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Human Microbiome clinical trials

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NCT ID: NCT03907501 Terminated - Human Microbiome Clinical Trials

Effects of Triphala and VSL#3 Probiotic Supplementation on Stool Microbiome Profiles and Inflammation

TRIPH2017
Start date: February 1, 2019
Phase: N/A
Study type: Interventional

Normal aging can lead to loss of gut microbial biodiversity which is linked to inflammaging and immunosenescence or the loss of immunocompetence. Probiotics, such as VSL#3®, and certain herbal supplements such as Triphala are associated with restoration of gut community architecture, increased gut barrier function and decreased inflammation. The present project will examine the potential benefits of a synbiotic (which denotes a prebiotic plus probiotic, and in this study, is an herbal prebiotic plus probiotic) intervention (8 weeks of supplementation) on gut microbiome profiles assessed via stool, inflammatory blood markers, and questionnaires about gastrointestinal health and mood. In this exploratory study, the investigators will examine psychological and physical functioning at baseline and after 8 weeks of supplementation with synbiotic, Triphala alone, or placebo.

NCT ID: NCT03809260 Completed - Human Microbiome Clinical Trials

A Clinical Trial for Analysis of Intestinal Microbiome Affecting PK, PD, and Safety of Metformin

Start date: December 1, 2018
Phase: N/A
Study type: Interventional

This clinical trial is intended to evaluate the effects of the changes in intestinal microbiome by antibiotics (PO vancomycin) on the pharmacokinetic /pharmacodynamic and safety profiles of metformin in healthy male volunteers.

NCT ID: NCT03668015 Completed - Human Microbiome Clinical Trials

Xylitol and Sorbitol Effects on the Oral Microbiome

Start date: March 5, 2015
Phase: N/A
Study type: Interventional

Chewing gum containing xylitol may help prevent caries by reducing levels of mutans streptococci (MS) and lactobacilli in saliva and plaque. Very little is known about other species which are possibly beneficial to oral health. In this study, the investigators employed high-throughput sequencing of the 16S ribosomal ribonucleic acid (rRNA) gene to profile microbial communities of saliva and plaque following short-term consumption of xylitol and sorbitol containing chewing gum. Participants (n = 30) underwent a washout period and were randomly assigned to one of two groups. Each group chewed either xylitol or sorbitol gum for 3 weeks, before undergoing a second four-week washout period after which they switched to the alternate gum for three weeks.

NCT ID: NCT03581812 Completed - Eating Behavior Clinical Trials

Snack Foods and Their Impact on Gastrointestinal Microbiology, Function and Symptoms

OptiGut
Start date: April 27, 2018
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the impact of replacing usual snacks with alternative snack foods on gut health in a population of habitual snackers with low fibre intake.

NCT ID: NCT03543605 Completed - Clinical trials for Antibiotic Resistant Infection

Clinical/Microbiological Impact of a Specific Antimicrobial Stewardship Program for Nursing Homes

PROA-SENIOR
Start date: July 1, 2018
Phase: N/A
Study type: Interventional

Background: In nursing homes, excessive and inappropriate use of antimicrobials, adverse events caused by these drugs, and infections by multidrug-resistant bacteria (MDRB) are more frequent than in the general population, posing a serious Public Health risk. Antimicrobial stewardship programs (ASP) are a key strategy to improve the use of antibiotics and to fight against bacterial resistance. Its usefulness in hospitals has been demonstrated. The Centers for Disease Control and Prevention urge the implementation ASP in nursing homes, with measures taken from the ASP in hospitals, but the available information is so limited that it does not allow specific recommendations to be made for these centers. Objectives: To know if an ASP with an individual intervention measure, the clinical assessments, is better to an ASP with general intervention measures, both designed specifically for nursing homes, and what is the clinical and ecological impact of both, on the baseline situation. Methods: a) Randomized clinical trial, in parallel groups, for comparison of both ASP. b) Quasi-Experimental study of timeseries for the evaluation of the clinical and ecological impact on the baseline situation. The following indicators will be analyzed: the use of antimicrobials in the centers; the intestinal microbiota diversity of nursing home residents, and the incidence of MDRB and Clostridium difficile infections; and the frequency of adverse events caused by antimicrobials and hospital admissions for infections. The study population will be 2.220 residents from 20 public nursing homes.

NCT ID: NCT03231332 Enrolling by invitation - Human Microbiome Clinical Trials

Effects of H.Pylori Eradication on Microbiome

Start date: July 29, 2017
Phase: Phase 4
Study type: Interventional

The aim of this Project is, within the scope of industrial research, to evaluate the long term effects of H.pylori eradication on microbiome (gut microbiome, upper respiratory tract microbiome) and lasting adverse events. In addition, the project aims to evaluate its effects on abundance and prevalence of extended-spectrum beta-lactamases coding genes and develop cost effective ESBL screening test prototype.

NCT ID: NCT03181269 Completed - Breast Feeding Clinical Trials

Human Milk and Infant Intestinal Microbiome Study

Start date: July 27, 2017
Phase: N/A
Study type: Interventional

This study will explore the effects of skin-to-skin contact (SSC) between mothers and their babies on the infant intestinal microbiome, the maternal skin microbiome and the breast milk microbiome. This will be accomplished by administering an intervention education session to one group and a placebo education session to the second group in order to influence the magnitude of total SSC defined by the frequency and duration of contact time between the two groups.

NCT ID: NCT03157687 Completed - Human Microbiome Clinical Trials

Detection of Luminal and Mucosa-associated Microbiome in Healthy Controls vs. Local and Systemic Inflammation

Start date: June 2016
Phase:
Study type: Observational

This study should reveal differences in composition of luminal and mucosa-associated microbiome of the human gastrointestinal tract.Therefore bacterial species of different intestinal location sites (small intestine and colon) isolated of biopsies were compared to bacterial composition of stool samples. Additionally the bacterial composition of healthy persons, patients with inflammatory bowel disease and with liver disease (liver cirrhosis) will be compared to detect influence of local and systemic inflammation on microbiome.

NCT ID: NCT02731976 Completed - Human Microbiome Clinical Trials

Microbiome Composition Changes on 4 Week Gluten-free Diet Challenge

Start date: November 2011
Phase: N/A
Study type: Interventional

Changes in the gut microbiomes of healthy volunteers who followed a gluten-free diet (GFD) for four weeks were studied. Per participant, nine stool samples were collected: one at baseline, four during the GFD period, and four when they returned to their habitual diet. Microbiome profiles were determined using 16S rRNA sequencing and the samples were next processed for taxonomic and imputed functional composition. Additionally, participants kept a 3-day food diary and six gut health-related biomarkers were measured.

NCT ID: NCT02407184 Withdrawn - Human Microbiome Clinical Trials

Potential Restoration of the Infant Microbiome

PRIME
Start date: April 2015
Phase: N/A
Study type: Interventional

Understanding the microbiome's important role in human health, the investigators wish to determine how the development of the infant microbiome is impacted by delivery mode, comparing natural vaginal birth to scheduled C-sections. Investigators will look at the oral, nasal, skin, vaginal and fecal bacteria of 78 mothers and their infants from birth to age 1.