Table 3

Primary and secondary outcomes at 12 months (end of follow-up)

NProbioticsNPlaceboMD/RR (95% CI)P value
Primary outcome
AUCCpep431.87 (1.09; 2.64)442.56 (1.24; 4.17)−0.69 (−1.30 to 0.22)0.205
Secondary outcome
C-peptide (ng/mL)430.59 (0.34; 0.84)450.66 (0.30; 1.02)−0.07 (−0.23 to 0.12)0.640
Insulin requirement (U/kg/day)450.54±0.25440.51±0.270.03 (−0.08 to 0.14)*0.619†
HbA1c (%)446.70 (6.20; 7.13)456.70 (6.10; 7.40)0.00 (−0.40 to 0.40)0.928
HbA1c (mmol/mmol)50 (44; 54)50 (43; 57)
IL-1β (fg/mL)450.00 (0.00; 34.57)440.00 (0.00; 53.92)0.00 (−0.00008 to 0.00002)0.693
IL-2 (fg/mL)430.00 (0.00; 0.00)450.00 (0.00; 0.00)0.00 (−0.00002 to 0.00003)0.403
IL-10 (fg/mL)44203.60 (92.80; 407.62)46196.11 (82.32; 339.98)−7.49 (−52.69 to 104.22)0.521
IFN-γ (fg/mL)440.00 (0.00; 0.00)460.00 (0.00; 0.00)0.00 (0.00 to 0.00)0.339
TNF-α (fg/mL)430.00 (0.00; 8.81)430.00 (0.00; 4.75)0.00 (−0.00005 to 0.00001)0.774
Zonulin (ng/mL)45698.48 (638.90; 900.44)44711.92 (612.65; 829.75)−13.44 (−83.50 to 62.52)0.724
BMI-SDS440.03±0.39450.04±0.27−0.01 (−0.15 to 0.13)*0.869†
GADA (IU/mL)443.48 (0.75; 42.93)463.81 (0.90; 24.70)−0.33 (−2.72 to 1.45)0.971
GADA positive, n (%)4430 (68.2)4631 (67.4)1.01 (0.76 to 1.35)‡>0.999§
IA2A (IU/mL)449.30 (1.10; 18.35)463.24 (0.80; 10.23)6.06 (−0.00003 to 7.11)0.079
IA2A positive, n (%)4431 (70.5)4627 (58.7)1.20 (0.88 to 1.63)‡0.345§
ICA positive, n (%)4444 (100.0)4646 (100.0)n/a‡>0.999¶
TSH461.92±0.96462.12±1.06−0.20 (−0.61 to 0.22)*0.352†
fT4460.97±0.12460.94±0.100.03 (−0.01 to 0.08)*0.150†
Thyroid Ab, n (%)4615 (32.6)466 (13.0)2.50 (1.06 to 5.87)‡0.047§
Celiac disease autoimmunity, n (%)441 (2.3)460 (0.0)n/a‡0.489¶
  • 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.

  • *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).

  • ‡RR with 95% CI for nominal variables.

  • §Groups compared with χ2 test.

  • ¶Groups compared with Fisher’s exact test (nominal variables).

  • Ab, antibody; 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; TNF-α, tumor necrosis factor-α; TSH, thyroid-stimulating hormone.