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.
Who can participate
Age range18 Years – 65 Years
SexALL
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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., signif…
What they're measuring
1
Change in the self-rating of affective reactivity (ARI-S)
Timeframe: Assessed at Baseline, at week 5, week 10 and week 11.
2
Clinical Global Impression - Improvement (CGI-I) total score of 1 or 2 (much improved, very much improved).