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Microbiome clinical trials

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NCT ID: NCT05144282 Enrolling by invitation - Clinical trials for Retinopathy of Prematurity

The Analysis of Association of Retinopathy of Prematurity, Gut Microbiome Profile, and Systemic Inflammation

Start date: August 15, 2020
Phase:
Study type: Observational [Patient Registry]

Study Aims 1. Understanding the gut microbiome profile in very low birth weight infants with or without ROP. The onset and aggravation of ROP and their relationship with gut microbiome will be examined. 2. Understanding the serum inflammatory cytokine profile in these infants and its relationship with the onset and progression of ROP. Their changes and association with the other systemic disorders such as NEC or RDS or sepsis will be explored. 3. Examiningthe associations amongmicrobiome profile and serum inflammatory cytokines and their relationship with ROP clinical features (prematurity without ROP, ROP without treatment, and ROP with treatment) in the study participant

NCT ID: NCT05123612 Active, not recruiting - Inflammation Clinical Trials

Maternal & Offspring Microbiome Study

MOMS
Start date: January 12, 2022
Phase: N/A
Study type: Interventional

The purpose of the study is to learn how different dietary interventions affect microbiota diversity in pregnant women and the transmission of microbiota to their infants during pregnancy, birth, and postpartum.

NCT ID: NCT05015530 Recruiting - Microbiome Clinical Trials

Impact of Symbiofilm On Nasal Microbiota

ISONAM
Start date: December 12, 2022
Phase:
Study type: Observational

Healsea® chronic is CE marked medical device indicated in adults for the treatment of nasal symptoms of chronic rhinosinusitis. This is an hypertonic seawater-based nasal spray supplemented with natural Symbiofilm® extract (0.2%) isolated from marine bacteria. In vitro, Symbiofilm® inhibits at early stage biofilm formation from bacteria found to be more prevalent and abundant in CRS patients (e.g. Staphylococcus aureus, Pseudomonas aeruginosa). This exploratory study is designed with aim to determine if the antibiofilm properties of Symbiofilm® may modify sino-nasal microbiota, impacting α and/ or β diversities.

NCT ID: NCT05007470 Recruiting - Clinical trials for Alcohol Use Disorder

Alcoholic Liver Disease and the Gut Microbiome

Start date: January 31, 2022
Phase: N/A
Study type: Interventional

Background: Significant sex differences exist in regard to alcohol use disorder (AUD) and alcoholic liver disease (ALD). To date, no studies have examined the brain-gut-microbiome (BGM) axis (which is the relationship between the gut, brain, and the bacteria within the gut) and sex-differences in AUD and ALD. Aims: 1) Demonstrate baseline sex differences in the microbiome and metatranscriptome of AUD and ALD and correlate those differences to severity, 2) determine if these baseline sex differences predicts abstinence or ALD related outcomes, and 3) show how altering the microbiome can decrease the severity of AUD and ALD in a sexdependent manner. Hypothesis: Our project is aimed to explore the hypothesis that sex-related differences of the BGM axis in AUD and ALD explains the variation in patient severity and outcome by sex, and that alterations of the BGM axis can decrease the severity of AUD and ALD in a sex-dependent manner. Methods: A pilot randomized placebo (VSL#3 vs placebo) control trial will be performed in patients with AUD and ALD for 6 months. Questionnaire data, clinical labs, serum, and feces for shotgun metagenomics will be collected at baseline, 3-months, and 6-months. Anticipated Results: Patients with severe AUD/ALD will have more microbes and microbial genes associated with inflammation. These differences will predict outcomes at 6-months and that changes of this baseline microbiome with VSL#3 will lead to more positive outcomes than placebo, with men having greater benefit from VSL#3 than women. Implications and Future Studies: The discovery of the mechanisms underlying sex-related differences in AUD/ALD is needed for the development of personalized recommendations for prevention and treatment in men and women

NCT ID: NCT04970446 Recruiting - Crohn Disease Clinical Trials

Microbial Restoration in Inflammatory Bowel Diseases

MIRO II
Start date: December 1, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

This is a prospective, two-centre, double-blind, parallel-arm, randomised, placebo-controlled trial evaluating the impact of FMT on patients with active Crohn's disease.

NCT ID: NCT04865861 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

The Characteristic of Airway Microbiome Profiling of COPD-bronchiectasis Overlap Patients and Its Association With Acute Exacerbation

Start date: May 1, 2021
Phase:
Study type: Observational [Patient Registry]

The overlap between chronic obstructive pulmonary disease (COPD) and bronchiectasis is a neglected area of research, and it is not covered by guidelines for clinical practice. COPD and bronchiectasis share common symptoms of cough with sputum production and susceptibility to recurrent exacerbations driven by new or persistent infection. Physiological criteria for the diagnosis of COPD and structural criteria for the diagnosis of bronchiectasis create the possibility for individual patients to fulfil both, resulting conceptually in either co-diagnosis or an overlap syndrome between the two conditions. The prevalence of this overlap will vary depending on the respective prevalence of COPD and bronchiectasis in the population under consideration. A recent study of 201 COPD patients with airway wall abnormalities typical of bronchiectasis confirmed an association with exacerbations and was predictive of mortality over 48 months. A further, single-centre study demonstrated a near three-fold increased mortality rate, with patients with bronchiectasis and associated COPD having a 5-year mortality of 55%, compared with 20% in those with bronchiectasis without COPD. Airflow obstruction is perhaps best considered one marker of disease severity in bronchiectasis. Disease-associated exacerbations have a major effect on patient healthcare costs as well as quality of life due to increased lung damage and mortality risk. Microorganisms such as Pseudomonas aeruginosa and, to a lesser extent, other Gram-negative and Gram-positive microorganisms identified in culture, have been linked to disease progression, poor clinical outcomes in bronchiectasis and driving airway neutrophil-mediated inflammation. The microbiome has the potential to provide valuable information regarding disease phenotype/endotype, treatment responses and targets for future therapy.

NCT ID: NCT04851340 Completed - Stress Clinical Trials

Investigating the Detection of Bovine and Soy Proteins in Human Milk

Start date: November 9, 2020
Phase: N/A
Study type: Interventional

This study is a randomized, cross-over, dietary intervention research design comprising a 5-day run-in period, two 3-day dietary interventions, and a 7-day washout period. Participants (mother-offspring dyads) will be randomly assigned to order of interventions. Participants will be recruited as a convenience sample from mother-offspring dyads in the greater Moscow, Idaho and Boise, Idaho areas. The purpose of this study is to to learn more about the use of an allergen test strip to detect cow's milk and soy food allergen proteins in human milk, to explore the impact of maternal bovine milk and soy milk consumption on human milk and maternal/infant gastrointestinal microbiomes and to examine maternal stress during periods of dietary elimination and re-introductions periods.

NCT ID: NCT04611945 Completed - Mood Clinical Trials

Westlake Sailing Cohort

Start date: November 10, 2020
Phase:
Study type: Observational

Little is known about the dynamic change of human microbiome in different body sites including skin, mouth and gut during sailing. The present study aims to reveal the change of human microbiome in response to the sailing environment in a 1-month period, and its implication for human health.

NCT ID: NCT04552834 Active, not recruiting - Critical Illness Clinical Trials

Alterations of the Microbiome During Critical Illness With Short and Long Term Clinical Outcomes

Start date: September 15, 2020
Phase:
Study type: Observational

This study is designed to study the variations in the microbiome among critically ill patients and the effect of admission to the medical intensive care unit (MICU) at the University of Chicago. Additionally, investigators will examine the downstream clinical effects of dysbiosis in ICU patients and how patients maybe effected long term.

NCT ID: NCT04399252 Completed - Microbiome Clinical Trials

Effect of Lactobacillus on the Microbiome of Household Contacts Exposed to COVID-19

Start date: June 24, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the effect of the probiotic Lactobacillus rhamnosus GG (LGG) and the effect of COVID-19 on the microbiome (the microorganisms that live in and on the human body) in exposed household contacts of COVID-19. This is a randomized, double-blind, placebo-controlled study, meaning subjects will be randomly assigned to receive LGG or a placebo (an inactive substance given in the same form as the active substance) and will not know which product they are receiving. Subjects will participate in the study for around 60 days. All subjects must refrain from taking any other probiotics while on study. All subjects must have access to e-mail and the internet to complete study questionnaires. Participation in this study entails taking LGG/placebo for 28 days, responding to questionnaires, and providing stool and nasal swab samples.