Bothell

Researchers are evaluating the long-term safety and tolerability of dazodalibep in adults with Sjögren's Syndrome. This phase 3 open-label extension study focuses on participants who have previously received dazodalibep or placebo in earlier phase 3 trials and completed those studies through Week 48. Participants will receive dazodalibep intravenously during this long-term extension study. The first dose is administered around Week 48 (+28 days) following the prior phase 3 studies. The study monitors safety and tolerability over an extended period to assess treatment-emergent adverse events up to 152 weeks. During the study, participants will undergo regular evaluations to monitor their health and any side effects. Researchers will collect data on adverse events that emerge during treatment. The overall goal is to gather long-term safety information to better understand how participants tolerate dazodalibep when used over an extended time frame.

Researchers are collecting and analyzing a variety of physiological, physical, and molecular data from a diverse group of people to better understand how these factors relate to health and disease. The study focuses on general health and wellness, aiming to discover how different foods impact overall well-being. The hypothesis is that by tracking food intake patterns alongside lifestyle factors and non-invasive testing, personalized diet and lifestyle advice can be developed. Participants will collect samples such as stool, blood, saliva, cheek swabs, vaginal swabs, breast milk or colostrum, nasal swabs or washes, and urine. These samples will be sent to Viome laboratories or contract research organizations for detailed analysis, including genetic, transcriptomic, metabolomic, physiological, and physical evaluations. This is an observational study and involves no treatment or intervention. During the study, participants will provide samples at their convenience and send them for testing. Researchers will measure molecular markers of health and disease over a period of 10 years. The study emphasizes non-invasive sample collection and long-term monitoring to understand the connections between diet, lifestyle, and wellness.

Researchers are evaluating the effectiveness of Viome's Precision Nutrition Program (VPNP) in lowering HbA1c levels among adults with diabetes. This randomized, placebo-controlled trial targets participants with HbA1c levels between 6.5% and 8.9%. The study aims to understand how personalized diet and supplement recommendations based on microbiome analysis may impact blood sugar control over a 90-day period. During the study, participants will be randomly assigned to receive either personalized supplements or placebo supplements alongside dietary guidance through the Viome app. At the start, participants complete online questionnaires, a blood draw, and collect blood, stool, and saliva samples at home to send back for analysis. After 90 days of following the tailored nutrition plan and taking the supplements, these assessments and sample collections will be repeated to measure changes. Participants will be monitored through questionnaires and laboratory tests, including measurements of HbA1c and fasting insulin levels at 4 months. The study relies on participant adherence to the nutrition program and supplement intake, with data collected via the Viome app. The total involvement per participant is approximately 90 days, with evaluations conducted before and after the intervention to assess outcomes and safety.

Researchers are evaluating the effectiveness of Viome's Precision Nutrition Program (VPNP) in lowering HbA1c levels in adults with diabetes or prediabetes. This randomized, placebo-controlled trial recruits participants with HbA1c levels between 5.7% and 8.9%. The study is conducted entirely through direct-to-participant enrollment without additional clinical sites. Participants will be randomized to receive either personalized dietary recommendations and supplements based on their microbiome analysis or standard USDA dietary guidance with placebo supplements. At the start of the 90-day study, participants complete online questionnaires and provide blood, stool, and saliva samples both at home and through a blood draw. After analysis, participants follow their assigned nutrition plan and take supplements for 90 days. Throughout the study, participants will be monitored via questionnaires and repeat sample collections at the end of the 90 days. The study measures changes in HbA1c and insulin resistance to assess the program's impact. Participants must be willing and able to use a smartphone app and visit a Quest Diagnostic center for blood draws as part of their involvement.

Researchers are evaluating the safety and effectiveness of dapansutrile (OLT1177®) tablets in adults experiencing an acute gout flare. This multi-center Phase 2/3 study compares dapansutrile to a placebo in subjects who have had a gout flare within 96 hours before the first visit. The study aims to measure how well dapansutrile reduces joint pain compared to placebo 72 hours after the initial dose. Participants will be randomly assigned in a 2:1 ratio to receive either dapansutrile or a matching placebo. On Day 1, subjects will take an initial loading dose of 2000 mg dapansutrile or placebo, followed by 1000 mg or matching placebo tablets twice daily for 7 days. During the treatment period, no other pain or anti-inflammatory medications are allowed except for study-provided rescue medication. Visits are scheduled on Day 4, Day 8 after completing treatment, and Day 15 to monitor safety and treatment effects. Throughout the study, participants will undergo assessments including pain evaluations, safety monitoring, and data collection up to Day 36. Researchers will track joint pain reduction and monitor for any side effects or complications. The total participation includes treatment and follow-up visits over approximately five weeks, ensuring comprehensive data on the study treatments' efficacy and safety.

Researchers are evaluating the effects of Viome-designed supplements and the Viome Precision Nutrition Program on improving clinical outcomes in adults with gastrointestinal conditions, specifically irritable bowel syndrome (IBS). This study involves US residents aged 25 to 75 who have been diagnosed with IBS according to ROME IV criteria and have an IBS-SSS score between 125 and 450. Participants are randomly assigned to one of three groups to compare the impact of different supplement programs on gastrointestinal wellness over about four months. Participants receive one of three interventions: a placebo (control group), Viome-designed condition-based supplements (VCS), or the Viome Precision Nutrition Program (VPNP). The supplements and programs may include a combination of supplements, dietary recommendations, and coaching tailored to the participant's health conditions or microbiome sample results. The trial is conducted entirely remotely without clinical site visits. During the study, participants complete surveys and follow trial instructions using the Viome app on a smartphone. Researchers monitor gastrointestinal symptoms and clinical outcomes related to supplement efficacy over the four-month period. The study tracks participants' adherence, safety, and response to their assigned supplement program through questionnaires and app-based monitoring to assess the benefits on gastrointestinal health.

Researchers are evaluating the effects of Viome-designed condition-based supplements and the Viome Precision Nutrition Program on metabolic health in adults aged 25 to 75 years living in the United States. This trial aims to improve clinical outcomes related to metabolic conditions by comparing these two nutritional approaches against a placebo. Participants are randomized into one of three groups to assess the impact of these interventions over approximately four months. Participants are assigned to either receive placebo, Viome-designed condition-based supplements, or the Viome Precision Nutrition Program. Both Viome interventions may include supplements, diet recommendations, and coaching through an app. The Precision Nutrition Program uses supplements tailored to the participant’s microbiome sample results, while the condition-based supplements are formulated based on overall health conditions. The study is conducted remotely without clinical site visits. During the study, participants complete surveys at enrollment and follow trial instructions using the app. Researchers will monitor and evaluate the efficacy of the supplements and nutrition program over about four months by measuring clinical outcomes related to metabolic health. Participants must have recent medical records confirming elevated fasting insulin or glucose levels. Safety and adherence are supported through app coaching and monitoring of dietary and lifestyle changes throughout the study.

Researchers are evaluating the Viome Precision Nutrition Program to improve clinical outcomes for individuals with mental health issues such as depression and anxiety. This trial involves US residents aged 25 to 75 who experience these conditions and meet specific mental health score criteria. The study is conducted entirely remotely without clinical site visits, aiming to assess the effects of personalized nutrition and supplements on mental health symptoms over roughly four months. Participants are randomly assigned to one of two groups: one receiving a placebo and the other receiving the Viome Precision Nutrition Program. This program offers personalized supplements based on the participant's microbiome analysis, along with possible dietary recommendations and coaching. Both study arms involve supplement intake and diet guidance designed to support mental health symptom improvement. During the approximately four-month trial, participants complete surveys to measure changes in depression, anxiety, perceived stress, and quality of life. Researchers also analyze correlations between changes in the microbiome and clinical outcomes. Participants use Viome's app on their smartphones for study participation and monitoring. The study closely tracks mental health scores and overall well-being to evaluate the program's impact.