383 research outputs found

    Innovation Drivers in Microbiota R&D

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    Probiotic and synbiotic safety in infants under two years of age

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    In this study, we systematically evaluated safety aspects in clinical trials with probiotics and synbiotics in young infants (0-2 years of age). This study is an update of earlier reports and covers the recent literature from 2008-2013. The safety evaluation is performed along the Common Terminology Clinical Adverse Events (CTCAE) version 4.0 scale, hereby also providing guidance for future studies. Safety aspects are represented and related to number of participants per probiotic strain/culture, study duration, dosage, clinical condition and selected afflictions. The results show a deficiency in the precise reporting and classification of adverse events in most studies. Analysis of 57 clinical trials with probiotics and synbiotics in combination with eight follow-up studies indicate that probiotic administration to infants between 0 and 24 months is safe with regard to the evaluated strains in infants with a particular health status or susceptibility. Most adverse events and serious adverse events were considered unrelated to the study product, and there were no major safety concerns. Almost all studies concluded that none of the adverse effects were related to the study product; the study products are generally well tolerated. Finally, inconsistent, imprecise and potentially incomplete reporting as well as the variation in probiotic strains, dosages, administration regimes, study populations and reported outcomes, greatly limit the generalizability of conclusions and argue convincingly for obligatory and standardised behaviour on adverse events (CTCAE) reporting in 'food' studies

    Safety of probiotics and synbiotics in children under 18 years of age

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    This study aimed to systematically evaluate safety of probiotics and synbiotics in children ageing 0-18 years. This study is the third and final part in a safety trilogy and an update is provided using the most recent available clinical data (2008-2013) by means of the Common Terminology Clinical Adverse Events (CTCAE version 4.0) classification. Safety aspects are represented and related to number of participants per probiotic strain/culture, study duration, dosage, clinical condition and selected afflictions. Analysis of 74 clinical studies indicated that probiotic and/or synbiotic administration in children is safe with regard to the specific evaluated strains, dosages and duration. The population of children include healthy, immune compromised and obese subjects, as well as subjects with intestinal disorders, infections and inflammatory disorders. This study revealed no major safety concerns, as the adverse events (AEs) were unrelated, or not suspected to be related, to the probiotic or synbiotic product. In general the study products were well tolerated. Overall, AEs occurred more frequent in the control arm compared to children receiving probiotics and/or synbiotics. Furthermore, the results indicate inadequate reporting and classification of AEs in the majority of the studies. In addition, generalizability of conclusions are greatly limited by the inconsistent, imprecise and potentially incomplete reporting as well as the variation in probiotic strains, dosages, administration regimes, study populations and reported outcomes

    Protocol for the DeFOG trial: A randomized controlled trial on the effects of smartphone-based, on-demand cueing for freezing of gait in Parkinson's disease

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    Background: Freezing of gait (FOG) is a highly incapacitating symptom that affects many people with Parkinson's disease (PD). Cueing triggered upon real-time FOG detection (on-demand cueing) shows promise for FOG treatment. Yet, the feasibility of implementation and efficacy in daily life is still unknown. Therefore, this study aims to investigate the effectiveness of DeFOG: a smartphone and sensor-based on-demand cueing solution for FOG. Methods: Sixty-two PD patients with FOG will be recruited for this single-blind, multi-center, randomized controlled phase II trial. Patients will be randomized into either the intervention group or the active control group. For four weeks, both groups will receive feedback about their physical activity using the wearable DeFOG system in daily life. In addition, the intervention group will also receive on-demand auditory cueing and instructions. Before and after the intervention, home-based assessments will be performed to evaluate the primary outcome, i.e., “percentage time frozen” during a FOG-provoking protocol. Secondary outcomes include the training effects on physical activity monitored over 7 days and the user-friendliness of the technology. Discussion: The DeFOG trial will investigate the effectiveness of personalized on-demand cueing in a controlled design, delivered for 4 weeks in the patient's home environment. We anticipate that DeFOG will reduce FOG to a greater degree than in the control group and we will explore the impact of the intervention on physical activity levels. We expect to gain in-depth insight into whether and how patients control FOG using cueing methods in their daily lives. Trial registration: Clinicaltrials.gov NCT03978507

    Online programs as tools to improve parenting: A meta-analytic review.

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    a b s t r a c t a r t i c l e i n f o Background: A number of parenting programs, aimed at improving parenting competencies, have recently been adapted or designed with the use of online technologies. Although web-based services have been claimed to hold promise for parent support, a meta-analytic review of online parenting interventions is lacking. Method: A systematic review was undertaken of studies (n = 19), published between 2000 and 2010, that describe parenting programs of which the primary components were delivered online. Seven programs were adaptations of traditional, mostly evidence-based, parenting interventions, using the unique opportunities of internet technology. Twelve studies (with in total 54 outcomes, N tot parents = 1615 and N tot children = 740) were included in a meta-analysis. Results: The meta-analysis showed a statistically significant medium effect across parents outcomes (ES = 0.67; se = 0.25) and child outcomes (ES = 0.42; se = 0.15). Conclusions: The results of this review show that web-based parenting programs with new technologies offer opportunities for sharing social support, consulting professionals and training parental competencies. The meta-analytic results show that guided and self-guided online interventions can make a significant positive contribution for parents and children. The relation with other meta-analyses in the domains of parent education and web-based interventions is discussed

    Lactobacillus plantarum WCFS1 and its host interaction : a dozen years after the genome

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    Lactobacillus plantarum WCFS1 is one of the best studied Lactobacilli, notably as its genome was unravelled over 12years ago. L.plantarum WCFS1 can be grown to high densities, is amenable to genetic transformation and highly robust with a relatively high survival rate during the gastrointestinal passage. In this review, we present and discuss the main insights provided by the functional genomics research on L.plantarum WCFS1 with specific attention for the molecular mechanisms related to its interaction with the human host and its potential to modify the immune system, and induce other health-related benefits. Whereas most insight has been gained in mouse and other model studies, onlyfive human studies have been reported with L.plantarum WCFS1. Hence NCIMB 8826 (the parental strain of L.plantarum WCFS1) in human trials as to capitalize on the wealth of knowledge that is summarized here.Peer reviewe

    Wearable Haptic Devices for Gait Re-education by Rhythmic Haptic Cueing

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    This research explores the development and evaluation of wearable haptic devices for gait sensing and rhythmic haptic cueing in the context of gait re-education for people with neurological and neurodegenerative conditions. Many people with long-term neurological and neurodegenerative conditions such as Stroke, Brain Injury, Multiple Sclerosis or Parkinson’s disease suffer from impaired walking gait pattern. Gait improvement can lead to better fluidity in walking, improved health outcomes, greater independence, and enhanced quality of life. Existing lab-based studies with wearable devices have shown that rhythmic haptic cueing can cause immediate improvements to gait features such as temporal symmetry, stride length, and walking speed. However, current wearable systems are unsuitable for self-managed use for in-the-wild applications with people having such conditions. This work aims to investigate the research question of how wearable haptic devices can help in long-term gait re-education using rhythmic haptic cueing. A longitudinal pilot study has been conducted with a brain trauma survivor, providing rhythmic haptic cueing using a wearable haptic device as a therapeutic intervention for a two-week period. Preliminary results comparing pre and post-intervention gait measurements have shown improvements in walking speed, temporal asymmetry, and stride length. The pilot study has raised an array of issues that require further study. This work aims to develop and evaluate prototype systems through an iterative design process to make possible the self-managed use of such devices in-the-wild. These systems will directly provide therapeutic intervention for gait re-education, offer enhanced information for therapists, remotely monitor dosage adherence and inform treatment and prognoses over the long-term. This research will evaluate the use of technology from the perspective of multiple stakeholders, including clinicians, carers and patients. This work has the potential to impact clinical practice nationwide and worldwide in neuro-physiotherapy

    Adaptations to Postural Perturbations in Patients With Freezing of Gait

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    Introduction: Freezing of gait (FOG) is a powerful determinant of falls in Parkinson's disease (PD). Automatic postural reactions serve as a protective strategy to prevent falling after perturbations. However, differences in automatic postural reactions between patients with and without FOG in response to perturbation are at present unclear. Therefore, the present study aimed to compare the response patterns and neuromuscular control between PD patients with and without FOG and healthy controls (HCs) after postural perturbations.Methods: 28 PD patients (15 FOG+, 13 FOG−) and 22 HCs were included. Participants stood on a moveable platform while random perturbations were imposed. The first anterior platform translation was retained for analysis. Center of pressure (CoP) and center of mass (CoM) trajectories and trunk, knee and ankle angles were compared between the three groups using the Statistical Parametric Mapping technique, allowing to capture changes in time. In addition, muscle activation of lower leg muscles was measured using EMG.Results: At baseline, FOG+ stood with more trunk flexion than HCs (p = 0.005), a result not found in FOG−. Following a perturbation, FOG+ reacted with increased trunk extension (p = 0.004) in comparison to HCs, a pattern not observed in FOG−. The CoM showed greater backward displacement in FOG− and FOG+ (p = 0.008, p = 0.027). Both FOG+ and FOG− showed increased co-activation of agonist and antagonist muscles compared to HCs (p = 0.010), with no differences between FOG+ and FOG−.Conclusions: Automatic postural reactions after a sudden perturbation are similar between PD subgroups with and without FOG but different from HCs. Reactive postural control, largely regulated by brain stem centers, seems to be modulated by different mechanisms than those governing freezing of gait. Greater differences in initial stance position, enhanced by joint stiffening, could however underlie maladaptive postural responses and increase susceptibility for balance loss in FOG+ compared to FOG−

    Older Adults’ Views on Social Interactions and Online Socializing Games–A Qualitative Study

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    Age-related difficulties and quarantine restrictions impede the possibilities to maintain contact with one’s social network. Maintaining these contacts may be supported by digital games. To develop effective and feasible digital tools to foster social interaction, we aimed to explore what older adults find important in social contact and what barriers and enablers they foresee in digital gaming interventions as network support aids. Two focus groups and 20 semi-structured interviews (N = 29) with older adults (aged 55–87) were held to explore the research questions. Furthermore, a questionnaire was administered (N = 29) containing measures of loneliness, frailty, and social network size. Participants found ‘reciprocity’, ‘in-person contact’, and ‘personal connection’ important in contact with strong ties. Online games were not used much for socializing but may be used in the future, particularly by less mobile older adults. Future social gaming interventions should be challenging, user-friendly, and offer the possibility to communicate. Digital co-designed interventions that are feasible, challenging, intuitive, and trigger meaningful communication may strengthen social interactions in older adults. They may be a relevant social support tool in periods of interaction limitations due to functional impairment or social isolation
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