Treating Impulsivity in Adults With Probiotics
Condition: Impulsive Behavior; Compulsive Disorder; ADHD; Borderline Personality Disorder
MeSH terms: Personality Disorders; Borderline Personality Disorder; Impulsive Behavior
Study type: Interventional

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.
    

Detailed description: 
      Impulsivity is a cross-disorder trait relevant in several psychiatric disorders, e.g.
      Attention Deficit Hyperactivity Disorder (ADHD) and Borderline Personality Disorder (BPD).
      They place a significant burden on patients, families and society in general. Only adults
      (aged 18 - 65 years) with a diagnosis of ADHD and/or BPD will be included in this study. We
      will also try to include at least 30% female participants to gender-balance the study.

      Recruitment and treatment of participants will be provided at three trial centres: Vall
      d'Hebron Research Institute (VHIR), Goethe University Frankfurt (GU), Semmelweis University
      (SU), each enrolling 60 participants. Randomization to receive either Synbiotic2000Forte or
      placebo will be performed when signed informed assent by the participant has been obtained,
      eligibility checks have been conducted and at baseline assessment. An independent
      randomization service (www.randomization.com) will be used to ensure reliability and
      credibility in the randomization process. The study is double-blinded; neither the
      participants nor the clinicians involved in the study will have access to the randomization
      list.

      In this placebo-controlled 10-week, we will evaluate a probiotic formula for oral
      administration called Synbiotic2000Forte (SF). Participants will take the probiotic once
      daily in the form of a powder that can be spread on top of cold foods such as muesli, salad,
      or yoghurt. Placebo will be a non-digestable carbohydrate with similar texture and flavor to
      the SF. Participants will be assessed at baseline before treatment is started (baseline
      demographics and primary- and secondary outcome measures will be collected and then monitored
      every five weeks for a total of 5 visits.

      Proper conduct of data collection in the trial will be monitored by on-site visits of a
      monitoring staff throughout the study, and quality of data collected will further be
      monitored regularly by a statistical supervision team. Questionnaire data will be collected
      through Castor. All information collected in this study will remain strictly confidential.
      Data of participants will be coded in such a way that participants cannot be identified from
      the corresponding data according to the regulations (unique pseudocode identifier).

      This study will be conducted according to the principles of the Declaration of Helsinki,
      version of 2008 and in accordance with the Medical Research Involving Human Subjects Act
      (WMO, as well as according to the ICH GCP Guideline E6 (1996), EU Directive 2001/20/EC and
      applicable regulatory requirements and guidelines in the participating countries/regions.
      Before the first subject has been enrolled in the trial, all ethical and legal requirements
      were met.
    

Intervention name(s): Treatment with a probiotic; Treatment with placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): All participants will take the probiotic once daily for 10 weeks in the form of a powder that can be spread on top of cold foods such as muesli, salad, or yogurt.; All participants will take the placebo once daily for 10 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Impulsivity; Compulsivity; Aggression; Microbiome; Probiotic; Nutrition; Psychiatric disorders; Synbiotic2000Forte