Efficacy of probiotic treatment as post-exposure prophylaxis for COVID-19: A double-blind, Placebo-Controlled Randomized trial.

BACKGROUND & AIMS: The COVID-19 pandemic continues to pose unprecedented challenges to worldwide health. While vaccines are effective, additional strategies to mitigate the spread/severity of COVID-19 continue to be needed. Emerging evidence suggests susceptibility to respiratory tract infections in healthy subjects can be reduced by probiotic interventions; thus, probiotics may be a low-risk, low-cost, and easily implementable modality to reduce risk of COVID-19. METHODS: In this initial study, we conducted a randomized, double-blind, placebo-controlled trial across the United States testing probiotic Lacticaseibacillus rhamnosus GG (LGG) as postexposure prophylaxis for COVID-19 in 182 participants who had household exposure to someone with confirmed COVID-19 diagnosed within ≤7 days. Participants were randomized to receive oral LGG or placebo for 28 days. The primary outcome was development of illness symptoms within 28 days of COVID-19 exposure. Stool was collected to evaluate microbiome changes. RESULTS: Intention-to-treat analysis showed LGG treatment led to a lower likelihood of developing illness symptoms versus placebo (26.4 % vs. 42.9 %, p = 0.02). Further, LGG was associated with a statistically significant reduction in COVID-19 diagnosis (log rank, p = 0.049) via time-to-event analysis. Overall incidence of COVID-19 diagnosis did not significantly differ between LGG and placebo groups (8.8 % vs. 15.4 %, p = 0.17). CONCLUSIONS: This data suggests LGG is associated with prolonged time to COVID-19 infection, reduced incidence of illness symptoms, and gut microbiome changes when used as prophylaxis ≤7 days post-COVID-19 exposure, but not overall incidence. This initial work may inform future COVID-19 prevention studies worldwide, particularly in developing nations where Lacticaseibacillus probiotics have previously been utilized to reduce other non-COVID infectious-morbidity. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04399252, Date: 22/05/2020. https://clinicaltrials.gov/ct2/show/NCT04399252.

Metabolic syndrome prevalence and impact on outcomes in patients with chronic graft-versus-host disease.

Patients with chronic graft-versus-host disease (cGVHD) are at heightened risk for components of metabolic syndrome (MetS), yet the prevalence and impact of MetS in the cGVHD patient population remain unknown. Adult patients (n = 229) with cGVHD enrolled in the cross-sectional NIH cGVHD Natural History Study (NCT00092235) were evaluated for MetS at enrollment and for variables associated with MetS. A majority (54.1%, 124/229) of the cohort met the diagnostic criteria for MetS. Patients with higher body mass index and lower performance status scores were more likely to have MetS (P < 0.0001; P = 0.026; respectively). Higher circulating erythrocyte sedimentation rate, C-reactive protein, and creatinine concentrations, along with lower estimated glomerular filtration rate, were associated with MetS (P < 0.001; P < 0.004; P = 0.02; P = 0.002; respectively). Patients with MetS compared to patients without MetS had no statistical differences in survival or NRM (5-year OS: 64% [95% CI: 54.8-71.8%] vs. 75.1% [95% CI: 65.6-82.3%]; respectively; overall P = 0.20; 5-year NRM: 21.7% [95% CI: 13.6-30.9%] vs. 10.1% [95% CI: 4.4-18.7%]; respectively; overall P = 0.12). Additionally, there was no difference in cGVHD severity between the two groups. Given the high prevalence of MetS in this cohort, clinicians should screen for its presence before it develops into comorbidities that complicate the course of cGVHD treatment.

eHealth-Generated Patient Data in an Outpatient Setting after Hematopoietic Stem Cell Transplantation: A Scoping Review.

Hematopoietic stem cell transplantation (HCT) has the potential to cure malignant and nonmalignant diseases but remains associated with a wide range of complications, necessitating dedicated lifelong follow-up. While patients are monitored closely during the peri-HCT period, leaving the hospital setting after HCT introduces new challenges. This scoping review explores the current use of patient-generated eHealth data in the outpatient setting. A systematic search of the PubMed, Scopus, Cumulative Index to Nursing and Allied Health Literature, American Psychological Association PsycINFO, and International Health Technology Assessment databases in July 2021 identified the 22 studies (13 full text articles and 9 abstracts) included in this review. The large majority were small to medium-sized (n = 15; 68.2%) pilot or feasibility studies (n = 18; 81.8%) that were published between 2016 and 2021 (n = 16; 72.7%). Collection of patient-reported outcomes was the most frequently reported eHealth intervention (n = 14; 63.6%), followed by vital sign monitoring (n = 5; 22.7%) and home-based spirometry (n = 3; 13.6%), mostly in the early post-transplantation setting. eHealth interventions had favorable feasibility and acceptability profiles; however, we found little data on the efficacy, long-term monitoring, data security, and cost-effectiveness of eHealth interventions. Larger randomized studies are warranted to draw formal conclusions about the impact of eHealth on HCT outcomes and the best ways to incorporate eHealth in clinical practice.

High-dose, high-frequency ustekinumab therapy for patients with severe hidradenitis suppurativa.

In this case series, ustekinumab therapy demonstrated efficacy in some patients with severe hidradenitis suppurativa previously treated with adalimumab and/or infliximab. Larger prospective studies are needed to evaluate ustekinumab as a treatment option for recalcitrant hidradenitis suppurativa.

Pitfalls and Successes in Trials in Older Transplant Patients with Hematologic Malignancies.

PURPOSE OF REVIEW: Recent medical advances have allowed a greater number of older patients to undergo hematopoietic stem cell transplantation (HSCT) and participate in HSCT trials. In this review, we outline recent advances in HSCT that have made this possible, general setbacks, and their effects on the landscape of HSCT trials in older adults. RECENT FINDINGS: Reduced-intensity conditioning regimens and a more physiological approach to transplant candidate selection have given older patients an opportunity to participate in HSCT trials. However, difficulties in allogeneic donor selection, post-transplant complications, and the misalignment of trial goals with patient goals may pose challenges for future trial recruitment and success. While increasing amounts of evidence show that older adults may benefit from participation in HSCT trials, clinicians, investigators, and patients must carefully weigh the benefits with potential repercussions.