Red Desaturation Prevalence and Severity in Healthy Patients.

Background and Objectives: To determine the percentage of the healthy population that responds asymmetrically to the red desaturation test and to approximate the degree of red desaturation in those individuals. We also sought to elucidate any correlation between demographic variables and red desaturation prevalence and severity. Methods: Adults aged 18 years and older with a normal eye examination, including confrontation fields and best-corrected visual acuity of ≥20/25 in both eyes, were eligible for this prevalence study. Those with objective or subjective afferent visual dysfunction were excluded. A total of 101 eligible participants (68.3% female and 31.7% male; racial/ethnic breakdown of 77.2% White, 11.9% Black, 8.9% Asian, 2.0% N/A; mean (SD) age: 41.5 (15.3) years) were queried whether the monocular perception of redness of a standardized tropicamide bottle cap was the same and to estimate the interocular percentage difference, with 1 eye perceiving the bottle cap at "100% redness." Results: Twenty-four participants (23.8%) experienced some degree of red desaturation. For these individuals with red desaturation, the average interocular difference was 9.0% (range 2%-25%, 95% confidence interval 6.0%-12.0%). There was no statistical evidence for a relationship between red desaturation and race, sex, or age. Discussion: This study shows that nearly a quarter of healthy patients without apparent optic nerve or macular dysfunction may recognize red desaturation. This deserves consideration when interpreting red desaturation testing in patients suspected to have unilateral optic neuropathy. Further research with larger sample sizes may identify predictors of red desaturation in healthy patients, establish the red desaturation threshold separating pathologic from physiologic phenomena, and assess the repeatability of red desaturation over time in affected individuals.

A double-blind, 377-subject randomized study identifies Ruminococcus, Coprococcus, Christensenella, and Collinsella as long-term potential key players in the modulation of the gut microbiome of lactose intolerant individuals by galacto-oligosaccharides.

Background. Our recent publication (Chey et al., Nutrients 2020) showed that a 30-day administration of pure galacto-oligosaccharides (GOS) significantly reduced symptoms and altered the fecal microbiome in patients with lactose intolerance (LI). Results. In this addendum, we performed an in-depth analysis of the fecal microbiome of the 377 LI patients randomized to one of two GOS doses (Low, 10-15 grams/day or High, 15-20 grams/day), or placebo in a multi-center, double-blinded, placebo-controlled trial. Sequencing of 16S rRNA amplicons was done on GOS or placebo groups at weeks zero (baseline), four (end of treatment), nine, 16 and 22. Taxa impacted by treatment and subsequent dairy consumption included lactose-fermenting species of Bifidobacterium, Lactobacillus, Lactococcus, and Streptococcus. Increased secondary fermentation microorganisms included Coprococcus and Ruminococcus species, Blautia producta, and Methanobrevibacterium. Finally, tertiary fermenters that use acetate to generate butyrate were also increased, including Faecalibacterium prausnitzii, Roseburia faecis, and C. eutactus. Conclusions. Results confirmed and expanded data on GOS microbiome modulation in LI individuals. Microbiome analysis at 16 and 22 weeks after treatment further suggested relatively long-term benefits when individuals continued consumption of dairy products.

SARS-CoV-2 Infections and Serologic Responses Among Military Personnel Deployed on the USNS COMFORT to New York City During the COVID-19 Pandemic.

BACKGROUND: Coronavirus disease 2019 (COVID-19) presents a unique challenge to United States Navy hospital ships. The aim of this study was to determine the prevalence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection among US Navy personnel deployed on the USNS COMFORT to augment the inpatient health care capacity in New York City. METHODS: This was a cross-sectional study conducted on USNS COMFORT crewmembers returning to Norfolk, Virginia, following deployment. Participants completed an electronic questionnaire and provided a serum sample at Day 14 post-deployment. Polymerase chain reaction (PCR) results from testing of symptomatic crewmembers during deployment and Day 0 and Day 14 post-deployment screening swabs conducted on all crewmembers, per military order, were abstracted. SARS-CoV-2 infection was defined as a positive SARS-CoV-2 spike glycoprotein immunoglobulin G antibody or PCR result. RESULTS: Of the ship's total complement of 1200 crewmembers, 450 were enrolled: 432 (96.0%) completed the questionnaire and provided a serum sample. The median age of participants (interquartile range) was 30 (24-39) years, 50.8% were female, 58.6% were White, and 14.0% were Black; 80.1% had a clinical role during deployment. The cumulative prevalence of SARS-CoV-2 infection was 3.01% (13/432; 95% CI, 1.61%-5.09%). Twelve of 13 infections occurred in health care providers, and 8 of 13 were asymptomatic. The antibody profile of infected crewmembers varied by suspected timing of infection. CONCLUSIONS: We observed a low prevalence of SARS-CoV-2 infection among USNS COMFORT crewmembers despite the inherent risk of a shipboard deployment to an area with high rates of community transmission. Our findings suggest that early infection control measures mitigated the spread of SARS-CoV-2 among crewmembers.

Galacto-Oligosaccharide RP-G28 Improves Multiple Clinical Outcomes in Lactose-Intolerant Patients.

Background and Aims: Lactose intolerance (LI) is a global problem affecting more than half of the world's population. An ultra-purified, high-concentration galacto-oligosaccharide, RP-G28, is being developed as a treatment for patients with LI. The efficacy and safety of RP-G28 in reducing symptoms of lactose intolerance were assessed in a blinded, randomized, placebo-controlled trial. Methods: In this multiclinical site, double-blinded, placebo-controlled trial, 377 patients with LI were randomized to one of two doses of orally administered RP-G28 or placebo for 30 days. A LI test and symptom assessment were performed at baseline and on day 31. The primary endpoint was a ≥4-point reduction or a score of zero on LI composite score on day 31. Voluntary milk and dairy intake and global outcome measures assessed patients' overall treatment satisfaction and quality of life before therapy and 30 days after therapy. This study received Institutional Review Board (IRB) approval. Results: For the primary endpoint, 40% in the RP-G28 groups reported a ≥4-point reduction or no symptoms on LI symptom composite score compared to 26% with placebo (P = 0.016). Treatment with RP-G28 also led to significantly higher levels of milk and dairy intake and significant improvements in global assessments compared to placebo. RP-G28 but not placebo led to significant increases in five Bifidobacterium taxa. Conclusions: RP-G28 for 30 days significantly reduced symptoms and altered the fecal microbiome in patients with LI. Treatment with RP-G28 also improved milk/dairy consumption and quality of life and was safe and well tolerated.

Rural and urban patients with diffuse large B-cell and follicular lymphoma experience reduced overall survival: a National Cancer DataBase study.

We examined 83,108 patients with diffuse large B-cell lymphoma (DLBCL) and 43,393 patients with follicular lymphoma (FL) to investigate disparities related to geographic population density, stratified as rural, urban, or metropolitan. We found that urban and rural patients less commonly had private insurance and high socioeconomic status. Urban and rural DLBCL patients were more likely to receive treatment within 14 days of diagnosis (OR 0.93, 95% confidence interval [CI] 0.89-0.98; and OR 0.81, 95% CI 0.72-0.91) while urban FL patients were more likely to have treatment >14 days after diagnosis (OR 1.08, 95% CI 1.01-1.16). Multivariable analyses demonstrated that rural and urban patients had worse overall survival with DLBCL (hazard ratio [HR] 1.09; 95% CI 1-1.19 and HR 1.08; 95% CI 1.04-1.11) and FL (HR 1.11; 95% CI 1.04-1.18 and HR 1.2; 95% CI 1.02-1.41), respectively, suggesting needs for focused study and interventions for these populations.

Outcomes After Paravalvular Leak Closure: Transcatheter Versus Surgical Approaches.

OBJECTIVES: The aim of this study was to compare outcomes of transcatheter intervention (TI) versus surgical intervention (SI) for paravalvular leak (PVL). BACKGROUND: Data comparing the treatment of PVL with TI and SI are limited. METHODS: A retrospective cohort study was conducted comparing baseline characteristics, procedural details, and 1-year survival in consecutive patients who underwent TI or SI for moderate or greater PVL from 2007 to 2016. The primary outcome was a composite of death, reintervention for PVL, or readmission for congestive heart failure-related symptoms at 1 year. RESULTS: Of 114 patients, 56 underwent TI and 58 underwent SI. PVL locations were mitral, aortic, and pulmonary in 69 (60.5%), 39 (34.2%), and 6 (5.3%) patients, respectively. At baseline, TI patients were older (age 71 vs. 62 years; p = 0.010) and had fewer cases of active endocarditis (0.0% vs. 25.9%, p < 0.001) than SI patients. The TI group had a shorter post-operative stay (4 vs. 8 days; p < 0.001), a shorter intensive care unit stay (0 vs. 3 days; p < 0.001), and fewer readmissions at 30 days (8.9% vs. 25.9%; p = 0.017). There were no differences in the primary endpoint (TI 33.9% vs. SI 39.7%; p = 0.526) or 1-year survival (TI 83.9% vs. SI 75.9%; p = 0.283) between groups. CONCLUSIONS: In this study, TI for PVL closure had comparable 1-year clinical outcomes with SI, even after adjusting for differences in baseline characteristics, with less in-hospital morbidity and 30-day rehospitalization. Although further study is needed, these findings support the increased implementation of TI for PVL closure at experienced institutions.

Impact of short-chain galactooligosaccharides on the gut microbiome of lactose-intolerant individuals.

Directed modulation of the colonic bacteria to metabolize lactose effectively is a potentially useful approach to improve lactose digestion and tolerance. A randomized, double-blind, multisite placebo-controlled trial conducted in human subjects demonstrated that administration of a highly purified (>95%) short-chain galactooligosaccharide (GOS), designated "RP-G28," significantly improved clinical outcomes for lactose digestion and tolerance. In these individuals, stool samples were collected pretreatment (day 0), after GOS treatment (day 36), and 30 d after GOS feeding stopped and consumption of dairy products was encouraged (day 66). In this study, changes in the fecal microbiome were investigated using 16S rRNA amplicon pyrosequencing and high-throughput quantitative PCR. At day 36, bifidobacterial populations were increased in 27 of 30 of GOS subjects (90%), demonstrating a bifidogenic response in vivo. Relative abundance of lactose-fermenting Bifidobacterium, Faecalibacterium, and Lactobacillus were significantly increased in response to GOS. When dairy was introduced into the diet, lactose-fermenting Roseburia species increased from day 36 to day 66. The results indicated a definitive change in the fecal microbiome of lactose-intolerant individuals, increasing the abundance of lactose-metabolizing bacteria that were responsive to dietary adaptation to GOS. This change correlated with clinical outcomes of improved lactose tolerance.

Improving lactose digestion and symptoms of lactose intolerance with a novel galacto-oligosaccharide (RP-G28): a randomized, double-blind clinical trial.

BACKGROUND: Lactose intolerance (LI) is a common medical problem with limited treatment options. The primary symptoms are abdominal pain, diarrhea, bloating, flatulence, and cramping. Limiting dairy foods to reduce symptoms contributes to low calcium intake and the risk for chronic disease. Adaptation of the colon bacteria to effectively metabolize lactose is a novel and potentially useful approach to improve lactose digestion and tolerance. RP-G28 is novel galacto-oligosaccharide (GOS) being investigated to improve lactose digestion and the symptoms of lactose intolerance in affected patients. METHODS: A randomized, double-blind, parallel group, placebo-controlled study was conducted at 2 sites in the United States. RP-G28 or placebo was administered to 85 patients with LI for 35 days. Post-treatment, subjects reintroduced dairy into their daily diets and were followed for 30 additional days to evaluate lactose digestion as measured by hydrogen production and symptom improvements via a patient-reported symptom assessment instrument. RESULTS: Lactose digestion and symptoms of LI trended toward improvement on RP-G28 at the end of treatment and 30 days post-treatment. A reduction in abdominal pain was also demonstrated in the study results. Fifty percent of RP-G28 subjects with abdominal pain at baseline reported no abdominal pain at the end of treatment and 30 days post treatment (p = 0.0190). RP-G28 subjects were also six times more likely to claim lactose tolerance post-treatment once dairy foods had been re-introduced into their diets (p = 0.0389). CONCLUSIONS: Efficacy trends and favorable safety/tolerability findings suggest that RP-G28 appears to be a potentially useful approach for improving lactose digestion and LI symptoms. The concurrent reduction in abdominal pain and improved overall tolerance could be a meaningful benefit to lactose intolerant individuals.