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Dysbiosis clinical trials

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NCT ID: NCT03554278 Active, not recruiting - Clinical trials for Necrotizing Enterocolitis

Alteration of Stool Microbiota in Preterm Infants With Anemia

Start date: October 9, 2018
Phase:
Study type: Observational

This study evaluates the relationship between anemia and stool microbiota in premature infants. It also evaluates the relationship between blood transfusion and stool microbiota.

NCT ID: NCT03548051 Terminated - Dysbiosis Clinical Trials

Safety and Efficacy of FMT in Individuals With One or More Recurrences of Clostridium Difficile Associated Disease (CDAD)

Start date: January 11, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

Multi-center, randomized, placebo controlled, partially blinded trial comparing the safety and efficacy of fecal microbiota transplantation versus placebo both delivered by rectal enema in subjects 18 years of age or older with recurrent Clostridium difficile Associated Disease (CDAD). 162 male or female subjects will be enrolled in the study. Enrolled subjects will be randomized at each site to receive either FMT by enema or placebo by enema in a 2:1 ratio. Study duration is 3 years, subject participation duration is approximately 1 year. The primary study objectives are: 1) to evaluate the safety of FMT(s) delivered by enema vs. placebo delivered by enema and 2) to determine efficacy of FMT delivered by enema vs. placebo delivered by enema.

NCT ID: NCT03545243 Completed - Dysbiosis Clinical Trials

PPI and Microbiome in Healthy Volunteers and Functional Dyspepsia

Start date: April 23, 2018
Phase: Phase 4
Study type: Interventional

Prospective interventional study of the effect of PPI on the duodenal microbiome in healthy volunteers and functional dyspepsia patients

NCT ID: NCT03523403 Completed - Inflammation Clinical Trials

Obesity-related Health Benefits of Apples

Start date: October 12, 2017
Phase: N/A
Study type: Interventional

Obesity is characterized by an underlying inflammatory state in which various inflammatory signaling molecules, termed cytokines, affect metabolic processes central to type 2 diabetes and cardiovascular disease; leading causes of disability and death in Ontario. Such obesity-associated inflammation is partly due to the movement of endotoxin (i.e. lipopolysaccharide (LPS), a cell wall component of Gram-negative bacteria) from the gut microbiota to the blood, resulting in elevated blood levels of LPS (a condition termed metabolic endotoxemia) that stimulates inflammation. Digestion of a high-fat meal increases blood LPS and is subsequently associated with inflammation and metabolic impairments. However, in this context, little is known about how the consumption of bioactive-rich foods, such as whole apples, can improve impaired inflammatory and metabolic responses in overweight and obese individuals. Apples are a key commodity to study given that they are Ontario's predominant fruit crop with the apple industry valued at approximately $400 million, they require little food preparation, and they are common in the diet year-round. There are some, but limited, reports of potential apple-induced health benefits related to reductions in inflammation and improved metabolic responses in lean/healthy individuals, but work in overweight and obese individuals is especially lacking. Thus, to address the gap in our understanding of how daily apple intake may improve the health consequences of obesity, we will conduct a randomized clinical trial in which overweight and obese adults will consume three Ontario-grown Gala apples (approximately 300 g) as part of their typical diet in one sitting (i.e. acute consumption) and/or daily for six weeks (i.e. chronic consumption). The Acute Apple Consumption phase of the study will follow a randomized crossover design in which participants' rate of gastric emptying, efficacy of dietary lipid digestion and absorption, and production of inflammatory cytokines and biomarkers of metabolism will be assessed before and after consuming a high-fat meal (designed to provide 1 g fat/kg body weight) with or without three apples in one sitting. The Chronic Apple Consumption phase of the study will follow a randomized, controlled, parallel-arm design in which participants' (fasting) production of inflammatory cytokines and biomarkers of metabolism, as well as their gut microbiota profile, will be assessed before and after consuming three apples (or no apples) daily for six weeks. We hypothesize that the consumption of three whole apples in one sitting and daily for six weeks will improve these parameters in overweight and obese individuals at risk of developing chronic metabolic diseases.

NCT ID: NCT03414775 Recruiting - Critical Illness Clinical Trials

Influences of High-fiber, Organic Whole-food Formula on the Gut Microbiome in Critically Ill Children

Start date: February 2, 2018
Phase: N/A
Study type: Interventional

This study evaluates the effects of either Pediasure or Nourish formulas on the gastrointestinal microbiome in critically-ill children. Patients will be randomized to received either Pediasure or Nourish.

NCT ID: NCT03265639 Completed - Clinical trials for End Stage Renal Disease

Prebiotics in Peritoneal Dialysis

Start date: April 21, 2016
Phase: N/A
Study type: Interventional

The Prebiotics in Peritoneal Dialysis trial is a non-randomized, open-label, crossover study of p-inulin for patients with end-stage renal disease treated with peritoneal dialysis.

NCT ID: NCT03234452 Completed - Stress Clinical Trials

Evaluation of the Beneficial Effects of a Probiotic Product in Healthy Adult Subjects.

Start date: March 23, 2016
Phase: N/A
Study type: Interventional

A randomized, double-blind, placebo-controlled, cross-over trial performed at one centre in Italy to explore the ability of a multistrain probiotic mixture, to modulate markers of inflammation and intestinal barrier function and gastrointestinal symptoms in healthy volunteers with self-reported anxiety.

NCT ID: NCT03225950 Completed - Clinical trials for Rheumatoid Arthritis

Interaction Between Immune Cells and Bacteria Associated With Periodontitis

Start date: February 1, 2017
Phase:
Study type: Observational

This study evaluates the interaction between host immune cells and bacteria associated with periodontitis. It comprises biological material from donors with and without periodontal disease. Specifically, we collect a spit and blood sample to conduct in vitro stimulations and measurements of selected parameters related to periodontitis to clarify obscure areas in the immunologic pathogenesis of this disease.

NCT ID: NCT03163784 Withdrawn - Inflammation Clinical Trials

SHIFT: Studying HIV Immunology After Fecal Transplant

SHIFT
Start date: June 2018
Phase: Phase 1/Phase 2
Study type: Interventional

SHIFT is a randomized, longitudinal, prospective, blinded, three-arm study to determine the safety and tolerability of Fecal Microbiota Transplant (FMT) in HIV-infected participants on stable antiretroviral therapy (ART).

NCT ID: NCT03127176 Completed - Bipolar Disorder Clinical Trials

Dysbiosis in Bipolar Disorder

MOB
Start date: October 1, 2019
Phase:
Study type: Observational

The gut microbiota is a complex community comprising around 10^14 bacteria that live in the gut lumen. The imbalance of the normal structure and function of the microbiota, defined as dysbiosis, has been related to a wide diversity of pathologies, including mental health disorders. However, clinical evidence of the relationship between microbiota and mood disorders is lacking. The aim of this project is to examine the possible relationship of gut dysbiosis and the diagnosis of bipolar disorder (BD), of gut dysbiosis and mood relapses and of gut dysbiosis and cognitive impairment in bipolar patients.