Table 2

Primary and secondary outcomes at 6 months (end of intervention)

NProbioticsNPlaceboMD/RR (95% CI)P value
Primary outcome
AUCCpep443.38 (2.24; 4.52)443.30 (2.14; 4.56)0.08 (−0.80 to 0.78)0.993
Secondary outcomes
C-peptide (ng/mL)440.89 (0.61; 1.15)440.94 (0.57; 1.17)−0.05 (−0.18 to 0.20)0.832
Insulin requirement (U/kg/day)440.36±0.23440.39±0.25−0.03 (−0.13 to 0.08)*0.626†
HbA1c (%)456.20 (5.60; 6.60)456.50 (5.90; 7.05)−0.30 (−0.60 to 0.00006)0.058
HbA1c (mmol/mmol)44 (38; 49)49 (41; 54)
IL-1β (fg/mL)440.00 (0.00; 8.02)430.00 (0.00; 26.45)0.00 (−0.00004 to 0.00004)0.241
IL-2 (fg/mL)440.00 (0.00; 1.02)440.00 (0.00; 0.00)0.00 (−0.00007 to 0.00004)0.472
IL-10 (fg/mL)45222.86 (42.78; 323.11)45159.06 (33.64; 295.69)63.80 (−41.38 to 87.44)0.470
IFN-γ (fg/mL)450.00 (0.00; 0.00)450.00 (0.00; 0.00)0.00 (0.00 to 0.00)n/a
TNF-α (fg/mL)440.00 (0.00; 5.66)420.00 (0.00; 18.79)0.00 (−0.00001 to 0.0001)0.594
Zonulin (ng/mL)44673.72 (537.71; 827.21)46761.80 (634.79; 838.74)−88.08 (−138.42 to 39.46)0.294
BMI-SDS450.06±0.92450.32±0.91−0.26 (−0.65 to 0.12)*0.178†
GADA (IU/mL)457.43 (0.94; 38.90)445.97 (1.16; 32.98)1.46 (−2.87 to 5.33)0.924
GADA positive, n (%)4533 (73.3)4433 (75.0)0.98 (0.77 to 1.25)‡>0.999§
IA2A (IU/mL)458.20 (1.92; 15.20)444.75 (0.80; 14.75)3.45 (−1.53 to 4.74)0.509
IA2A positive, n (%)4533 (75.0)4427 (61.4)1.96 (0,89 to 1.60)‡0.328§
ICA positive, n (%)4545 (100.0)4444 (100.0)n/a‡>0.999¶
  • Values are expressed as means±SD or median with lower and upper quartile (Q1; Q3), unless otherwise indicated.

  • P<0.05 was considered as significant.

  • *Mean 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).

  • ‡RR with 95% CI for nominal variables.

  • §Groups compared with χ2 test.

  • ¶Groups compared with Fisher’s exact test (nominal 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; ICA, islet cell antibodies; IFN-γ, interferon-gamma; IL, interleukin; MD, mean difference or median difference; n/a, not available; RR, relative risk; SDS, SD scores; TDD, total daily insulin dose; TNF-α, tumour necrosis factor-α.