Impulsive BehaviorPROBIANCT03495375
Treating Impulsivity in Adults With Probiotics
A study testing Treatment with a probiotic in people with Impulsive Behavior and Compulsive Disorder, run by Hospital Vall d'Hebron at 3 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Impulsive Behavior, Compulsive Disorder, ADHD
- What is being tested?
- Treatment with a probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 22 Feb 2019to 20 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Germany1 site
Universitätsklinikum Frankfurt - Goethe Universität
Frankfurt, 60528
About this study
Official title: Randomized Placebo-controlled Treatment of Impulsivity in Adults With Probiotics
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.
Read the 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.
- Being tested
- Treatment with a probiotic, Treatment with placebo
- Keywords
- Impulsivity, Compulsivity, Aggression, Microbiome, Probiotic, Nutrition, Psychiatric disorders, Synbiotic2000Forte
- Medical subject headings
- Impulsive Behavior, Compulsive Personality Disorder, Attention Deficit Disorder with Hyperactivity, Borderline Personality Disorder, Aggression, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment with a probioticDietary supplement
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.
Treatment with placeboOther
All participants will take the placebo once daily for 10 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Treatment with a probiotic | Experimental | Synbiotic2000Forte (SF) it is composed of 3 LAB species known to have anti-inflammatory effects and restoring the intestinal barrier, and 4 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, a formula that is currently produced by Synbiotic AB, Sweden. Receives: Dietary Supplement: Treatment with a probiotic |
| Treatment with placebo powder | Placebo comparator | Placebo will be a non-digestable carbohydrate with similar texture and flavor to the SF also provided by Synbiotic AB, Sweden. Receives: Other: Treatment with placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the self-rating of affective reactivity (ARI-S)
Measured: 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).
Measured: assessed at weeks 5, 10, and 11.
Secondary outcomes (25)
Change in Clinical Global Impression - Severity (CGI-S)
Measured: Screnning assessment and again at weeks 1, 5 and 10.
Change in ADHD symptom severity total score
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.
Measured: Baseline assessment and again at weeks 5, and 10.
Change in impulsive behaviour
assessed by the self-rated multi-dimensional impulsivity (UPPS-P)
Measured: Baseline assessment and again at weeks 5, and 10.
Change in Self/other rating of aggression and emotional lability (SDQ)
Measured: Baseline assessment and again at weeks 5, and 10.
Change in Clinician rating of compulsivity (Y-BOCS)
Measured: Baseline assessment and again at weeks 5, and 10.
Change in sleep problems
5-item questionnaire.
Measured: Baseline assessment and again at weeks 5, and 10.
Change in the somatic complaints and side effects describe by the patient.
Measured: assessed at weeks 5, 10, and 11.
Change in body composition parameters
Change in weight in kilograms
Measured: Baseline assessment and again at weeks 5, and 10.
Changes in concentrations of blood biomarkers including hormones, neurotransmitters and nutrients.
Measured: Baseline assessment and again at weeks 5, and 10.
Change in microbiome composition
Measured: Baseline assessment and again at weeks 5, and 10.
Change in nutritional intake
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).
Measured: Baseline assessment and again at weeks 5, and 10.
Treatment adherence
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).
Measured: Baseline assessment and again at weeks 5, and 10.
Change in functioning problems
Functioning Assessment Short Test (FAST )
Measured: Baseline assessment and again at weeks 5, and 10.
Self-rating of emotion regulation difficulties
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).
Measured: Baseline assessment and again at weeks 5, and 10.
Change in gastrointestinal symptoms
assessed by Bristol Stool Scale;
There are seven types of stool in the Bristol Stool Scale:
- Type 1: Separate hard lumps, like nuts (difficult to pass and can be black)
- Type 2: Sausage-shaped, but lumpy
- Type 3: Like a sausage but with cracks on its surface (can be black)
- Type 4: Like a sausage or snake, smooth and soft (average stool)
- Type 5: Soft blobs with clear cut edges
- Type 6: Fluffy pieces with ragged edges, a mushy stool (diarrhoea)
- Type 7: Watery, no solid pieces, entirely liquid (diarrhoea) Types 1 and 2 indicate constipation, with 3 and 4 being the ideal stools as they are easy to defecate while not containing excess liquid, 5 indicating lack of dietary fiber, and 6 and 7 indicate diarrhoea.
Measured: Baseline assessment and again at weeks 5, 10, and 11.
Change in physical activity: Duration of the activity
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).
Measured: Baseline assessment and at week 10.
Change in physical activity: Intensity of the activity
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:
- sedentary
- light
- moderate
- vigorous
Measured: Baseline assessment and at week 10.
Change in neurocognitive measure: Detectability
assessed by Conners' Continuous Performance Test II (CPTII). Assessment duration: 14min.
Physicological parameter assessed:
- Detectability (d'): this is a measure of how well the respondent discriminates non-targets (i.e. the letter X) from targets (i.e. all the other letters). This variable is also a signal detection statistic that measures the difference between the signal (targets) and noise (non-targets) distributions. On the Conners CPT-II, d' is reverse scored so that higher raw score and T-score values indicate worse performance (i.e. poorer discrimination)
Measured: Baseline assessment and again at weeks 5 and 10.
Change in neurocognitive measure: Omissions
assessed by Conners' Continuous Performance Test II (CPTII). Assessment duration: 14min.
Physicological parameter assessed:
- Omissions (%): Omissions are missed targets. High omissions error rates indicate that the respondent was not responding to the target stimuli due to a specific reason (e.g. difficulty focusing). Omission errors are generally an indicator of inattentiveness.
Measured: Baseline assessment and again at weeks 5 and 10.
Change in neurocognitive measure: Commissions
assessed by Conners' Continuous Performance Test II (CPTII). Assessment duration: 14min.
Physicological parameter assessed:
- Commissions (%): Commissions are incorrect responses to non-targets. Depending on the respondent's HRT, high commission error rates may indicate either inattentiveness or impulsivity. If high commission error rates are coupled with slow reaction times, then the respondent was likely inattentive to the stimulus type being presented and thus responded to a high rate of non-targets. If high commission error rates are combined with fast reaction times, the respondent was likely rushing to respond and failed to control his or her impulses when responding to the non-targets. In the latter case, high commission error rates would reflect impulsivity rather than inattentiveness.
Measured: Baseline assessment and again at weeks 5 and 10.
Change in neurocognitive measure: Perseverations
assessed by Conners' Continuous Performance Test II (CPTII). Assessment duration: 14min.
Physicological parameter assessed:
- Perseverations (%): Perseverations are responses that are made in less than 100 milliseconds following the presentation of a stimulus. Normal expectations of physiological ability to respond make it virtually impossible for a respondent to perceive and react to a stimulus so quickly. Perseverations are unusually either slow responses to a preceding stimulus, a random response, an anticipatory response, or a repeated response without consideration of the task requirements. Perseverations may be related to impulsivity or an extremely liberal response style. Perseverations are, therefore, likely the result of anticipatory, repetitive, or impulsive responding.
Measured: Baseline assessment and again at weeks 5 and 10.
Change in neurocognitive measure: Hit Reaction Time (HRT)
assessed by Conners' Continuous Performance Test II (CPTII). Assessment duration: 14min.
Physicological parameter assessed:
- Hit Reaction Time (HRT): HRT is the mean response speed, measured in milliseconds, for all non-perseverative responses made during the entire administration. An atypically slow HRT may indicate inattentiveness (especially when error rates are high), but it may also be the results of a very conservative response style. Alternatively, a very fast HRT, when combined with high commission error rates, may indicate impulsivity.
Measured: Baseline assessment and again at weeks 5 and 10.
Change in neurocognitive measure: Hit Reaction Time Standard Deviation (HRT SD)
assessed by Conners' Continuous Performance Test II (CPTII). Assessment duration: 14min. .
Physicological parameter assessed:
- Hit Reaction Time Standard Deviation (HRT SD): HRT SD measures the consistency of response speed to targets for the entire administration. A high HRT SD indicates greater inconsistency in response speed. Response speed inconsistency is sometimes indicative of an inattentiveness, suggesting that the respondent was less engaged and processed stimuli less efficiently during some parts of the administration.
Measured: Baseline assessment and again at weeks 5 and 10.
Change in neurocognitive measure: Variability
assessed by Conners' Continuous Performance Test II (CPTII). Assessment duration: 14min.
Physicological parameter assessed:
- Variability: Variability, like HRT SD, is a measure of response speed consistency, however, Variability is a "within respondent" measure (i.e. the amount of variability the respondent showed in 18 separate sub-blocks of the administration in relation to his or her overall HRT SD score). Although Variability is a different measure than HRT SD, the two measures typically produce comparable results and are both related to inattentiveness. High response speed variability indicates that the respondent's attention and processing efficiency varied throughout the administration.
Measured: 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).
assessed by Perceived Stress Scale (PSS)
Measured: Baseline assessment and at week 10.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2018
- Study start22 Feb 2019
- Primary completion20 May 2021
- Study completion20 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Impulsive BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Vall d'Hebron
- Sponsor type
- University, hospital or other
- Collaborators
- Goethe University, Semmelweis University, University Medical Center Nijmegen
- Responsible party
- Principal investigator, Josep Antoni Ramos-Quiroga, Hospital Vall d'Hebron
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03495375
- Sponsor's protocol ID
- HValldhebron
- Acronym
- PROBIA
- Status last verified
- Aug 2022
- First submitted
- 26 Feb 2018
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Arteaga-Henriquez G, Ramos-Sayalero C, Ibanez-Jimenez P, Karina Rosales-Ortiz S, Kilencz T, Schiweck C, Schnorr I, Siegl A, Arias-Vasquez A, Bitter I, Fadeuilhe C, Ferrer M, Lavebratt C, Matura S, Reif A, Rethelyi JM, Richarte V, Rommelse N, Antoni Ramos-Quiroga J. Efficacy of a synbiotic in the management of adults with Attention-Deficit and Hyperactivity Disorder and/or Borderline Personality Disorder and high levels of irritability: Results from a multicenter, randomized, placebo-controlled, "basket" trial. Brain Behav Immun. 2024 Aug;120:360-371. doi: 10.1016/j.bbi.2024.06.012. Epub 2024 Jun 15.
PubMed 38885746Stoffers-Winterling JM, Storebo OJ, Pereira Ribeiro J, Kongerslev MT, Vollm BA, Mattivi JT, Faltinsen E, Todorovac A, Jorgensen MS, Callesen HE, Sales CP, Schaug JP, Simonsen E, Lieb K. Pharmacological interventions for people with borderline personality disorder. Cochrane Database Syst Rev. 2022 Nov 14;11(11):CD012956. doi: 10.1002/14651858.CD012956.pub2.
PubMed 36375174Arteaga-Henriquez G, Rosales-Ortiz SK, Arias-Vasquez A, Bitter I, Ginsberg Y, Ibanez-Jimenez P, Kilencz T, Lavebratt C, Matura S, Reif A, Rethelyi J, Richarte V, Rommelse N, Siegl A, Ramos-Quiroga JA. Treating impulsivity with probiotics in adults (PROBIA): study protocol of a multicenter, double-blind, randomized, placebo-controlled trial. Trials. 2020 Feb 11;21(1):161. doi: 10.1186/s13063-019-4040-x.
PubMed 32046750
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Placebo-controlled Treatment of Impulsivity in Adults With Probiotics
- ClinicalTrials.gov ID
- NCT03495375
- Acronym / sponsor ID
- PROBIA / HValldhebron
- Keywords
- Impulsivity, Compulsivity, Aggression, Microbiome, Probiotic, Nutrition, Psychiatric disorders, Synbiotic2000Forte
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Hospital Vall d'HebronUniversity, hospital or other
- Collaborators
- Goethe University, Semmelweis University, University Medical Center Nijmegen
- Study start
- 22 Feb 2019 (actual)
- Primary completion
- 20 May 2021 (actual)
- Study completion
- 20 May 2021 (actual)
- First posted
- 12 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment with a probiotic | Experimental | Dietary Supplement: Treatment with a probioticSynbiotic2000Forte (SF) it is composed of 3 LAB species known to have anti-inflammatory effects and restoring the intestinal barrier, and 4 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, a formula that is currently produced by Synbiotic AB, Sweden. |
| Treatment with placebo powder | Placebo comparator | Other: Treatment with placeboPlacebo will be a non-digestable carbohydrate with similar texture and flavor to the SF also provided by Synbiotic AB, Sweden. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment with a probioticAll 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. | Dietary supplement | Treatment with a probiotic |
| Treatment with placeboAll participants will take the placebo once daily for 10 weeks. | Other | Treatment with placebo powder |
Primary outcome
Change in the self-rating of affective reactivity (ARI-S)
Time frame: 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).
Time frame: assessed at weeks 5, 10, and 11.
25 secondary outcomes
Change in Clinical Global Impression - Severity (CGI-S)
Time frame: Screnning assessment and again at weeks 1, 5 and 10.
Change in ADHD symptom severity total score
Time frame: Baseline assessment and again at weeks 5, and 10.
Change in impulsive behaviour
Time frame: Baseline assessment and again at weeks 5, and 10.
Change in Self/other rating of aggression and emotional lability (SDQ)
Time frame: Baseline assessment and again at weeks 5, and 10.
Change in Clinician rating of compulsivity (Y-BOCS)
Time frame: Baseline assessment and again at weeks 5, and 10.
Change in sleep problems
Time frame: Baseline assessment and again at weeks 5, and 10.
Change in the somatic complaints and side effects describe by the patient.
Time frame: assessed at weeks 5, 10, and 11.
Change in body composition parameters
Time frame: Baseline assessment and again at weeks 5, and 10.
Changes in concentrations of blood biomarkers including hormones, neurotransmitters and nutrients.
Time frame: Baseline assessment and again at weeks 5, and 10.
Change in microbiome composition
Time frame: Baseline assessment and again at weeks 5, and 10.
Change in nutritional intake
Time frame: Baseline assessment and again at weeks 5, and 10.
Treatment adherence
Time frame: Baseline assessment and again at weeks 5, and 10.
Change in functioning problems
Time frame: Baseline assessment and again at weeks 5, and 10.
Self-rating of emotion regulation difficulties
Time frame: Baseline assessment and again at weeks 5, and 10.
Change in gastrointestinal symptoms
Time frame: Baseline assessment and again at weeks 5, 10, and 11.
Change in physical activity: Duration of the activity
Time frame: Baseline assessment and at week 10.
Change in physical activity: Intensity of the activity
Time frame: Baseline assessment and at week 10.
Change in neurocognitive measure: Detectability
Time frame: Baseline assessment and again at weeks 5 and 10.
Change in neurocognitive measure: Omissions
Time frame: Baseline assessment and again at weeks 5 and 10.
Change in neurocognitive measure: Commissions
Time frame: Baseline assessment and again at weeks 5 and 10.
Change in neurocognitive measure: Perseverations
Time frame: Baseline assessment and again at weeks 5 and 10.
Change in neurocognitive measure: Hit Reaction Time (HRT)
Time frame: Baseline assessment and again at weeks 5 and 10.
Change in neurocognitive measure: Hit Reaction Time Standard Deviation (HRT SD)
Time frame: Baseline assessment and again at weeks 5 and 10.
Change in neurocognitive measure: Variability
Time frame: 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).
Time frame: Baseline assessment and at week 10.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
- Derived from this study: PubMed 38885746Arteaga-Henriquez G, Ramos-Sayalero C, Ibanez-Jimenez P, Karina Rosales-Ortiz S, Kilencz T, Schiweck C, Schnorr I, Siegl A, Arias-Vasquez A, Bitter I, Fadeuilhe C, Ferrer M, Lavebratt C, Matura S, Reif A, Rethelyi JM, Richarte V, Rommelse N, Antoni Ramos-Quiroga J. Efficacy of a synbiotic in the management of adults with Attention-Deficit and Hyperactivity Disorder and/or Borderline Personality Disorder and high levels of irritability: Results from a multicenter, randomized, placebo-controlled, "basket" trial. Brain Behav Immun. 2024 Aug;120:360-371. doi: 10.1016/j.bbi.2024.06.012. Epub 2024 Jun 15.
- Derived from this study: PubMed 36375174Stoffers-Winterling JM, Storebo OJ, Pereira Ribeiro J, Kongerslev MT, Vollm BA, Mattivi JT, Faltinsen E, Todorovac A, Jorgensen MS, Callesen HE, Sales CP, Schaug JP, Simonsen E, Lieb K. Pharmacological interventions for people with borderline personality disorder. Cochrane Database Syst Rev. 2022 Nov 14;11(11):CD012956. doi: 10.1002/14651858.CD012956.pub2.
- Derived from this study: PubMed 32046750Arteaga-Henriquez G, Rosales-Ortiz SK, Arias-Vasquez A, Bitter I, Ginsberg Y, Ibanez-Jimenez P, Kilencz T, Lavebratt C, Matura S, Reif A, Rethelyi J, Richarte V, Rommelse N, Siegl A, Ramos-Quiroga JA. Treating impulsivity with probiotics in adults (PROBIA): study protocol of a multicenter, double-blind, randomized, placebo-controlled trial. Trials. 2020 Feb 11;21(1):161. doi: 10.1186/s13063-019-4040-x.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment with a probiotic in people with Impulsive Behavior and Compulsive Disorder, run by Hospital Vall d'Hebron at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, Hungary, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the self-rating of affective reactivity (ARI-S) (time frame: Assessed at Baseline, at week 5, week 10 and week 11.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03495375, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2022.