The study evaluating the effect of probiotic supplementation on the mental status, inflammation, and intestinal barrier in major depressive disorder patients using gluten-free or gluten-containing diet (SANGUT study): a 12-week, randomized, double-blind, and placebo-controlled clinical study protocol

Table 1 Schedule of study procedures

	Screening	Randomization	Intervention Period	End of the study
Visit Number	V0	V1	V2	V3
Visit time and Window	Day –7 to –1	Day 0	6 weeks ±3 days	12 weeks ±3 days
Informed consent	+
Inclusion/exclusion criteria	+	+
Somatic examination	+	+
Neurological examination	+	+
Socio-demographic characteristics	+
Medical history	+
Psychiatric history	+
Depression symptoms severity	+	+	+	+
Stress level	+	+	+	+
Quality of life	+	+	+	+
Gastrointestinal symptoms	+	+	+	+
Dietary assessment	+	+	+	+
Physical activity	+	+	+	+
Anthropometric measures	+	+	+	+
Vital measures	+	+	+	+
Smoking status	+	+	+	+
Blood sample	+			+
Stool sample	+			+
Electroencephalography	+			+
Adverse events report		+	+	+

ISSN: 1475-2891