Table 1

Baseline characteristics

VariableProbioticsPlacebo
n4848
Female, n (%)23 (47.9)18 (37.5)
Age (years)12.31±2.1313.17±2.59
Height (SDS)0.62±1.010.64±1.02
Height (cm)156.64±11.91160.66±14.79
Weight, SDS0.42±0.800.50±0.88
Weight (kg)47.50±10.2253.01±15.54
BMI (SDS)0.20±0.840.24±1.02
Time from diagnosis to recruitment, days (SD)40.4±16.229.65±19.6
Tanner scale (4–5), n (%)12 (25.0)16 (33.3)
AUCCpep4.68 (3.55; 6.98)3.90 (2.93; 6.89)
C-peptide (ng/mL), median (Q1; Q3)1.03 (0.75; 1.37)0.97 (0.60; 1.54)
Insulin requirement (U/kg body mass)0.29±0.170.36±0.2
Basal insulin (% of TDD), median (Q1; Q3)29.31 (17.80; 44.77)25 (16.44; 42.81)
HbA1c (%)7.8 (7.08; 8.30)8.10 (7.30; 9.70)
HbA1c (mmol/mol), median (Q1; Q3)65 (56; 83)62 (54; 67)
IL-1β (fg/mL), median (Q1; Q3)0.00 (0.00; 79.39)0.00 (0.00; 39.17)
IL-2 (fg/mL), median (Q1; Q3)0.00 (0.00; 0.88)0.00 (0.00; 0.00)
IL-10 (fg/mL), median (Q1; Q3)281.69 (99.04; 465.96)151.09 (73.27; 370.84)
IFN-γ (fg/mL), median (Q1; Q3)0.00 (0.00; 0.00)0.00 (0.00; 0.00)
TNF-α (fg/mL), median (Q1; Q3)0.00 (0.00; 18.22)0.00 (0.00; 14.71)
GADA (IU/mL), median (Q1; Q3)7.16 (0.78; 48.05)5.81 (1.7; 24.03)
GADA positive, n (%)35 (72.9)38 (79.2)
IA2A (IU/mL), median (Q1; Q3)12.3 (1.11; 21.13)3.99 (0.8; 21.8)
IA2A positive, n (%)33 (68.8)30 (62.5)
ICA positive, n (%)45 (93.8)48 (100.0)
TSH2.08±0.952.22±1.22
fT41.02±0.111.03±0.13
Thyroid antibodies, n (%)20 (41.7)10 (20.8)
Celiac autoimmunity, n (%)0 (0.0)0 (0.0)
  • AUC, area under the curve of the C-peptide 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; SDS, SD scores; TDD, total daily insulin; TNF-α, tumor necrosis factor-α; TSH, thyroid-stimulating hormone.