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. 2020 Feb 11;21:161. doi: 10.1186/s13063-019-4040-x

Table 1.

Inclusion and exclusion criteria of the PROBIA trial

Inclusion criteria Both males and females aged 18–65 years
A high level of multidimensional impulsivity based on both a Clinical Global Impression–Severity Scale (CGI-S) score ≥ 4 and an Affective Reactivity Index (ARI) ≥ 5
DSM-5 criteria for attention deficit/hyperactivity disorder (ADHD) and/or borderline personality disorder (BPD) confirmed by a structured diagnostic interview (ADHD: Diagnostic Interview for Adult ADHD [DIVA 2.0]; BPD: Structured Clinical Interview for DSM-IV [SCID-II])
Deemed reliable and compliant with the protocol by the investigator
Ability to speak and comprehend the native language of the country in which the assessments take place
Informed consent signed
Exclusion criteria Antibiotherapy within the last 6 weeks prior to study
Currently taking probiotics
Presence of a major psychiatric disorder with psychotic symptoms or other major psychiatric conditions requiring hospitalization (e.g., significant mood disorders)
Neurological disorders involving central functions (e.g., epilepsy, multiple sclerosis, narcolepsy)
Intelligence quotient (IQ) < 70 (measured by WAIS, if available)
Major physical illnesses of the cardiovascular, endocrine, pulmonal, immune, or gastrointestinal system or undergoing immunosuppression
History of/present clinically relevant somatic acute or chronic disorders that, in the opinion of the investigator, might confound the results of tolerability/safety assessments or prohibit the patient from completing the study or would not be in the best interest of the patient
Documented allergy, hypersensitivity, or intolerance to any of the ingredients of the intervention
Subject has taken another investigational product or taken part in a clinical study within 30 days prior to entering the study.

Abbreviations: DSM Diagnostic and Statistical Manual of Mental Disorders, PROBIA Treatment of impulsivity in adults with probiotics, WAIS Wechsler Adult Intelligence Scale