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Clinical Trials: Bacterial and Fungal
IRB No. 12-009-2 (Dr. Jayesh Kamath, PI): Bronchiectasis Research Registry: A Consolidated Database of Non-Cystic Fibrosis Bronchiectasis Patients from Major Clinical and Research Institutions
Study description not available
This research study aims to identify the microbiome (the genetic material of microrganisms) present in inverse/genital psoriasis sites and the oral site. This may help us understand what causes or worsens inverse/genital psoriasis. By identifying what causes/worsens psoriasis and the kind of microorganisms involved, we can begin to better understand the best way to prevent or treat these types of conditions.
IRB No. 21-167JS-1 (Dr. Daniel Rosenberg, PI): Microbiota, Metabolites and Colon Neoplasia
Dr. Daniel W. Rosenberg and his project Co-Investigators are conducting a research study called ";Microbiota, Metabolites, and Colon Neoplasia"; to examine whether eating walnuts can have a beneficial effect on the gut bacteria population and the tissue that lines the inside of the colon in healthy individuals. Background & Hypothesis The human diet can positively or negatively impact cancer incidence, with plant-derived compounds - such as polyphenols - often exhibiting antioxidant cancer-preventive properties. Walnuts are an exceptional source of polyphenolic ellagitannins (ETs) that are converted to ellagic acid and various urolithins by gut microbiota in the colon. Urolithin A (UroA) is of particular interest for its potent anti-cancer, anti-inflammatory, and prebiotic activities. However, UroA production in individuals can vary significantly, likely based on differences in gut microbiota. We will substantiate the anti-cancer benefits of a prebiotic/probiotic complex derived from consuming walnuts and determine the basis of human inter-individual variability in UroA formation. Our overall hypothesis is that walnut supplementation improves colonic health and lowers colorectal cancer (CRC) risk through UroA formation. Study Design This is a controlled clinical trial to examine the effects of walnuts on CRC risk factors. Rationale While gut associated microbial metabolism of food-derived ETs is correlated with cardiovascular risk biomarkers, ET metabolism and how it relates to CRC risk has not been evaluated. Urolithins affect numerous cell signaling pathways relevant to cancer. The wide range of urolithin bioactivity provides the rationale for studying their potential cancer preventive properties. As part of an ongoing clinical study of early colonic neoplasia, our laboratory optimized ultra-sensitive analytical pipelines to perform a wide range of 'omics' analyses on human mucosal biopsies. This includes our recent study of the 'adherent' microbiome, raising the possibility that microbiota influence early CRC development, a time when prevention strategies are most efficacious. Our newly published findings demonstrate the feasibility of our analytical pipeline and our ability to associate molecular changes in the host colonic mucosa with the microbiota. Ultimately, these human and preclinical mouse studies may lead to the application of prebiotics and probiotics that enhance formation of protective urolithins for CRC prevention. These studies are of high significance as they will test the ability of the microbiota to generate agents (e.g., UroA) protective of the colonic mucosa. It is possible that high-risk patients can be efficiently converted to a protective state by taking probiotics to realize the full benefits of ET-rich foods. Study Population and Sample Size Men or women between the ages of 45-75 years who are scheduled to undergo a routine screening or surveillance colonoscopy for CRC. A total of 1,200 subjects will be enrolled across two sites (UConn Health and Weill Cornell Medicine). Major Study Interventions Subjects will be asked to consume 2 ounces of walnuts daily for 3 weeks prior to their routine colonoscopy. Food surveys, and blood, urine and stool samples will be collected at 2 time points over the course of study participation. A total of 8-10 colon biopsy specimens will be collected during a subject's colonoscopy procedure for the purposes of this study. Main Outcome Measures/Analyses 1) Association of the presence of colon lesions (AAs or SSA/Ps) with UroA production to assess whether UroA is associated with at-risk patients. 2) Identification and isolation of specific bacteria in the microbiome that either promote or impair urolithin synthesis and metabolism, and determine whether they have probiotic activity. 3) We will test whether the consumption of walnuts can elicit beneficial changes to host microbiota and associated functional metabolites (e.g., bile acids [BAs], SCFAs) in human colon. 4) Fecal (or bacterial) microbiome transplants will test for a causal link between UroA formation and cancer protection.
IRB No. 22-232-2 (Dr. Juan Salazar, PI): Elucidation of Treponema pallidum-specific antibodies in human syphilitic serum.
Syphilis, a multistage, sexually transmitted infection is caused by the highly invasive and immuno-evasive spirochete Treponema pallidum subsp. pallidum (T. pallidum) (1, 2). Syphilis remains a major global public health threat causing approximately seven million new infections annually (3, 4). Although the efficacy of penicillin therapy for syphilis remains undiminished after more than seven decades of use (1, 5), the explosive resurgence of the disease in the new millennium has fueled a sense of urgency for a vaccine with global efficacy (6, 7) and the World Health Organization has set ambitious targets to reduce the incidence of syphilis by 90% by 2030. T. pallidum is an extracellular pathogen (8, 9), with a low abundance of surface proteins, known as outer membrane proteins (OMPs). OMPs form b-barrels with large extracellular loops (ECLs) that extend from the surface of the organism into the extracellular space. These ECLs are acceptable to antibodies produced during infection with the spirochete. It is generally believed that these antibodies are critical for spirochete clearance and subsequent containment of the pathogen (10, 11). Ex vivo studies have demonstrated that antibodies in human syphilitic serum promote uptake and degradation of T. pallidum by professional phagocytes, such as macrophages (12, 13). The exact target(s) of the antibodies present in human syphilitic serum that lead to uptake of the spirochete has yet to be determined. Strategies for vaccine design often are predicated on the ';learning from nature'; paradigm that immunization should mimic the protective response evoked by the infecting pathogen (14). Extrapolating to syphilis, a successful vaccine should elicit antibodies against targets on the T. pallidum surface, with opsonic activity serving as an ex vivo correlate of protective immunity (10, 11). Having knowledge about the antigenic response to T. pallidum OMPs, more specifically ECLs, of a given serum sample or ECL-specific monoclonal antibodies in the ex vivo human macrophage system may give rise to novel vaccine candidate against an organism that has been plaguing mankind for centuries Hypotheses or Research Question, Aims and Objectives: Hypothesis/Question: To address the above information gaps, this study seeks to illuminate the key antibodies present in human syphilitic serum that lead to the clearance of spirochetal infection. Aims / objectives: Confirm samples of syphilitic serum evaluated have opsonic potential to pathogenic spirochetes. Use an ex vivo human macrophage system to investigate how human syphilitic serum and/or T. pallidum-specific monoclonal antibodies influence innate immune responses. Study how the antibody-opsonized spirochetes shape innate responses imminent adaptive responses in syphilis.