Treating impulsivity with probiotics in adults (PROBIA): study protocol of a multicenter, double-blind, randomized, placebo-controlled trial

Table 3 Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) schematic schedule of enrollment, interventions, and assessments

Study procedures		Screening	Open label			Follow-up
	Visit	TS	T0	T1	T2	T3
	Week	−1	1	5	10	11
	Day	−7 to −1	1	35 ± 2	70 ± 2	77 ± 2
Informed consent form		X
Inclusion/exclusion criteria		X
Demographics (including SES)		X
IQ (IQ score based on WAIS, if available)		X
M.I.N.I.-Plus assessment		X
Confirmation of diagnosis/-es		X
Confirmation of ADHD	DIVA 2.0	X
Confirmation of BPD	SCID-II	X
Primary outcome
Clinical Global Impression–Improvement Scale	CGI-I			X	X	X
Affective Reactivity Index	ARI-S	X	X	X	X	X
Secondary outcomes
Clinical Global Impression–Severity Scale	CGI-S	X	X	X	X
Clinician rating of ADHD symptoms	ADHD-RS		X	X	X
Self-rating of multidimensional impulsivity	UPPS-P		X	X	X
Questionnaire on well-being			X		X
Functioning Assessment Short Test	FAST		X	X	X
Self/other rating of strength and difficulties	SDQ		X	X	X
Clinician rating of compulsivity	Y-BOCS		X	X	X
Sleep problems	5-item questionnaire		X	X	X
Self-rating of emotion regulation difficulties	DERS-16		X	X	X
Somatic complaints/side effects	Body system questions			X	X	X
Gastrointestinal symptoms	Bristol Stool Scale		X	X	X	X
Self-rating of perceived stress	PSS		X	X	X
Major stressors			X	X	X
Blood pressure, pulse rate, height, weight, waist, hip, medical history, medication evaluation	Assessed by clinician		X	X	X
Physical activity	Actigraphy; mobile health application		X		X
Blood biomarkers	Blood sample		X	X	X
Microbiome	Stool sample		X	X	X
DNA and RNA	Blood sample		X	X	X
Neurocognitive measures	CPT-II		X	X	X
Nutritional intake	Food diary		X	X	X
Treatment adherence/satisfaction/beliefs
Probabilistic Medication Adherence Scale	ProMAS		X	X	X

Abbreviations: ADHD attention-deficit/hyperactivity disorder, ADHD-RS Attention-Deficit/Hyperactivity Disorder Rating Scale, ARI-S Affective Reactivity Index–Self-Report, BPD borderline personality disorder, CGI-I Clinical Global Impression–Improvement Scale, CGI-S Clinical Global Impression–Severity Scale, CPT-II Continuous Performance Test, DERS-16 Difficulties in Emotion Regulation Scale, DIVA 2.0 Diagnostic Interview for Adult ADHD, Second Edition, FAST Functioning Assessment Short Test, IQ intelligence quotient, M.I.N.I.-Plus Mini-International Neuropsychiatric Interview, PROBIA Treatment of impulsivity in adults with probiotics, ProMAS Probabilistic Medication Adherence Scale, PSS Perceived Stress Scale, SCID-II Structured Clinical Interview for DSM-IV Axis II Disorders, SDQ Strengths and Difficulties Questionnaire, SES socioeconomic status, UPPS-P Urgency, Premeditation (lack of), Perseverance (lack of), Sensation Seeking, Positive Urgency, Impulsive Behavior Scale, WAIS Wechsler Adult Intelligence Scale, Y-BOCS Yale-Brown Obsessive Compulsive Scale

ISSN: 1745-6215