Randomized Placebo-controlled Treatment of Impulsivity in Adults With Probiotics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 6
- 主要终点
- Change in the self-rating of affective reactivity (ARI-S)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults with a high level of impulsivity (with or without ADHD) based on a CGI-S-score ≥
- •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.
排除标准
- •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.
结局指标
主要结局
Change in the self-rating of affective reactivity (ARI-S)
时间窗: Assessed at Baseline, at week 5, week 10 and week 11.
Clinical Global Impression - Improvement (CGI-I) total score of 1 or 2 (much improved, very much improved).
时间窗: assessed at weeks 5, 10, and 11.
次要结局
- Change in Clinical Global Impression - Severity (CGI-S)(Screnning assessment and again at weeks 1, 5 and 10.)
- Change in sleep problems(Baseline assessment and again at weeks 5, and 10.)
- Change in ADHD symptom severity total score(Baseline assessment and again at weeks 5, and 10.)
- Change in neurocognitive measure: Commissions(Baseline assessment and again at weeks 5 and 10.)
- Change in impulsive behaviour(Baseline assessment and again at weeks 5, and 10.)
- Change in body composition parameters(Baseline assessment and again at weeks 5, and 10.)
- Changes in concentrations of blood biomarkers including hormones, neurotransmitters and nutrients.(Baseline assessment and again at weeks 5, and 10.)
- Change in microbiome composition(Baseline assessment and again at weeks 5, and 10.)
- Change in nutritional intake(Baseline assessment and again at weeks 5, and 10.)
- Self-rating of emotion regulation difficulties(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).(Baseline assessment and at week 10.)
- Change in functioning problems(Baseline assessment and again at weeks 5, and 10.)
- Change in Self/other rating of aggression and emotional lability (SDQ)(Baseline assessment and again at weeks 5, and 10.)
- Change in Clinician rating of compulsivity (Y-BOCS)(Baseline assessment and again at weeks 5, and 10.)
- Change in the somatic complaints and side effects describe by the patient.(assessed at weeks 5, 10, and 11.)
- Change in physical activity: Intensity of the activity(Baseline assessment and at week 10.)
- Change in neurocognitive measure: Detectability(Baseline assessment and again at weeks 5 and 10.)
- Change in neurocognitive measure: Hit Reaction Time Standard Deviation (HRT SD)(Baseline assessment and again at weeks 5 and 10.)
- Treatment adherence(Baseline assessment and again at weeks 5, and 10.)
- Change in gastrointestinal symptoms(Baseline assessment and again at weeks 5, 10, and 11.)
- Change in physical activity: Duration of the activity(Baseline assessment and at week 10.)
- Change in neurocognitive measure: Omissions(Baseline assessment and again at weeks 5 and 10.)
- Change in neurocognitive measure: Perseverations(Baseline assessment and again at weeks 5 and 10.)
- Change in neurocognitive measure: Hit Reaction Time (HRT)(Baseline assessment and again at weeks 5 and 10.)
- Change in neurocognitive measure: Variability(Baseline assessment and again at weeks 5 and 10.)
研究者
Josep Antoni Ramos-Quiroga
Head of Department of Psychiatry
Hospital Vall d'Hebron