Table 1.

Timetable of activities planned during the study

	Study period
	T1D onset	Enrolment	Allocation	Postallocation			Close-out
Time point	–60 days	0	0	Day 1	Month 3	Month 6	Month 12
Enrolment:
Eligibility screen		+
Informed consent		+
Allocation			+
Interventions:
Lactobacillus rhamnosus GG and Bifidobacterium lactis Bb12
Placebo
Assessments:
Anthropometric measurement (body weight and height; BMI; Tanner stage)			+		+	+	+
Fasting C-peptide	+
GADA, IA2A, ICA	+					+	+
Total IgA	+
TTGA	+						+
Anti-Tg, anti-TPO, TSH, fT4	+						+
HbA1c	+		+		+	+	+
Interleukins: IL-1, IL-2, IL-10, TNF-α, IFN-γ	+					+	+
C-peptide during mixed-meal test			+			+	+
Gut permeability						+	+
Side effects (eg, abdominal pain, diarrhoea, constipation, vomiting, flatulence)					+	+	+
Severe hypoglycaemia, ketoacidosis					+	+	+
Return of non-used study products						+

anti-Tg, antithyroglobulin antibody; anti-TPO, anti-thyroid peroxidase antibodies; BMI, body mass index; fT4, free thyroxine; GADA, glutamic acid decarboxylase autoantibodies; HbA1c, glycated haemoglobin; IA2A, tyrosine phosphatase autoantibodies; ICA, islet cell cytoplasmic autoantibodies; IFN-γ, interferon gamma; IL, interleukin ; TNF-α, tumour necrosis factor alpha; TSH, thyroid-stimulating hormone; TTGA, tissue transglutaminase antibody.