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Treating Impulsivity in Adults With Probiotics (PROBIA)

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ClinicalTrials.gov Identifier: NCT03495375
Recruitment Status : Not yet recruiting
First Posted : April 12, 2018
Last Update Posted : April 12, 2018
Sponsor:
Collaborators:
University Hospital, Frankfurt
Semmelweis University
University Medical Center Nijmegen
Information provided by (Responsible Party):
Josep Antoni Ramos-Quiroga, Hospital Vall d'Hebron

Brief Summary:
A multicentre randomized double-blind placebo controlled parallel design (10 weeks) and open label (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.

Condition or disease Intervention/treatment Phase
Impulsive Behavior Compulsive Disorder ADHD Borderline Personality Disorder Dietary Supplement: Treatment with a probiotic Other: Treatment with placebo Not Applicable

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 initiation and 10-week open-label, 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Placebo-controlled Treatment of Impulsivity in Adults With Probiotics
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : May 3, 2021
Estimated Study Completion Date : July 26, 2021

Arm Intervention/treatment
Experimental: Treatment with a probiotic
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.
Dietary Supplement: Treatment with a probiotic
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.

Placebo Comparator: Treatment with placebo powder
Placebo will be a non-digestable carbohydrate with similar texture and flavor to the SF also provided by Synbiotic AB, Sweden.
Other: Treatment with placebo
All participants will take the placebo once daily for 10 weeks.




Primary Outcome Measures :
  1. Change in the self-rating of affective reactivity (ARI-S) [ Time Frame: Baseline assessment and again at weeks 10, and 20. ]
  2. Clinical Global Impression - Improvement (CGI-I) total score of 1 or 2 (much improved, very much improved). [ Time Frame: assessed at weeks 5, 10, 15, and 20. ]

Secondary Outcome Measures :
  1. Change in Clinical Global Impression - Severity (CGI-S) [ Time Frame: Baseline assessment and again at weeks 5, 10, 15 and 20. ]
  2. Change in ADHD symptom severity total score [ Time Frame: Baseline assessment and again at weeks 10, and 20. ]
    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.

  3. Change in impulsive behaviour [ Time Frame: Baseline assessment and again at weeks 10, and 20. ]
    assessed by the self-rated multi-dimensional impulsivity (UPPS-P)

  4. Change in Self/other rating of aggression and emotional lability (SDQ) [ Time Frame: Baseline assessment and again at weeks 5, 10, 15 and 20. ]
  5. Change in Clinician rating of compulsivity (Y-BOCS) [ Time Frame: Baseline assessment and again at weeks 10, and 20. ]
  6. Change in sleep problems [ Time Frame: Baseline assessment and again at weeks 10, and 20. ]
    5-item questionnaire.

  7. Change in the somatic complaints and side effects describe by the patient. [ Time Frame: assessed at weeks 5, 10, 15, and 20. ]
  8. Change in body composition parameters [ Time Frame: Baseline assessment and again at weeks 10, and 20. ]
    Change in weight in kilograms

  9. Changes in concentrations of blood biomarkers including hormones, neurotransmitters and nutrients. [ Time Frame: Baseline assessment and again at weeks 10, and 20. ]
  10. Change in microbiome composition [ Time Frame: Baseline assessment and again at weeks 10, and 20. ]
  11. Change in nutritional intake [ Time Frame: Baseline assessment and again at weeks 10, and 20. ]
    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).

  12. Treatment adherence [ Time Frame: Baseline assessment and again at weeks 5, 10, 15 and 20. ]
    Medication Adherence Rating Scale (MARS) is a self-reported measure of medication adherence specifically in psychiatric patients. It is designed to assess both the patients' attitude towards medication and also actual medication-taking behaviour. The MARS contains 10 yes/no item and the sum of items yields a final score ranking from 0 (poor adherence to treatment) to 10 (good adherence to treatment).



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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., 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.

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Responsible Party: Josep Antoni Ramos-Quiroga, Head of Department of Psychiatry, Hospital Vall d'Hebron
ClinicalTrials.gov Identifier: NCT03495375     History of Changes
Other Study ID Numbers: HValldhebron
First Posted: April 12, 2018    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Josep Antoni Ramos-Quiroga, Hospital Vall d'Hebron:
Impulsivity
Compulsivity
Aggression
Microbiome
Probiotic
Nutrition
Psychiatric disorders
Synbiotic2000Forte

Additional relevant MeSH terms:
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Disease
Compulsive Personality Disorder
Personality Disorders
Borderline Personality Disorder
Impulsive Behavior
Pathologic Processes
Mental Disorders