Please select the eligibility criteria that correspond to the clinical trial below.
Title: Randomized Placebo-controlled Treatment of Impulsivity in Adults With Probiotics
Brief Summary: A multicentre randomized double-blind placebo controlled parallel design (10 weeks) study investigating probiotic supplementation in highly impulsive adults (18-65 yrs; N=180). The probiotic studied is Synbiotic2000Forte that contain three well-studied anti-inflammatory lactic acid bacteria (LABs) and four fermentable fibers: Pediococcus pentosaceus 5-33:3, Lactobacillus paracasei subsp paracasei 19, and Lactobacillus plantarum 2362 in combination with the following four fermentable fibres: betaglucan, inulin, pectin and resistant starch. With this study we aim to detect, whether treatment with probiotics is effective in adults with high levels of impulsivity, compulsivity, and aggression.


Options:
A: Inclusion Criteria:

* Adults with a high level of impulsivity (with or without ADHD) based on a CGI-S-score ≥ 4.
* An Affective Reactivity Index (ARI) score ≥5 indicating a high level of multi dimensional impulsivity.
* Research diagnosis of attention-deficit/hyperactivity disorder (ADHD) and/or borderline personality disorder (BPD) confirmed by structured diagnostic interview according to DSM-5 (ADHD: Diagnostic Interview for Adult ADHD (DIVA 2.0); BPD: Structured Clinical Interview for DSM-IV (SCID-II)).
* Not currently taking any antibiotics or probiotics.
* 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.

Exclusion Criteria:

* Subject is being treated with a concomitant medication which is prohibited within this study according to the list of prohibited medications.
* Patients must be on stable medication (i.e. current dose is given since more than 30 days): up-titration is not allowed and careful clinical screening is done at all visits to check whether lower dosage is needed due to increased side effects as a result of treatment with Synbiotic2000Forte.
* Presence of major psychiatric disorders with psychotic's symptoms.
* Neurological disorder involving brain or other central function (e.g., intellectual disability with an assessed IQ \< 70, epilepsy, MS, narcolepsy) or other major psychiatric condition requiring hospitalization (e.g., significant mood disorder or psychosis).
* Major physical illness of the cardiovascular, endocrine, pulmonal, or the gastrointestinal system.
* History of or present clinically relevant somatic acute or chronic disorder that, in the opinion of the investigator, might confound the results of tolerability/safety assessment, or prohibit the patients from completing the study, or would not be in the best interest of the patient.
* Subject has a 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.
B: Inclusion Criteria:

* Attempted suicide
* At least 12 years old

Exclusion Criteria:

* Psychotic disorder
* Severe dementia
* Institutionalised or hospitalised for more than 2 weeks at psychiatric department
C: Inclusion Criteria:

* Age 16 - 25 years old
* Have adequate English language ability to permit the assessment and experimental measures to be completed and use of the smartphone app
* Presented with at least 2 episodes of self-harm (defined in 2.2) over the last three months
* Willing to receive support to reduce / improve management of self-harm urges and behaviour in person, over the phone and via Android smartphone app (own or made available by researchers\*)
* Willing to have letters sent/phone calls made to their General Practitioner (GP) and other relevant clinicians
* Can commit to attending 2 consecutive weekly sessions, and 5 fortnightly phone follow-up sessions, and assessments over follow up period as required by the study
* Resident within geographical areas covered by the Cambridgeshire and Peterborough NHS Foundation trust (CPFT)
* Able to give consent

Exclusion Criteria:

* Experiencing current severe psychopathology that is of impediment to completing the study requirements, e.g. active psychotic symptoms (clinicians assessment)
* Currently treated under the care of the CPFT Personality Disorders Pathway
* Currently under the care of the CPFT Crisis Resolution and Home Treatment Team or under inpatient care
* Learning difficulties, organic brain disease, severe neurological impairment
* Current severe substance or alcohol abuse (clinicians assessment)
* Presence of active suicidal risk on the Mini International Neuropsychiatric Interview (MINI) confirmed by convergent clinical opinion (see risk assessment protocol, Appendix 1)
* Unwilling to engage actively in the Functional Imagery Training (FIT) intervention or to use an imagery-focused approach for treatment
* Unwilling to use a smartphone app
* Taking part in concurrent treatment studies investigating pharmacological or psychological treatment for self-harm
D: Inclusion Criteria:

* All patients 18 years and over, presenting to the ED with self-harm.
* All patients should have a mobile phone, be familiar with text messaging technology and be willing to take part in the study.

Exclusion Criteria:

* Patients who do not consent to take part in the study.
* Patients who do not have a mobile phone or are unable to use the mobile text message technology.
* Patients who are admitted as a psychiatric inpatient following the assessment in the ED or those who require admission to a medical ward for longer than 48 hours.
* Patients who would be unavailable for follow-up during the study period.

Answer: A