Primary and secondary outcomes at 6 months (end of intervention)
| N | Probiotics | N | Placebo | MD/RR (95% CI) | P value | |
| Primary outcome | ||||||
| AUCCpep | 44 | 3.38 (2.24; 4.52) | 44 | 3.30 (2.14; 4.56) | 0.08 (−0.80 to 0.78) | 0.993 |
| Secondary outcomes | ||||||
| C-peptide (ng/mL) | 44 | 0.89 (0.61; 1.15) | 44 | 0.94 (0.57; 1.17) | −0.05 (−0.18 to 0.20) | 0.832 |
| Insulin requirement (U/kg/day) | 44 | 0.36±0.23 | 44 | 0.39±0.25 | −0.03 (−0.13 to 0.08)* | 0.626† |
| HbA1c (%) | 45 | 6.20 (5.60; 6.60) | 45 | 6.50 (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) | 44 | 0.00 (0.00; 8.02) | 43 | 0.00 (0.00; 26.45) | 0.00 (−0.00004 to 0.00004) | 0.241 |
| IL-2 (fg/mL) | 44 | 0.00 (0.00; 1.02) | 44 | 0.00 (0.00; 0.00) | 0.00 (−0.00007 to 0.00004) | 0.472 |
| IL-10 (fg/mL) | 45 | 222.86 (42.78; 323.11) | 45 | 159.06 (33.64; 295.69) | 63.80 (−41.38 to 87.44) | 0.470 |
| IFN-γ (fg/mL) | 45 | 0.00 (0.00; 0.00) | 45 | 0.00 (0.00; 0.00) | 0.00 (0.00 to 0.00) | n/a |
| TNF-α (fg/mL) | 44 | 0.00 (0.00; 5.66) | 42 | 0.00 (0.00; 18.79) | 0.00 (−0.00001 to 0.0001) | 0.594 |
| Zonulin (ng/mL) | 44 | 673.72 (537.71; 827.21) | 46 | 761.80 (634.79; 838.74) | −88.08 (−138.42 to 39.46) | 0.294 |
| BMI-SDS | 45 | 0.06±0.92 | 45 | 0.32±0.91 | −0.26 (−0.65 to 0.12)* | 0.178† |
| GADA (IU/mL) | 45 | 7.43 (0.94; 38.90) | 44 | 5.97 (1.16; 32.98) | 1.46 (−2.87 to 5.33) | 0.924 |
| GADA positive, n (%) | 45 | 33 (73.3) | 44 | 33 (75.0) | 0.98 (0.77 to 1.25)‡ | >0.999§ |
| IA2A (IU/mL) | 45 | 8.20 (1.92; 15.20) | 44 | 4.75 (0.80; 14.75) | 3.45 (−1.53 to 4.74) | 0.509 |
| IA2A positive, n (%) | 45 | 33 (75.0) | 44 | 27 (61.4) | 1.96 (0,89 to 1.60)‡ | 0.328§ |
| ICA positive, n (%) | 45 | 45 (100.0) | 44 | 44 (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.