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Dysbiosis clinical trials

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NCT ID: NCT06460805 Recruiting - Inflammation Clinical Trials

axSEND: Exploring Immune and Microbiota Effects of a Partial Enteral Nutrition Diet in Axial Spondyloarthritis

axSEND
Start date: April 25, 2024
Phase: N/A
Study type: Interventional

People with axial spondyloarthritis (axSpA) often have intestinal inflammation and intestinal microbiome dysbiosis, with some similarities to Crohn's-like inflammatory bowel disease (IBD) gut inflammation. However, research has not addressed whether Partial Enteral Nutrition (PEN), a diet formed of a liquid formula and some solid whole foods, which is effective at inducing remission in IBD, may influence the dysbiotic microbiome and inflamed, hyperpermeable intestine of axSpA patients, and whether these changes may be accompanied by alterations in systemic markers of inflammation. Thus, there is a need to determine the effects of PEN on these aspects in axSpA patients. In this study, the investigators intend to trial a 2-week course (with optional additional 2-week extension) of a PEN diet in people with active axSpA disease. A group of healthy volunteers following the same diet will act as a control.

NCT ID: NCT06451588 Recruiting - Clinical trials for Ankylosing Spondylitis

Fecal Microbiota Transplantation in Axial Spondyloarthritis

MicroSpA
Start date: June 1, 2024
Phase: Phase 2
Study type: Interventional

Although biologic therapy have revolutionized the treatment of Spondyloarthrtitis (SpA), many patients do not experience complete relief of SpA related complaints. It has been established that patients with SpA have an altered composition of microorganisms (microbiota) in the gut compared to healthy controls, and that this correlates to disease activity and respons to therapy. The goal of this randomized double-blind study is to evaluate the efficacy of fecal microbiota transplantation (FMT) in patients with axial SpA with a suboptimal effect of biologic therapy. The main questions it aims to answer are: - Can FMT reduce disease activity in axial SpA? - Can FMT alleviate pain and reduce fatigue in axial SpA? - Is the composition of microorganisms restored to normal in patients with SpA after a treatment with FMT? Participants will receive a single treatment in the form of an enema with either donor FMT or placebo at baseline. The primary endpoint will be evaluated after 90 days, but efficacy and safety will be monitored from baseline until 365 days.

NCT ID: NCT06386471 Recruiting - Clinical trials for Cardiovascular Diseases

Personalized GI Motility Responses to Diet

Start date: March 7, 2024
Phase: N/A
Study type: Interventional

The goal of this randomized, crossover, clinical trial is to link: 1) gastrointestinal motility patterns induced by acute consumption of whole and refined grains, 2) enteric microbial production of bioactive metabolites, and 3) circulating postprandial appearance of metabolites important to cardiometabolic health including glucose, triglycerides, and cholesterol. Participants will be asked to consume a Smartpill monitoring device that records metrics of gastrointestinal motility in response to whole or refined grains, monitor cardiometabolic metabolties over an 8 hour postprandial window, and provide a fecal sample for microbiome-related analyses.

NCT ID: NCT06368895 Recruiting - Clinical trials for Hepatic Encephalopathy

Fecal Microbiota Transplantation by Oral Capsules for Hepatic Encephalopathy Treatment

Start date: April 7, 2021
Phase: Phase 1
Study type: Interventional

This interventional study aims to evaluate the safety and efficacy of oral capsule fecal microbiota transplantation (FMT) for treating hepatic encephalopathy refractory to conventional rifaximin and lactulose therapy in patients with liver cirrhosis. Patients diagnosed with hepatic encephalopathy refractory to rifaximin and lactulose therapy will be randomized into three groups. While continuing conventional therapy, the first group receives FMT via colonoscopy and oral capsule administration, the second group receives only oral capsule administration, and the third group serves as a control, receiving only conventional therapy. The aims of the study are: To evaluate the efficacy and safety of FMT by oral capsules in cirrhotic patients with hepatic encephalopathy refractory to standard therapy. To evaluate changes in the gut microbiota composition and in the intestinal and systemic inflammatory condition occurring after FMT and if they can be associated with clinical improvement. To evaluate metabolic modifications occurring after FMT and if they can be associated with clinical improvement.

NCT ID: NCT06196450 Recruiting - Clinical trials for Environmental Enteric Dysfunction

Maternal Probiotic Intervention to Improve Gut Health

MPIGH
Start date: June 22, 2023
Phase: Phase 2
Study type: Interventional

This trial will determine if a well-established probiotic, Vivomixx, can modulate maternal microbiota and ameliorate maternal environmental enteropathy which compromises growth in the first 1000 days. The probiotic Vivomixx has been used in many thousands of people including pregnant women, both within and outside a research context. This trial is the first in a proposed series of proof-of-concept intervention studies which are intended to provide data to enable a rational selection of interventions to be evaluated at scale in future large scale trials in which birth outcomes and postnatal growth will be key endpoints.

NCT ID: NCT06098404 Recruiting - Cancer Clinical Trials

Correlates of CRCI and Gut Microbiome Dysbiosis; a Pilot Study

Start date: March 4, 2024
Phase:
Study type: Observational

The aim of this study is to characterize the microbiome and assess fatigue and cognition of patients with cancer undergoing standard of care treatment.

NCT ID: NCT06095076 Recruiting - Dysbiosis Clinical Trials

Cutaneous Microbiota Evolution in ICU Patients With CVC (ICMc)

ICMc
Start date: June 2, 2023
Phase:
Study type: Observational

Intensive Care Unit (ICU) patients are exposed to catheter-related infections with an important morbidity. Catheter colonization is constant but infection is not. Cutaneous dysbiosis could be the missing link. Our study aims to evaluate the evolution of cutaneous microbiota in ICU patients with a central venous catheter in place, through metagenomics. Our main objective is to evaluate the evolution of alpha-diversity, quantified by intra-patient variation of Shannon diversity index (a diversity index used in bacterial metagenomics).

NCT ID: NCT06043154 Recruiting - Anorexia Nervosa Clinical Trials

Discovering New Insights Into Anorexia Nervosa: Influence of MicrObial DysbiosiS (DIAMOnDS)

DIAMOnDS
Start date: February 22, 2024
Phase: N/A
Study type: Interventional

This study will investigate the link between the gut microbiota, the occurrence of the central adiposity phenotype, and the patients' fear to regain weight in anorexia nervosa.

NCT ID: NCT06020703 Recruiting - COVID-19 Clinical Trials

A Study of Healthy Microbiome, Healthy Mind

Start date: February 26, 2024
Phase: N/A
Study type: Interventional

Researchers are doing this study to find out if a high fermented food diet is tolerable, and if it will help improve quality of life after surviving a critical illness, including severe COVID-19, by promoting gut health recovery and decreasing gut inflammation.

NCT ID: NCT06005298 Recruiting - HIV Infections Clinical Trials

Alcohol Misuse, Gut Microbial Dysbiosis and PrEP Care Continuum: Application and Efficacy of SBIRT Intervention

SEAL
Start date: October 1, 2023
Phase: N/A
Study type: Interventional

This randomized control trial study among Pre-exposure prophylactic users (PrEP) aims to learn and determine the efficacy of Screening, brief intervention, and referral to treatment (SBRIT) in reducing the risk of alcohol use. The main questions it aims to answer are: 1. How alcohol use impacts the PrEP continuum and to understand how early intervention and treatment approach affects alcohol use and PrEP adherence. 2. Investigate the effectiveness of the SBIRT intervention in preventing hazardous alcohol use and its impact on gut dysbiosis in PrEP users. 3. To determine alterations in the gut microbiome (dysbiosis), intestinal homeostasis, systemic inflammation, and markers of liver disease associated with hazardous alcohol use among PrEP users.