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Gut Microbiome clinical trials

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NCT ID: NCT03967990 Completed - Gut Microbiome Clinical Trials

Corn and Heart Health Study

CHS
Start date: March 20, 2018
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate the effects of 3 different corn flours: (1) whole grain corn flour, (2) 50% refined corn flour + 50% corn bran derived from whole corn meal, and (3) refined corn flour, on cardio-metabolic outcomes and changes in the gut microbiome.

NCT ID: NCT03797417 Recruiting - Gut Microbiome Clinical Trials

Gut Microbiome and Metabolic Pathways Changes in Vitiligo

Start date: September 18, 2018
Phase:
Study type: Observational

Vitiligo is a chronic depigmenting autoimmune-associated skin disease and a growing psychological health concern because of its low quality of life. Genetics, immunology and environment triggers contribute to the pathophysiology of vitiligo. Identify and decrease the risk factors of vitiligo is very crucial for vitiligo treatment and prevention. Emerging evidence has linked gut microbiome to human autoimmune diseases. Here the investigators will analyze 10,913 metagenomes in stool samples from 100 adult vitiligo patients and gut microbiome associated metabolites in patients serum.

NCT ID: NCT03605108 Completed - Gut Microbiome Clinical Trials

The Influence of Oral Probiotics on the Microbiome and Lipidome

Start date: June 29, 2018
Phase: N/A
Study type: Interventional

The purpose of this study is to measure oil production of the face, facial properties, and gut bacteria in people being given oral probiotics. Probiotic supplements contain active cultures of bacteria that are thought to be beneficial to human health.The investigators want to find out if probiotics taken by mouth alter the bacteria in subject's gut and subject's skin oil production compared to a placebo. This is a single blind study and subject may receive a probiotic or a placebo for the first half of the study and a placebo or a probiotic for the second half of the study. Subject will not know what was given to participants.

NCT ID: NCT03601936 Terminated - Gut Microbiome Clinical Trials

User Testing of the Evivo Screening Test

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

The study is an evaluation of the Evivo Screening Test's ability to differentiate between high and low levels of Bifidobacterium in infant stool specimens.

NCT ID: NCT03476447 Completed - Gut Microbiome Clinical Trials

Rescuing the Microbiome Effectively With Different Doses of B. Infantis in Infants

REMEDI
Start date: April 6, 2018
Phase: N/A
Study type: Interventional

The REMEDI Study is a single-center, prospective, double-blind, randomized, placebo-controlled trial of multiple doses of B. infantis EVC001 supplementation in healthy term breastfed infants.

NCT ID: NCT03373721 Recruiting - Preterm Infant Clinical Trials

Gut Microbiota of Preterm Infants and Full-term Infants at Early Life

Start date: July 20, 2014
Phase:
Study type: Observational

The aim of this study is to obtain a longitudinal view of the gut microbial establishment of a cohort of 51 preterm (PT) infants compared to 50 full-term (FT) infants from birth to 90 days of age, and to identify key clinical factors that affect the establishment of neonatal microbiome. The hypothesis of the investigators is that the gut microbiota progression of PT group and FT group is different in diversity and composition. Antibiotics and its usage duration is likely the main factor disturbing the colonization and development of the gut microbiome of PT infants.

NCT ID: NCT03325855 Recruiting - Clinical trials for Clostridium Difficile Infection

Fecal Microbiota Transplant National Registry

FMT
Start date: September 20, 2017
Phase:
Study type: Observational [Patient Registry]

A national data registry of patients receiving fecal microbiota transplantation (FMT) or other gut-related-microbiota products designed to prospectively assess short and long-term safety and effectiveness

NCT ID: NCT03219931 Completed - Gut Microbiome Clinical Trials

NEOBIFI: Clinical Trial for the Prevention and/or Reduction of the Incidence of Colics in Infants

NEOBIFI
Start date: October 1, 2013
Phase: Phase 4
Study type: Interventional

Infant colics represent a clinical condition in childhood, characterized by an uncontrollable crying that occurs without any apparent organic cause.1 They can be associated with face redness, closed fists, thighs flexion, meteorism, and gas emission. They are generally diagnosed according to Wessel's "rule of three" (>3 h of crying a day, for >3d a week, for >3wk in a row).2 These crises tend to reach their maximum intensity at 6 weeks of age, in most cases.3 They represent a serious source of anxiety for the family, increasing hospital admissions (5.8% of infants),4 postpartum depression risk, with higher stress levels for up to 3 years from these events. The etiology is still unknown. Anyway, it's assumed that the following factors may be involved: (1) Lactose intolerance. (2) Food hypersensitivity. (3) Feeding difficulties. (4) Disorders of the enteric nervous system. (5) Alterations of pain transmission. (6) Gastroesophageal reflux. (7) Intestinal hormones. (8) Psychosocial factors. (9) Alteration of the intestinal microbiota. In 1994, Lehtonen was the first to suggest that an altered intestinal microbiota composition in the very first months may induce intestinal colics in infants. Human intestinal microbiota is composed of about 1013 to 1014 microorganisms, mainly bacteria. The total number of microbiota genes is called "microbioma" and it is estimated to be 150 times the number of genes in the human genome.5 It acts as a real organ, whose activity can be influenced by diet, lifestyle, prebiotics, probiotics, and antibiotics. Several studies revealed the predominance of bifidobacteria in breastfed infants, whereas bottle-fed infants show a mixed population where bifidobacteria are less represented. the intestinal microbiota composition in a 3-year-old child is already similar to that of an adult.6 Other factors conditioning the microbiota are gestational age and type of birth. Colicky infants have a microbiota with a slow development and a lower stability over time.7 It also contains less lactobacilli and bifidobacteria, and a prevalence of gram-negative bacteria. The stools of these children often show increased levels of calprotectin, an intestinal index of inflammation. RISK FACTORS ARE SEVERAL: Smoking: The exposure to cigarette smoke may be related to colics; this might be connected to the increase of plasma and intestinal levels of motilin. Maternal smoking during pregnancy seems to increase the risk of developing colics, more than postnatal exposition to smoke.8 Psychosocial: Infant colics may be more frequent with an instable psychosocial family environment. Maternal stress, anxiety, and depression are important risk factors.8 Breastfeeding: The difference between breastfeeding and bottlefeeding for colicky infants is controversial. Many studies have shown contrasting results,17 but the majority of the authors agree to attribute an important role to bottlefeeding. 9 A melatonin role was assumed too. This hormone is not secreted in infants, but only in adults, and has a hypnotic and relaxing role on the gastrointestinal smooth muscle. Its concentration shows a clear circadian rhythm, with a pick during night hours. Its presence in breast milk may be related to the lower occurrence of colics in breastfed infants compared with the bottle-fed infants.9 Recent literature shows an increasing attention toward probiotics,10 for the intestinal microbiota modulation. Some Lactobacillus reuteri strains were studied, with contrasting results in different studies; other probiotics as bifidobacteria showed in vitro anti-inflammatory properties and the ability to inhibit coliforms growth, whose presence is significant in colicky infants. Some probiotics exert a direct action on the bacterial growth, through bacteriocins production and final fermentation products.11 Bifidobacterium breve was isolated from healthy infants' feces.12 Aloisio et al13 tested in vitro ability of this strain and of other 45 bifidobacteria strains to oppose the growth of several microorganisms such as E. coli, S. enteriditis, C. difficile, K. pneumoniae, and Enterobacter cloacae. B. breve BR03, in a randomized clinical study, proved to have a beneficial effect on constipation in adults, it also seemed effective for the reduction of gas formation and for abdominal distension, and no side effects were shown during the treatment, while the beneficial effects lasted for up to 15 days after the end of the treatment.14,15 Both bifidobacteria strains showed, during an in vitro study, the ability to oppose 4 strains of E. coli; in particular, BR03 displayed an activity against E. coli O157:H7, an enterohemorrhagic strain that through Shiga toxin causes a potentially lethal infection.16

NCT ID: NCT03218579 Recruiting - Gut Microbiome Clinical Trials

Endoscopic Assessment and Prediction of Microbiome-modifying Interventions

microbiome
Start date: February 1, 2013
Phase: N/A
Study type: Interventional

The investigators would like to examine the extent of gut microbiome rehabilitation in healthy people after the consumption of antibiotics. Outcomes of probiotic treatment versus bacteriotherapy will be compared.

NCT ID: NCT03058575 Completed - Gut Microbiome Clinical Trials

Effects of a Novel Food Product Containing Microbiota Accessible Carbohydrates on the Human Microbiome

Start date: January 16, 2017
Phase: N/A
Study type: Interventional

This is a randomized, 2-period crossover study aimed at assessing the effect of taking a food supplement containing a blend of microbial accessible carbohydrates on the diversity of the gut microbiome. Impacts to the skin, scalp and oral microbiomes; blood inflammatory biomarkers; quality and quantity of sleep; gastrointestinal quality of life; bowel habits, and facial skin features will also be evaluated.