NCT03495375

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2019

Typical duration for not_applicable

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 12, 2018

Completed
11 months until next milestone

Study Start

First participant enrolled

February 22, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2021

Completed
Last Updated

August 3, 2022

Status Verified

August 1, 2022

Enrollment Period

2.2 years

First QC Date

February 26, 2018

Last Update Submit

August 2, 2022

Conditions

Impulsive BehaviorCompulsive DisorderADHDBorderline Personality Disorder

Keywords

ImpulsivityCompulsivityAggressionMicrobiomeProbioticNutritionPsychiatric disordersSynbiotic2000Forte

Outcome Measures

Primary Outcomes (2)

  • Change in the self-rating of affective reactivity (ARI-S)

    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).

    assessed at weeks 5, 10, and 11.

Secondary Outcomes (25)

  • Change in Clinical Global Impression - Severity (CGI-S)

    Screnning assessment and again at weeks 1, 5 and 10.

  • Change in ADHD symptom severity total score

    Baseline assessment and again at weeks 5, and 10.

  • Change in impulsive behaviour

    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.

  • +20 more secondary outcomes

Study Arms (2)

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.

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.

Other: Treatment with placebo

Interventions

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 a probiotic
Treatment with placeboOTHER

All participants will take the placebo once daily for 10 weeks.

Treatment with placebo powder

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Universitätsklinikum Frankfurt - Goethe Universität

Frankfurt, 60528, Germany

Location

Semmelweis University

Budapest, 1082, Hungary

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Related Publications (3)

  • 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.

    PMID: 38885746DERIVED

  • Stoffers-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.

    PMID: 36375174DERIVED

  • Arteaga-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.

    PMID: 32046750DERIVED

MeSH Terms

Conditions

Impulsive BehaviorCompulsive Personality DisorderAttention Deficit Disorder with HyperactivityBorderline Personality DisorderAggressionMental Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

BehaviorPersonality DisordersAttention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersAberrant Motor Behavior in DementiaBehavioral SymptomsSocial Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department of Psychiatry

Study Record Dates

First Submitted

February 26, 2018

First Posted

April 12, 2018

Study Start

February 22, 2019

Primary Completion

May 20, 2021

Study Completion

May 20, 2021

Last Updated

August 3, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

HU(1)DE(1)ES(1)