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. |