Treatment with a probiotic
Dietary SupplementAll 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.
NCT Number: NCT03495375
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.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Universitätsklinikum Frankfurt - Goethe Universität, Frankfurt, Germany
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Assessed at Baseline, at week 5, week 10 and week 11.
Time frame: assessed at weeks 5, 10, and 11.
Time frame: Screnning assessment and again at weeks 1, 5 and 10.
Time frame: Baseline assessment and again at weeks 5, and 10.
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.
assessed by the self-rated multi-dimensional impulsivity (UPPS-P)
Time frame: Baseline assessment and again at weeks 5, and 10.
Time frame: Baseline assessment and again at weeks 5, and 10.
Time frame: Baseline assessment and again at weeks 5, and 10.
5-item questionnaire.
Time frame: assessed at weeks 5, 10, and 11.
Time frame: Baseline assessment and again at weeks 5, and 10.
Change in weight in kilograms
Time frame: Baseline assessment and again at weeks 5, and 10.
Time frame: Baseline assessment and again at weeks 5, and 10.
Time frame: Baseline assessment and again at weeks 5, and 10.
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.
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.
Functioning Assessment Short Test (FAST )
Time frame: Baseline assessment and again at weeks 5, and 10.
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, 10, and 11.
assessed by Bristol Stool Scale;
There are seven types of stool in the Bristol Stool Scale:
Time frame: Baseline assessment and at week 10.
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.
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:
Time frame: Baseline assessment and again at weeks 5 and 10.
assessed by Conners' Continuous Performance Test II (CPTII). Assessment duration: 14min.
Physicological parameter assessed:
Time frame: Baseline assessment and again at weeks 5 and 10.
assessed by Conners' Continuous Performance Test II (CPTII). Assessment duration: 14min.
Physicological parameter assessed:
Time frame: Baseline assessment and again at weeks 5 and 10.
assessed by Conners' Continuous Performance Test II (CPTII). Assessment duration: 14min.
Physicological parameter assessed:
Time frame: Baseline assessment and again at weeks 5 and 10.
assessed by Conners' Continuous Performance Test II (CPTII). Assessment duration: 14min.
Physicological parameter assessed:
Time frame: Baseline assessment and again at weeks 5 and 10.
assessed by Conners' Continuous Performance Test II (CPTII). Assessment duration: 14min.
Physicological parameter assessed:
Time frame: Baseline assessment and again at weeks 5 and 10.
assessed by Conners' Continuous Performance Test II (CPTII). Assessment duration: 14min. .
Physicological parameter assessed:
Time frame: Baseline assessment and again at weeks 5 and 10.
assessed by Conners' Continuous Performance Test II (CPTII). Assessment duration: 14min.
Physicological parameter assessed:
Time frame: Baseline assessment and at week 10.
assessed by Perceived Stress Scale (PSS)
Hospital Vall d'Hebron
Other
Randomized Placebo-controlled Treatment of Impulsivity in Adults With Probiotics
Acronym: PROBIA
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