.00 (−6.40; 0.00)0.00 (−0.00001 to 3.01)0.355
IL-1β0–12 months change0.00 (−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 change0.00 (0.00; 0.00)0.00 (0.00; 0.00)0.00 (−0.00006 to 0.00004)0.302
IL-26–12 months change0.00 (0.00; 0.00)0.00 (0.00; 0.00)0.00 (−0.00005 to 0.00002)0.702
IL-20–12 months change0.00 (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 change1.37 (−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 change0.00 (0.00; 0.00)0.00 (0.00; 0.00)0.00 (0.00 to 0.00)0.323
IFN-γ6–12 months change0.00 (0.00; 0.00)0.00 (0.00; 0.00)0.00 (0.00 to 0.00)0.339
IFN-γ0–12 months change0.00 (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 change0.00 (0.00; 0.15)0.00 (0.00; 3.26)0.00 (−0.00001 to 0.000001)0.845
TNF-α6–12 months change0.00 (0.00; 0.00)0.00 (0.00; 0.00)0.00 (−0.0001 to 0.00002)0.932
TNF-α0–12 months change0.00 (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 change59.72 (−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±0.490.06±0.46−0.16 (−0.36 to 0.04)*0.119†
BMI-SDS6–12 months change0.09±0.890.33±0.97−0.24 (−0.63 to 0.15)*0.216†
BMI-SDS0–12 months change−0.07±0.620.10±0.50−0.17 (−0.41 to 0.07)*0.153†
GADA (IU/mL)
GADA0–6 months change0.00 (−2.88; 1.20)0.00 (−1.21; 1.56)0.00 (−2.24 to 0.85)0.591
GADA6–12 months change0.00 (−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 change0.00 (−7.30; 1.60)0.00 (−5.15; 0.68)0.00 (−2.69 to 1.60)0.977
IA2A 6–12 months change0.00 (−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.