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Table 1 Schedule of study procedures

From: 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

  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   + + +