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.
journal_name
Trialsjournal_title
Trialsauthors
Arteaga-Henríquez G,Rosales-Ortiz SK,Arias-Vásquez A,Bitter I,Ginsberg Y,Ibañez-Jimenez P,Kilencz T,Lavebratt C,Matura S,Reif A,Rethelyi J,Richarte V,Rommelse N,Siegl A,Ramos-Quiroga JAdoi
10.1186/s13063-019-4040-xsubject
Has Abstractpub_date
2020-02-11 00:00:00pages
161issue
1issn
1745-6215pii
10.1186/s13063-019-4040-xjournal_volume
21pub_type
杂志文章相关文献
Trials文献大全abstract:BACKGROUND:The costs of medical research are a concern. Clinical Trials Units (CTUs) need to better understand variations in the costs of their activities. METHODS:Representatives of ten CTUs and two grant-awarding bodies pooled their experiences in discussions over 1.5 years. Five of the CTUs provided estimates of, a...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-017-1934-3
更新日期:2017-05-02 00:00:00
abstract::In ageing men testosterone levels decline, while cognitive function, muscle and bone mass, sexual hair growth, libido and sexual activity decline and the risk of cardiovascular diseases increase. We set up a double-blind, randomized placebo-controlled trial to investigate the effects of testosterone supplementation on...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/1745-6215-7-24
更新日期:2006-08-03 00:00:00
abstract:BACKGROUND:Ventilator-associated pneumonia (VAP) is one of the most common and severe hospital-adquired infections, and multidrugresistant gram-negative bacilli (MDR-GNB) constitute the main etiology in many countries. Inappropriate empiric antimicrobial treatment is associated with increased mortality. In this context...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/s13063-015-0614-4
更新日期:2015-03-20 00:00:00
abstract:BACKGROUND:Patients taking opioids are known to develop opioid-induced constipation (OIC), which reduces their quality of life. The aim of this study is to compare magnesium oxide with naldemedine and determine which is more effective in preventing OIC. METHODS:This proof-of-concept, prospective, randomized controlled...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-020-04385-0
更新日期:2020-06-01 00:00:00
abstract:BACKGROUND:Depressive and anxiety disorders are common in general practice but not always treated adequately. Introducing stepped care might improve this. In this randomized trial we examined the effectiveness of such a stepped care model. METHODS:The study population consisted of primary care attendees aged 18-65 yea...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-12-171
更新日期:2011-07-07 00:00:00
abstract:BACKGROUND:Classroom-based stuttering intervention addressing negative peer attitudes, perceptions, teasing and bullying of children who stutter (CWS) is required as part of holistic stuttering management because of its occurrence in primary school. This study was conducted in 2017, in 10 primary schools in the Western...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/s13063-018-3043-3
更新日期:2018-11-29 00:00:00
abstract:BACKGROUND:Graves' hyperthyroidism is an autoimmune disease causing hyperfunction of the thyroid gland. The concentration of selenium is high in the thyroid gland and two important groups of enzymes within the thyroid are selenoproteins, that is, they depend on selenium. Selenium may have beneficial effects on autoimmu...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/1745-6215-14-119
更新日期:2013-04-30 00:00:00
abstract:BACKGROUND:During the last decade, the use of ministernotomy in cardiac surgery has increased. Quality of life and patient satisfaction after ministernotomy have never been compared to conventional full sternotomy in randomised trials. The aim of the study is to determine if this minimally invasive approach improves qu...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-018-2486-x
更新日期:2018-02-17 00:00:00
abstract:BACKGROUND:Previous studies have shown that acupuncture and electroacupuncture (EA) are effective in the treatment of patients with low back pain. However, there is little evidence to support the use of one intervention over the other. The aim of this study is to compare the effect of acupuncture and electroacupuncture...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/s13063-015-0850-7
更新日期:2015-10-15 00:00:00
abstract:BACKGROUND:Loneliness in older people is associated with poor health-related quality of life (HRQoL). We undertook a parallel-group randomised controlled trial to evaluate the effectiveness and cost-effectiveness of telephone befriending for the maintenance of HRQoL in older people. An internal pilot tested the feasibi...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-15-141
更新日期:2014-04-24 00:00:00
abstract:BACKGROUND:Around 35-45 % of people in contact with services for a first episode of psychosis are using cannabis. Cannabis use is associated with delays in remission, poorer clinical outcomes, significant increases in the risk of relapse, and lower engagement in work or education. While there is a clear need for effect...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/s13063-016-1620-x
更新日期:2016-10-22 00:00:00
abstract:BACKGROUND:Neurofeedback has been applied effectively in various areas, especially in the treatment of children with attention-deficit/hyperactivity disorder (ADHD). This study protocol is designed to investigate the effect of slow cortical potential (SCP) feedback and a new form of neurofeedback using near-infrared sp...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/s13063-015-0683-4
更新日期:2015-04-18 00:00:00
abstract:OBJECTIVES:The GETAFIX trial will test the hypothesis that favipiravir is a more effective treatment for COVID-19 infection in patients who have early stage disease, compared to current standard of care. This study will also provide an important opportunity to investigate the safety and tolerability of favipiravir, the...
journal_title:Trials
pub_type: 信件,多中心研究,随机对照试验
doi:10.1186/s13063-020-04891-1
更新日期:2020-11-19 00:00:00
abstract:BACKGROUND:The risk of falling is significantly higher in people with chronic stroke and it is, therefore, important to design interventions to improve mobility and decrease falls risk. Minimum toe clearance (MTC) is the key gait cycle event for predicting tripping-falls because it occurs mid-swing during the walking c...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-019-3404-6
更新日期:2019-05-31 00:00:00
abstract:BACKGROUND:Increasing numbers of patients are surviving critical illness, but survival may be associated with a constellation of physical and psychological sequelae that can cause ongoing disability and reduced health-related quality of life. Limited evidence currently exists to guide the optimum structure, timing, and...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-15-38
更新日期:2014-01-29 00:00:00
abstract:BACKGROUND:South Africa is among the seven highest tuberculosis (TB) burden countries. Harmful lifestyle behaviours, such as smoking and alcohol, and poor adherence to medication can affect clinical outcomes. Modification of these behaviours is likely to improve TB treatment outcomes and has proven possible using motiv...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-019-3551-9
更新日期:2019-07-26 00:00:00
abstract:BACKGROUND:Bone graft substitutes are widely used for reconstruction of posttraumatic bone defects. However, their clinical significance in comparison to autologous bone grafting, the gold-standard in reconstruction of larger bone defects, still remains under debate. This prospective, randomized, controlled clinical st...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/1745-6215-15-75
更新日期:2014-03-08 00:00:00
abstract:BACKGROUND:Intrathecally administered morphine is effective as part of a postoperative analgesia regimen following major hepatopancreaticobiliary surgery. However, the potential for postoperative respiratory depression at the doses required for effective analgesia currently limits its clinical use. The use of a low-dos...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-017-2370-0
更新日期:2017-12-29 00:00:00
abstract:BACKGROUND:Allergic rhinitis is a chronic illness, affecting 10 to 40% of the worldwide population. Chinese herbal medicines, the treatment of allergic rhinitis, adopted thousands of years in ancient China, has recently raised much attention among researchers globally. This study evaluates the effects of two Chinese he...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-15-261
更新日期:2014-07-02 00:00:00
abstract:BACKGROUND:Three-dimensional (3D) stereoscopic vision is crucial to perform any kind of manual task. The reduction from real life 3D to virtual two-dimensional (2D) sight is a major challenge in minimally invasive surgery (MIS). A 3D display technique has been shown to reduce operation time and mistakes and to improve ...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-019-3330-7
更新日期:2019-05-28 00:00:00
abstract:BACKGROUND:Recruiting and retaining participants in randomised controlled trials (RCTs) is challenging. Digital tools, such as social media, data mining, email or text-messaging, could improve recruitment or retention, but an overview of this research area is lacking. We aimed to systematically map the characteristics ...
journal_title:Trials
pub_type: 杂志文章,评审
doi:10.1186/s13063-020-04358-3
更新日期:2020-06-05 00:00:00
abstract:OBJECTIVES:Primary Objective • To assess the efficacy of herbal extracts in boosting innate immunity of patients with COVID-19 infection. Secondary Objectives • To assess the efficacy of herbal extracts in restoring respiratory health • To assess the efficacy of Cap. IP in early recovery of patients and decline in vira...
journal_title:Trials
pub_type: 信件,随机对照试验
doi:10.1186/s13063-020-04906-x
更新日期:2020-11-23 00:00:00
abstract:BACKGROUND:Coronary artery disease is the leading cause of morbidity and mortality in patients with type 2 diabetes. Screening for asymptomatic coronary artery disease with treatment by means of revascularization seems to be an appealing option for prevention. The utility of such a strategy has never been challenged in...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-10-119
更新日期:2009-12-23 00:00:00
abstract:BACKGROUND:An individualized treatment algorithm (Copenhagen Achilles Rupture Treatment Algorithm (CARTA)) based on the ultrasonographic appearance of an acute Achilles tendon rupture has been developed aiming to select the correct patients for operative and non-operative treatment. The objective of this study is to in...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/s13063-020-04332-z
更新日期:2020-05-12 00:00:00
abstract:BACKGROUND:The increasing prevalence of Alzheimer's disease and other forms of dementia raises new challenges to ensure that healthcare decisions are informed by research evidence and reflect what is important for seniors and their caregivers. Therefore, we aim to evaluate a tailored intervention to help healthcare pro...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-018-2697-1
更新日期:2018-06-25 00:00:00
abstract:BACKGROUND:Maternal and perinatal mortality are major problems for which progress in sub-Saharan Africa has been inadequate, even though childbirth services are available, even in the poorest countries. Reducing them is the aim of two of the main Millennium Development Goals. Many initiatives have been undertaken to re...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-10-85
更新日期:2009-09-18 00:00:00
abstract:BACKGROUND:Randomized controlled trials (RCTs) often have more than one primary outcome and frequently have secondary and harm outcomes. Comparison of outcomes between study arms is the primary focus of RCTs, but there are times when the relation between outcomes is important, such as determining whether an intermediat...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-015-0584-6
更新日期:2015-02-22 00:00:00
abstract:UNLABELLED:Screening physical activity levels is common in trials to increase physical activity in inactive populations. Commonly applied single-item screening tools might not always be effective in identifying those who are inactive. We applied the more extensive Active Australia Survey to identify inactive people amo...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/s13063-015-0976-7
更新日期:2015-10-08 00:00:00
abstract:BACKGROUND:Quitting smokers gain weight. This deters some from trying to stop smoking and may explain the increased incidence of type 2 diabetes after cessation. Dieting when stopping smoking may be counterproductive. Hunger increases cravings for smoking and tackling two behaviours together may undermine quitting succ...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/1745-6215-14-182
更新日期:2013-06-19 00:00:00
abstract:BACKGROUND:Depression is a debilitating and costly disease for our society, especially in the case of treatment-resistant depression (TRD). Repetitive transcranial magnetic stimulation (rTMS) is an effective adjuvant therapy in treatment-resistant unipolar and non-psychotic depression. It can be applied according to tw...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-020-04255-9
更新日期:2020-04-05 00:00:00