Treating impulsivity with probiotics in adults (PROBIA): study protocol of a multicenter, double-blind, randomized, placebo-controlled trial
Abstract Background Impulsivity and compulsivity are related to emotional and social maladjustment and often underlie psychiatric disorders. Recently, alterations in microbiota composition have been shown to have implications for brain development and social behavior via the microbiota–gut–brain axi...
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| Format: | Article |
| Language: | English |
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BMC
2020-02-01
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| Series: | Trials |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13063-019-4040-x |
| _version_ | 1818410468879892480 |
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| author | Gara Arteaga-Henríquez Silvia Karina Rosales-Ortiz Alejandro Arias-Vásquez Istvan Bitter Ylva Ginsberg Pol Ibañez-Jimenez Tünde Kilencz Catharina Lavebratt Silke Matura Andreas Reif Janos Rethelyi Vanesa Richarte Nanda Rommelse Anne Siegl J. Antoni Ramos-Quiroga |
| author_facet | Gara Arteaga-Henríquez Silvia Karina Rosales-Ortiz Alejandro Arias-Vásquez Istvan Bitter Ylva Ginsberg Pol Ibañez-Jimenez Tünde Kilencz Catharina Lavebratt Silke Matura Andreas Reif Janos Rethelyi Vanesa Richarte Nanda Rommelse Anne Siegl J. Antoni Ramos-Quiroga |
| author_sort | Gara Arteaga-Henríquez |
| collection | DOAJ |
| description | Abstract Background Impulsivity and compulsivity are related to emotional and social maladjustment and often underlie psychiatric disorders. Recently, alterations in microbiota composition have been shown to have implications for brain development and social behavior via the microbiota–gut–brain axis. However, the exact mechanisms are not fully identified. Recent evidence suggests the modulatory effect of synbiotics on gut microbiota and the contribution of these agents in ameliorating symptoms of many psychiatric diseases. To date, no randomized controlled trial has been performed to establish the feasibility and efficacy of this intervention targeting the reduction of impulsivity and compulsivity. We hypothesize that supplementation with synbiotics may be an effective treatment in adults with high levels of impulsivity and/or compulsivity. Methods/design This is a prospective, multicenter, double-blind, randomized controlled trial with two arms: treatment with a synbiotic formula versus placebo treatment. The primary outcome is the response rate at the end of the placebo-controlled phase (response defined as a Clinical Global Impression–Improvement Scale score of 1 or 2 = very much improved or much improved, plus a reduction in the Affective Reactivity Index total score of at least 30% compared with baseline). A total of 180 participants with highly impulsive behavior and a diagnosis of attention deficit/hyperactivity disorder (ADHD) and/or borderline personality disorder, aged 18–65 years old, will be screened at three study centers. Secondary outcome measures, including changes in general psychopathology, ADHD symptoms, neurocognitive function, somatic parameters, physical activity, nutritional intake, and health-related quality of life, will be explored at assessments before, during, and at the end of the intervention. The effect of the intervention on genetics, microbiota, and several blood biomarkers will also be assessed. Gastrointestinal symptoms and somatic complaints will additionally be explored at 1-week follow-up. Discussion This is the first randomized controlled trial to determine the effects of supplementation with synbiotics on reducing impulsive and compulsive behavior. This clinical trial can contribute to explaining the mechanisms involved in the crosstalk between the intestinal microbiome and the brain. If effects can be established by reducing impulsive and compulsive behavior, new cost-effective treatments might become available to these patients. Trial registration ClinicalTrials.gov, NCT03495375 . Registered on 26 February 2018. |
| first_indexed | 2024-12-14T10:16:00Z |
| format | Article |
| id | doaj.art-c4ac6e442a014737af669a81f5c6a978 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-14T10:16:00Z |
| publishDate | 2020-02-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-c4ac6e442a014737af669a81f5c6a9782022-12-21T23:06:50ZengBMCTrials1745-62152020-02-0121111210.1186/s13063-019-4040-xTreating impulsivity with probiotics in adults (PROBIA): study protocol of a multicenter, double-blind, randomized, placebo-controlled trialGara Arteaga-Henríquez0Silvia Karina Rosales-Ortiz1Alejandro Arias-Vásquez2Istvan Bitter3Ylva Ginsberg4Pol Ibañez-Jimenez5Tünde Kilencz6Catharina Lavebratt7Silke Matura8Andreas Reif9Janos Rethelyi10Vanesa Richarte11Nanda Rommelse12Anne Siegl13J. Antoni Ramos-Quiroga14Department of Psychiatry, Hospital Universitari Vall d’HebronDepartment of Psychiatry, Hospital Universitari Vall d’HebronDepartment of Human Genetics, Donders Institute for Brain, Cognition and Behavior, Radboud University Medical CentreDepartment of Psychiatry and Psychotherapy, Semmelweis UniversityDepartment of Clinical Neuroscience, Centre for Psychiatry Research, Karolinska InstituteDepartment of Psychiatry, Hospital Universitari Vall d’HebronDepartment of Psychiatry and Psychotherapy, Semmelweis UniversityDepartment of Molecular Medicine and Surgery, Karolinska InstituteDepartment of Psychiatry, Psychosomatic Medicine and Psychotherapy, University Hospital, Goethe UniversityDepartment of Psychiatry, Psychosomatic Medicine and Psychotherapy, University Hospital, Goethe UniversityDepartment of Psychiatry and Psychotherapy, Semmelweis UniversityDepartment of Psychiatry, Hospital Universitari Vall d’HebronDepartment of Psychiatry, Donders Institute for Brain, Cognition and Behavior, Radboud University Medical CentreDepartment of Psychiatry, Psychosomatic Medicine and Psychotherapy, University Hospital, Goethe UniversityDepartment of Psychiatry, Hospital Universitari Vall d’HebronAbstract Background Impulsivity and compulsivity are related to emotional and social maladjustment and often underlie psychiatric disorders. Recently, alterations in microbiota composition have been shown to have implications for brain development and social behavior via the microbiota–gut–brain axis. However, the exact mechanisms are not fully identified. Recent evidence suggests the modulatory effect of synbiotics on gut microbiota and the contribution of these agents in ameliorating symptoms of many psychiatric diseases. To date, no randomized controlled trial has been performed to establish the feasibility and efficacy of this intervention targeting the reduction of impulsivity and compulsivity. We hypothesize that supplementation with synbiotics may be an effective treatment in adults with high levels of impulsivity and/or compulsivity. Methods/design This is a prospective, multicenter, double-blind, randomized controlled trial with two arms: treatment with a synbiotic formula versus placebo treatment. The primary outcome is the response rate at the end of the placebo-controlled phase (response defined as a Clinical Global Impression–Improvement Scale score of 1 or 2 = very much improved or much improved, plus a reduction in the Affective Reactivity Index total score of at least 30% compared with baseline). A total of 180 participants with highly impulsive behavior and a diagnosis of attention deficit/hyperactivity disorder (ADHD) and/or borderline personality disorder, aged 18–65 years old, will be screened at three study centers. Secondary outcome measures, including changes in general psychopathology, ADHD symptoms, neurocognitive function, somatic parameters, physical activity, nutritional intake, and health-related quality of life, will be explored at assessments before, during, and at the end of the intervention. The effect of the intervention on genetics, microbiota, and several blood biomarkers will also be assessed. Gastrointestinal symptoms and somatic complaints will additionally be explored at 1-week follow-up. Discussion This is the first randomized controlled trial to determine the effects of supplementation with synbiotics on reducing impulsive and compulsive behavior. This clinical trial can contribute to explaining the mechanisms involved in the crosstalk between the intestinal microbiome and the brain. If effects can be established by reducing impulsive and compulsive behavior, new cost-effective treatments might become available to these patients. Trial registration ClinicalTrials.gov, NCT03495375 . Registered on 26 February 2018.https://doi.org/10.1186/s13063-019-4040-xImpulsivityCompulsivityAggressionMicrobiomeProbioticsSynbiotics |
| spellingShingle | Gara Arteaga-Henríquez Silvia Karina Rosales-Ortiz Alejandro Arias-Vásquez Istvan Bitter Ylva Ginsberg Pol Ibañez-Jimenez Tünde Kilencz Catharina Lavebratt Silke Matura Andreas Reif Janos Rethelyi Vanesa Richarte Nanda Rommelse Anne Siegl J. Antoni Ramos-Quiroga Treating impulsivity with probiotics in adults (PROBIA): study protocol of a multicenter, double-blind, randomized, placebo-controlled trial Trials Impulsivity Compulsivity Aggression Microbiome Probiotics Synbiotics |
| title | Treating impulsivity with probiotics in adults (PROBIA): study protocol of a multicenter, double-blind, randomized, placebo-controlled trial |
| title_full | Treating impulsivity with probiotics in adults (PROBIA): study protocol of a multicenter, double-blind, randomized, placebo-controlled trial |
| title_fullStr | Treating impulsivity with probiotics in adults (PROBIA): study protocol of a multicenter, double-blind, randomized, placebo-controlled trial |
| title_full_unstemmed | Treating impulsivity with probiotics in adults (PROBIA): study protocol of a multicenter, double-blind, randomized, placebo-controlled trial |
| title_short | Treating impulsivity with probiotics in adults (PROBIA): study protocol of a multicenter, double-blind, randomized, placebo-controlled trial |
| title_sort | treating impulsivity with probiotics in adults probia study protocol of a multicenter double blind randomized placebo controlled trial |
| topic | Impulsivity Compulsivity Aggression Microbiome Probiotics Synbiotics |
| url | https://doi.org/10.1186/s13063-019-4040-x |
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