Background A diet high in fermentable, oligo-, di-, monosaccharides and polyols (FODMAPs) has been shown to exacerbate symptoms of irritable bowel syndrome (IBS). Previous literature reports significant improvement in IBS symptoms with initiation of a low FODMAP diet (LFD) and monitored reintroduction. However, dietary adherence to the LFD is difficult, with patients stating that the information given by health care providers is often generalized and nonspecific, requiring them to search for supplementary information to fit their needs. Objective The aim of our study was to determine whether Heali, a novel artificial intelligence dietary mobile app can improve adherence to the LFD, IBS symptom severity, and quality of life outcomes in adults with IBS or IBS-like symptoms over a 4-week period. Methods Participants were randomized into 2 groups: the control group (CON), in which participants received educational materials, and the experimental group (APP), in which participants received access to the mobile app and educational materials. Over the course of this unblinded online trial, all participants completed a battery of 5 questionnaires at baseline and at the end of the trial to document IBS symptoms, quality of life, LFD knowledge, and LFD adherence. Results We enrolled 58 participants in the study (29 in each group), and 25 participants completed the study in its entirety (11 and 14 for the CON and APP groups, respectively). Final, per-protocol analyses showed greater improvement in quality of life score for the APP group compared to the CON group (31.1 and 11.8, respectively; P=.04). Reduction in total IBS symptom severity score was 24% greater for the APP group versus the CON group. Although this did not achieve significance (–170 vs –138 respectively; P=.37), the reduction in the subscore for bowel habit dissatisfaction was 2-fold greater for the APP group than for the CON group (P=.05). Conclusions This initial study provides preliminary evidence that Heali may provide therapeutic benefit to its users, specifically improvements in quality of life and bowel habits. Although this study was underpowered, findings from this study warrant further research in a larger sample of participants to test the efficacy of Heali app use to improve outcomes for patients with IBS. Trial Registration ClinicalTrials.gov NCT04256551; https://clinicaltrials.gov/ct2/show/NCT04256551
The Centre for Health Record Linkage (CHeReL) was established in 2006 as a dedicated health and human services data linkage facility for two Australian jurisdictions, New South Wales and the Australian Capital Territory, with the primary purpose of making linked administrative and routinely collected health data available to researchers and government within relevant regulatory and governance frameworks. Data governance and technical operations draw on international best practice and have been refined by learnings from other centres. More than 2,320 investigators from 140 institutions have used the CHeReL and produced 615 peer reviewed publications. A robust pipeline of new development is expected to further amplify linked data use for cutting edge medical research and support a vision of data-informed policy and data-driven government services.
BackgroundNosocomial infections remain an important source of morbidity, mortality, and increased health care costs in hospitalized patients. This is particularly problematic in intensive care units (ICUs) because of increased patient vulnerability due to the underlying severity of illness and increased susceptibility from utilization of invasive therapeutic and monitoring devices. Lactoferrin (LF) and the products of its breakdown have multiple biological effects, which make its utilization of interest for the prevention of nosocomial infections in the critically ill.Methods/designThis is a phase II randomized, multicenter, double-blinded trial to determine the effect of LF on antibiotic-free days in mechanically ventilated, critically ill, adult patients in the ICU. Eligible, consenting patients will be randomized to receive either LF or placebo. The treating clinician will remain blinded to allocation during the study; blinding will be maintained by using opaque syringes and containers. The primary outcome will be antibiotic-free days, defined as the number of days alive and free of antibiotics 28 days after randomization. Secondary outcomes will include: antibiotic utilization, adjudicated diagnosis of nosocomial infection (longer than 72 h of admission to ICU), hospital and ICU length of stay, change in organ function after randomization, hospital and 90-day mortality, incidence of tracheal colonization, changes in gastrointestinal permeability, and immune function. Outcomes to inform the conduct of a larger definitive trial will also be evaluated, including feasibility as determined by recruitment rates and protocol adherence.DiscussionThe results from this study are expected to provide insight into a potential novel therapeutic use for LF in critically ill adult patients. Further, analysis of study outcomes will inform a future, large-scale phase III randomized controlled trial powered on clinically important outcomes related to the use of LF.Trial registrationThe trial was registered at www.ClinicalTrials.gov on 18 November 2013. Trial registration number: NCT01996579.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1590-z) contains supplementary material, which is available to authorized users.
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