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Microbial Colonization clinical trials

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NCT ID: NCT05840081 Recruiting - Inflammation Clinical Trials

Dairy Fat and Fermentation Study

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

The purpose of the study is to compare the effect of consuming full-fat (regular) and fat-free (skim) milk, as well as full-fat and fat-free yogurt (a fermented dairy product), on microorganisms in your gut as well as the products produced by the gut microbes. We will also determine whether consuming these dairy products affects risk factors for heart disease.The findings of the study will help us determine if heart disease risk factors are modified by the fat content and fermentation of milk. The results may facilitate refinement of public health dietary guidance for cardiovascular disease risk reduction.

NCT ID: NCT05815433 Recruiting - Clinical trials for Microbial Colonization

Comparing Impacts of Donor Human Milk to Formula Supplementation on the Gut Microbiome of Full-term Infants

PPDHM
Start date: July 1, 2023
Phase: N/A
Study type: Interventional

The goal of this pilot randomized controlled trial (RCT) is to examine donor human milk (DHM) as a clinical intervention targeted at achieving beneficial microbiome signatures in full-term infants who are exposed to intrapartum antibiotic prophylaxis (IAP) therapy during labour. Secondarily, this study aims to compare the infant health outcomes of sleep and growth between groups to assess if these outcomes are mediated by infant feeding type or potential differences in microbial signatures. Finally, this study will compare maternal outcomes of depression, anger, breastfeeding self-efficacy and breastfeeding rates between groups. The hypothesis of this study is: that replacing formula with DHM supplementation will minimize gut microbiome dysbiosis and foster homeostasis following supplementation. In addition, it is hypothesized that improved homeostasis will promote improved sleep and growth outcomes in participant infants. Finally, mothers whose infants receive DHM will have lower depression and anger scores and high breastfeeding self-efficacy and exclusive breastfeeding rates compared to mothers whose infants receive formula.

NCT ID: NCT05779254 Recruiting - Clinical trials for Microbial Colonization

SURGIcal COmplication and MIcrobiome ChangeS in Colorectal Surgery

Surgi-Comics
Start date: February 1, 2023
Phase:
Study type: Observational

The microbiome, the collection of microorganisms that live in our gut, plays an important role in maintaining our health, proper nutrient absorption, nutrient turnover and immunity. After birth, a symbiotic relationship develops with the strains of bacteria that colonise our gut, and the presence and proportion of bacteria is individualised and highly variable. A healthy bacterial flora is essential for the cells of the intestinal mucosa. Glycoproteins in the cell surface mucus coat are important nutrients for bacteria, while some bacterial strains supply mucosal cells with nutrient molecules (e.g. short-chain fatty acids) that are their essential energy source. An abnormal change in the proportion of bacterial strains that make up the microbiome, dysbacteriosis, in which pathogenic bacteria proliferate at the expense of members of the normal flora, can cause a number of pathologies. Nutrient supply to the cells of the mucosa is reduced, making them more vulnerable and leading to various pathological conditions. The microbiome and the essential nutrients they produce have also been found to play an important role in wound healing. A decrease in the diversity of the microbiome, an increase in the relative number of pathogenic bacteria and a decrease in the proportion of 'beneficial' bacteria increases the risk of surgical complications of infection and suture failure.

NCT ID: NCT05765422 Recruiting - Clinical trials for Microbial Colonization

The Influence of Endurance Sports Activity on the Oral Microbiota of Young Adults.

ORAMICAP
Start date: October 17, 2022
Phase: N/A
Study type: Interventional

The oral cavity is an easily accessible anatomical site that accurately reflects the health of the individual. The mouth is considered an early indicator of biological aging, leading to the identification of oral biomarkers predictive of future alterations. Current data show that the oral health of high level athletes is globally altered with an increase in cariogenic indexes, an increased incidence of periodontitis, dental trauma and dry mouth syndromes. Few studies have focused on the oral microbiota compared to mouthguards used in rugby or boxing which seem to induce dysbiosis, a recent study shows an effect of ketogenic diet on bacterial changes in the mouth of endurance athletes. This project focuses on the impact of intensive sport practice on oral health and the identification of oral biomarkers associated with physical activity. The objective of this study is to investigate the impact of the amount of endurance sport practice on oral microbiota and oral health in young adults. the hypothesis is that a sedentary lifestyle and high-level sport induce depletion and/or changes in the oral microbiota compared to regular physical activity.

NCT ID: NCT05763680 Recruiting - Clinical trials for Microbial Colonization

Molecular Culture for the Diagnosis of Neonatal Sepsis

Start date: July 15, 2023
Phase:
Study type: Observational

Rationale: Early diagnosis of sepsis in neonates is complicated as the signs and symptoms are nonspecific. Although blood culture is the gold standard for the diagnosis, false-negative results and long incubation period of 36-72 hours limits the use of blood culture to rule out sepsis at initial suspicion. Since delay in diagnosis may lead to progressive deterioration, antibiotics are often started empirically at initial sepsis suspicion, awaiting results of the blood culture. Consequently, uninfected infants are often unnecessarily exposed to empirical antibiotics. To reduce unnecessary treatment of non-infected infants, an early, sensitive and specific diagnostic tool would be helpful to guide clinicians faster when to discontinue antibiotics. Molecular Culture (MC) via IS-pro is a novel, advanced, molecular culture technique which is able to culture bacteria within 4 hours after blood sampling. MC might thus be a potential diagnostic tool to detect or rule out sepsis in infants quickly, however data on MC for diagnosis of sepsis in this population is limited. Objective: The aim of this study is to evaluate whether MC is of additive predictive value for the diagnosis sepsis in this vulnerable group. Study design: Prospective observational cohort study. Study population: All infants suspected for neonatal sepsis of both early and late onset will be eligible for study participation. They will be treated according to the standard local guidelines. Intervention (if applicable): In case of a suspicion of sepsis at birth, blood will be collected for a conventional blood culture as part of standard care. Additionally, a blood sample will be collected from the umbilical cord for MC. In case of a suspicion of sepsis not directly postpartum, an additional blood sample will be taken for MC analysis, directly following sampling for conventional culture, implying no extra phlebotomy. Main study parameters/endpoints: The main study parameter is the discordance in positive and negative outcomes of MC compared to outcomes of conventional blood culture. As the diagnostic accuracy of the conventional blood culture (the current gold standard) is being questioned, the predictive value of MC versus conventional blood culture towards clinical sepsis will also be tested.

NCT ID: NCT05750381 Recruiting - Clinical trials for Microbial Colonization

Assessment of Colonisation and Skin Quality Parameter Improvement by Probiotic Micrococcus Luteus Q24 Balm in Healthy Adults.

Start date: January 24, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the skin quality improvement and colonization efficacy following the application of probiotic Micrococcus luteus Q24 (BLIS Q24) to the elbow and back of forearm in a topical balm format in healthy adults.

NCT ID: NCT05748795 Recruiting - Clinical trials for Microbial Colonization

Microbial Colonization in Lung Cancer Patients

Start date: February 1, 2023
Phase:
Study type: Observational [Patient Registry]

Primary Aim: -To determine the prevalence and pattern of bronchial colonization in patients presenting with lung cancer at the time of diagnosis Secondary Aim: -To assess the potential demographic, clinical, radiological and histological predictors of colonization in patients with lung cancer

NCT ID: NCT05743374 Recruiting - Ulcerative Colitis Clinical Trials

Micronutrient and Additive Modifications May Optimize Diet To Health

Mammoth
Start date: April 2, 2024
Phase: N/A
Study type: Interventional

This is a prospective clinical intervention trial where patients with moderately active ulcerative colitis are randomized to either normal healthy diet or a diet with elimination of emulsifying agents within the E 400-group with special respect to carragenan, CMC and polysorbates. At study start and end after one month their diet, clinical characteristics and microbiota will be analysed. The hypotheses are that their disease activity measured with calprotectin and their microbiota will improve after intervention.

NCT ID: NCT05695196 Recruiting - Clinical trials for Microbial Colonization

Feasibility and Safety Study of Parent-to-Child Nasal Microbiota Transplant

ParentsTREAT
Start date: October 25, 2023
Phase: Phase 1
Study type: Interventional

This feasibility and safety pilot study looks to determine whether transferring a parents healthy, diverse nasal microbiota to the participant's infant(s) will create a healthy, diverse neonatal nasal microbiome.

NCT ID: NCT05669690 Recruiting - Clinical trials for Microbial Colonization

Storage Conditions and Breast Milk Microbiota Composition

Start date: May 12, 2023
Phase:
Study type: Observational

Breast milk is the mainstay of newborn nutrition, providing all the nutrients and vitamins necessary for optimal growth of newborn infants. Beside its nutritional properties, breast milk also contains bioactive factors such as soluble immune factors, antimicrobial proteins, functional fatty acids, hormones, oligosaccharides, stem cells and microbiota. Although fresh breast milk is the optimal source of nutrition for newborn infants, breast milk must be expressed and stored in some conditions. Breast milk was thought to be sterile for many years. This idea has changed with the isolation of live bacteria in the breast milk of healthy mothers in the recent past. Thus, it has been shown that breast milk is not actually a sterile body fluid, but has a microbiota of its own. This study aimed to examine the effect of storage conditions of breast milk at different temperatures on the microbial composition of the breast milk. The prospective experimental study will be conducted under the supervision of Istanbul University, Istanbul Medical Faculty, Department of Pediatrics, Neonatology Department. Informed consent of mothers will be taken. Thirty mililiter (30 mL) breast milk that was obtained from volunteer mothers will be divided into 3 samples, each 10 mL of breast milk will be stored at different temperatures. Ten mililiter will be studied for microbial composition with 16S rRNA amplicon sequencing and bioinformatics analysis immediately, 10 mL will be stored at +4'C for 3 days and will be studied at the end of 3rd day, other 10 mL will be stored at -20'C for 3 months and will be studied at the end of 3rd months. 16S rRNA amplicon sequencing and bioinformatic analysis studies will be performed at Istanbul Medical Faculty Clinical Nutrition and Microbiota Research Laboratory. This present study is planned to be carried out for 24 months between January 2023 and December 2024