Treating Impulsivity in Adults With Probiotics

Change in Clinical Global Impression - Severity (CGI-S)

Time frame: Screnning assessment and again at weeks 1, 5 and 10.

Change in ADHD symptom severity total score

assessed by the Adult Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS). The ADHD-RS is a 18-items scale self-report version for assessing symptoms for ADHD DSM-IV. It consists of a subscale of inattention (IN, 9-items), another of hyperactivity/impulsivity (H / I, 9-items) and the total (TOT, 18-items). The interviewees are asked about the frequency of the symptoms over the past 6 months. Each item is scored from 0 to 3 points, and the highest scores indicates more severe symptomatology of ADHD.

Time frame: Baseline assessment and again at weeks 5, and 10.

Change in impulsive behaviour

assessed by the self-rated multi-dimensional impulsivity (UPPS-P)

Time frame: Baseline assessment and again at weeks 5, and 10.

Change in Self/other rating of aggression and emotional lability (SDQ)

Time frame: Baseline assessment and again at weeks 5, and 10.

Change in Clinician rating of compulsivity (Y-BOCS)

Time frame: Baseline assessment and again at weeks 5, and 10.

Change in sleep problems

5-item questionnaire.

Time frame: Baseline assessment and again at weeks 5, and 10.

Change in the somatic complaints and side effects describe by the patient.

Time frame: assessed at weeks 5, 10, and 11.

Change in body composition parameters

Change in weight in kilograms

Time frame: Baseline assessment and again at weeks 5, and 10.

Changes in concentrations of blood biomarkers including hormones, neurotransmitters and nutrients.

Time frame: Baseline assessment and again at weeks 5, and 10.

Change in microbiome composition

Time frame: Baseline assessment and again at weeks 5, and 10.

Change in nutritional intake

Participants will be asked to complete at least three 24-h dietary recall (24HDR) per visit, including two week days and one weekend day (non-consecutive days).

Time frame: Baseline assessment and again at weeks 5, and 10.

Treatment adherence

Probabilistic Medication Adherence Scale (ProMAS); The total score ranges from 0-18 with a higher score indicating better adherence. Each item is scored as yes (1) or No (0).

Time frame: Baseline assessment and again at weeks 5, and 10.

Change in functioning problems

Functioning Assessment Short Test (FAST )

Time frame: Baseline assessment and again at weeks 5, and 10.

Self-rating of emotion regulation difficulties

assessed by Difficulties in Emotion Regulation Scale (DERS-16). The total score ranges from 16-80 with a higher score indicating higher difficulties in emotion regulation. Each item is scored as Almost never (1), Somtimes (2), About half the time (3), Most of the time (4), Almost always (5).

Time frame: Baseline assessment and again at weeks 5, and 10.

Change in gastrointestinal symptoms

assessed by Bristol Stool Scale; There are seven types of stool in the Bristol Stool Scale: * Type 1: Separate hard lumps, like nuts (difficult to pass and can be black) * Type 2: Sausage-shaped, but lumpy * Type 3: Like a sausage but with cracks on its surface (can be black) * Type 4: Like a sausage or snake, smooth and soft (average stool) * Type 5: Soft blobs with clear cut edges * Type 6: Fluffy pieces with ragged edges, a mushy stool (diarrhoea) * Type 7: Watery, no solid pieces, entirely liquid (diarrhoea) Types 1 and 2 indicate constipation, with 3 and 4 being the ideal stools as they are easy to defecate while not containing excess liquid, 5 indicating lack of dietary fiber, and 6 and 7 indicate diarrhoea.

Time frame: Baseline assessment and again at weeks 5, 10, and 11.

Change in physical activity: Duration of the activity

parameter measured with a movement sensor.The actigraphy records the duration of the activity. The activity report outcomes how long the participant move (days/hours/min).

Time frame: Baseline assessment and at week 10.

Change in physical activity: Intensity of the activity

parameter measured with a movement sensor. The actigraphy records the intensity of the activity. The report of activity outcomes the intensity of the movement classified in four categories from lowest intensity to highest intensity; these categories are: * sedentary * light * moderate * vigorous

Time frame: Baseline assessment and at week 10.

Change in neurocognitive measure: Detectability

assessed by Conners' Continuous Performance Test II (CPTII). Assessment duration: 14min. Physicological parameter assessed: \- Detectability (d'): this is a measure of how well the respondent discriminates non-targets (i.e. the letter X) from targets (i.e. all the other letters). This variable is also a signal detection statistic that measures the difference between the signal (targets) and noise (non-targets) distributions. On the Conners CPT-II, d' is reverse scored so that higher raw score and T-score values indicate worse performance (i.e. poorer discrimination)

Time frame: Baseline assessment and again at weeks 5 and 10.

Change in neurocognitive measure: Omissions

assessed by Conners' Continuous Performance Test II (CPTII). Assessment duration: 14min. Physicological parameter assessed: \- Omissions (%): Omissions are missed targets. High omissions error rates indicate that the respondent was not responding to the target stimuli due to a specific reason (e.g. difficulty focusing). Omission errors are generally an indicator of inattentiveness.

Time frame: Baseline assessment and again at weeks 5 and 10.

Change in neurocognitive measure: Commissions

assessed by Conners' Continuous Performance Test II (CPTII). Assessment duration: 14min. Physicological parameter assessed: \- Commissions (%): Commissions are incorrect responses to non-targets. Depending on the respondent's HRT, high commission error rates may indicate either inattentiveness or impulsivity. If high commission error rates are coupled with slow reaction times, then the respondent was likely inattentive to the stimulus type being presented and thus responded to a high rate of non-targets. If high commission error rates are combined with fast reaction times, the respondent was likely rushing to respond and failed to control his or her impulses when responding to the non-targets. In the latter case, high commission error rates would reflect impulsivity rather than inattentiveness.

Time frame: Baseline assessment and again at weeks 5 and 10.

Change in neurocognitive measure: Perseverations

assessed by Conners' Continuous Performance Test II (CPTII). Assessment duration: 14min. Physicological parameter assessed: \- Perseverations (%): Perseverations are responses that are made in less than 100 milliseconds following the presentation of a stimulus. Normal expectations of physiological ability to respond make it virtually impossible for a respondent to perceive and react to a stimulus so quickly. Perseverations are unusually either slow responses to a preceding stimulus, a random response, an anticipatory response, or a repeated response without consideration of the task requirements. Perseverations may be related to impulsivity or an extremely liberal response style. Perseverations are, therefore, likely the result of anticipatory, repetitive, or impulsive responding.

Time frame: Baseline assessment and again at weeks 5 and 10.

Change in neurocognitive measure: Hit Reaction Time (HRT)

assessed by Conners' Continuous Performance Test II (CPTII). Assessment duration: 14min. Physicological parameter assessed: \- Hit Reaction Time (HRT): HRT is the mean response speed, measured in milliseconds, for all non-perseverative responses made during the entire administration. An atypically slow HRT may indicate inattentiveness (especially when error rates are high), but it may also be the results of a very conservative response style. Alternatively, a very fast HRT, when combined with high commission error rates, may indicate impulsivity.

Time frame: Baseline assessment and again at weeks 5 and 10.

Change in neurocognitive measure: Hit Reaction Time Standard Deviation (HRT SD)

assessed by Conners' Continuous Performance Test II (CPTII). Assessment duration: 14min. . Physicological parameter assessed: \- Hit Reaction Time Standard Deviation (HRT SD): HRT SD measures the consistency of response speed to targets for the entire administration. A high HRT SD indicates greater inconsistency in response speed. Response speed inconsistency is sometimes indicative of an inattentiveness, suggesting that the respondent was less engaged and processed stimuli less efficiently during some parts of the administration.

Time frame: Baseline assessment and again at weeks 5 and 10.

Change in neurocognitive measure: Variability

assessed by Conners' Continuous Performance Test II (CPTII). Assessment duration: 14min. Physicological parameter assessed: \- Variability: Variability, like HRT SD, is a measure of response speed consistency, however, Variability is a "within respondent" measure (i.e. the amount of variability the respondent showed in 18 separate sub-blocks of the administration in relation to his or her overall HRT SD score). Although Variability is a different measure than HRT SD, the two measures typically produce comparable results and are both related to inattentiveness. High response speed variability indicates that the respondent's attention and processing efficiency varied throughout the administration.

Time frame: Baseline assessment and again at weeks 5 and 10.

Change in self-rating of perceived stress. The total score ranges from 0-40 with a higher score indicating higher perceived stress. Each item is scored as Never (0), Almost never (1), Sometimes (2), Fairly Often (3), Very Often (4).

assessed by Perceived Stress Scale (PSS)

Time frame: Baseline assessment and at week 10.