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Treating Impulsivity in Adults With Probiotics

NCT03495375 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2022-08-03

No results posted yet for this study

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.

Conditions

  • Impulsive Behavior
  • Compulsive Disorder
  • ADHD
  • Borderline Personality Disorder

Interventions

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.

OTHER

Treatment with placebo

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

Sponsors & Collaborators

  • Goethe University

    collaborator OTHER

  • Semmelweis University

    collaborator OTHER

  • University Medical Center Nijmegen

    collaborator OTHER

  • Hospital Vall d'Hebron

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-22
Primary Completion
2021-05-20
Completion
2021-05-20

Countries

  • Germany
  • Hungary
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03495375 on ClinicalTrials.gov