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Intestinal Microbiota clinical trials

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NCT ID: NCT06159244 Recruiting - Clinical trials for Intestinal Microbiota

Intestinal Microbiota Profiling in Severe Acute Alcoholic Hepatitis Patients

HepatAlc-IM
Start date: November 15, 2023
Phase: N/A
Study type: Interventional

In humans, alcohol-related dysbiosis exists with a decrease in bacteroides. This dysbiosis is responsible for the breakdown of the intestinal barrier by a decrease in the synthesis of protective mucus, and some proteins involved in tight junctions or a decrease in defensin (Reg3b, Reg3g) which promotes bacterial growth and ultimately bacterial translocation. The microbiota of a patient with alcoholic hepatitis is different from that of a patient without alcoholic hepatitis. Acute alcoholic hepatitis has a severe prognosis and corticosteroids are the only first line therapy option, with better survival at 28 days versus placebo. However, mortality remains high at 30% at 3 months, which highlights the importance of seeking intestinal microbiota profile on treatment response. The determination of one or more intestinal microbiota signatures associated with the treatment response Corticosteroids plus FMT or Corticosteroids plus placebo will allow the clinician to have a simple and rapid test obtained in 16S RNA analysis to predict the therapeutic response and potentially the best treatment to adopt and to address medical and medico-economic stakes. The investigators will first characterize the alcohol-induced dysbiosis by a whole microbiota sequencing in the different groups. Specific bacterial species identify by DNA sequencing should be confirmed by qPCR of 16S rDNA to determine a fingerprint of sAH microbiota. Metabolic properties of intestinal microbiota, such as production of short chain fatty acids, will be analyzed by using HPLC. In the sAH group, evolution of intestinal microbiota will be observed by shotgun DNA sequencing between the day 0 and the day 7 of corticosteroids treatment. The analysis of sAH patients' microbiota (day 0) will allow us to obtain a non-responder profile to corticosteroids that can be used as a prognostic marker to use in the clinic. The deliverable is the bacterial fingerprint of the treatment response and its valuation is its use as a predictive tool of the response.

NCT ID: NCT05776329 Completed - Obesity Clinical Trials

Dietary Intervention to Reduce Metabolic Endotoxemia

Start date: April 14, 2023
Phase: N/A
Study type: Interventional

The goal of this randomized clinical trial is to compare an antiinflammatory and environmentally friendly dietary strategy (AIA-D) designed based on the planetary health diet recommendations translated to the regional context and including nutrients related to antiinflammatory responses with an active control diet based on general healthy diet recommendations (CONV-D) in adults from 18 to 50 years of age with obesity (body mass index ≥30 kg/m2). The main questions it aims to answer are: - If the intervention with AIA-D will cause a significant decrease at the end of the intervention (six weeks) in lipopolysaccharide-binding protein (LBP) compared to CONV-D. - If intervention with AIA-D will cause a significant increase at the end of the intervention (six weeks) in the relative abundance of two specific bacteria genera (AM and FP) when compared to CONV-D. Participants will: - Sign the informed consent. - Provide two peripheral blood samples (taken by our trained professionals). - Provide two samples of feces. - Allow anthropometric (body weight, height, hip and waist circumferences) blood pressure measurements on two occasions. - Respond to 24 h dietary recall on two occasions. - Attend the 1-hour group sessions requested (three for AIA-D and one for CONV-D). - Follow the dietary recommendations provided. - Be willing to participate in social media groups to receive information and follow up during the six weeks of the intervention. Researchers will compare an antiinflammatory and environmentally friendly strategy (AIA-D) with an active control diet (CONV-D) based on general healthy diet recommendations to see if AIA-D decreases metabolic endotoxemia measured through LBP serum levels and increase the relative abundance of AM and FP, compared to CONV-D.

NCT ID: NCT05003505 Active, not recruiting - HPV Infection Clinical Trials

Characteristics of Vaginal and Intestinal Microbiota and Cervical HPV Infection

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

There are different microbial communities on the surface of human body (skin, hair, nails, etc.) and in the cavity connected with the outside world. The human microbiota is the general term of the genetic information of microorganisms that coexist with human beings and cause various diseases under certain conditions. The results of human microbial genome analysis show that the microbial communities in different parts of the human body and different individuals have amazing diversity, some of which play an important role in human health, and some are closely related to diseases. Female lower genital tract infection is often associated with human papillomavirus (HPV) infection and bacterial vaginosis (BV), such as cervical and vaginal precancerous lesions, cancer, condyloma acuminatum and other sexually transmitted diseases (STD). Persistent infection of high-risk human papillomavirus (HR-HPV) is closely related to the occurrence of invasive cervical cancer. New evidence suggests that vaginal microbiota composition is different in women with HR-HPV infection and high-grade cervical lesions. The increase of the severity of cervical intraepithelial neoplasia is related to the decrease of the relative abundance of vaginal Lactobacillus. In addition to vaginal microbes, the powerful intestinal flora is considered to be the "invisible organ" of the human body. There is a dynamic and balanced interaction network between intestinal microorganisms and human immune cells. Once the intestinal flora is out of balance, the changes in species, quantity, proportion, location and biological characteristics will cause a series of inflammatory reactions and immune system diseases, and even lead to cancer. Some studies have shown that there is a potential relationship between intestinal microorganisms and vaginal microorganisms. Recent research evidence suggests that the mutually beneficial relationship between oral bacteria and other vaginal bacteria supports the colonization of pathogens and may help maintain the characteristics of vaginal flora imbalance.

NCT ID: NCT04874883 Recruiting - Diarrhea Clinical Trials

Effect of the Use of Symbiotics in Patients With Colon Cancer

Start date: December 1, 2019
Phase: Phase 4
Study type: Interventional

Due to the high incidence, cancer and the concomitant presence of malnutrition are currently a worldwide public health problem. The loss of weight and body tissues is a common condition in cancer patients with lesions of the airways and digestive tract and is related to anorexia and the presence and duration of gastrointestinal symptoms, such as diarrhea. The latter directly interferes with the progression of enteral diets, which are administered in order to provide adequate nutritional support for the recovery of patients and nutritional status. In this sense, the importance of measures to help reduce diarrhea episodes is reinforced, aiming at the adequate infusion of enteral diets and, consequently, nutritional needs. It is known that the use of antimicrobials is closely related to the increased incidence of nasocomial diarrhea, as it facilitates colonization by pathogenic bacteria, such as Clostridium difficile. In addition, nosocomial diarrhea is a very relevant occurrence due to the financial burden it causes for the hospital institution, which can also worsen the patient's clinical condition, since he is weakened due to the underlying disease. Despite these important aspects, studies carried out with the aim of reducing diarrhea episodes in patients with airway and digestive lesions are still not described in the literature. In this context, the use of symbiotics presents itself as a possibly beneficial alternative, considering the role of probiotics and prebiotics in the modulation of intestinal function. In this sense, this work aims to evaluate the impact of perioperative supplementation with symbiotic on clinical outcomes and intestinal function of patients with colon cancer and digestive airways undergoing colorectal resection. It is assumed that the use of symbiotics could have better results than the use of probiotics and isolated prebiotics.

NCT ID: NCT04076592 Completed - Breastfeeding Clinical Trials

NUTRIPROTECT-Children Nutrition as a Protective or Health-risk Factor

My-Milk-2
Start date: February 1, 2018
Phase:
Study type: Observational

Despite the intensive worldwide research dedicated to the nutrition and faecal microbiota, the studies that follow the link between the early nutrition, initial intestinal microbiota, and development of children over a longer time period are limited. From 2010 to 2013, the investigators conducted a study "My-Milk" in Slovenia. From 185 participating pregnant women involved in the detailed part of the protocol (comprising of 4-days weighed dietary record, visits at clinic and biological sample collection), 152 participants completed the study at the child's first year of age. Five of the participants bore twins whose data was excluded from the research because infant's identity was not consistently followed throughout the research. In addition to studying the microbiota and fatty acid composition of breast milk and the initial development of intestinal microbiota of breastfed babies, the investigators also monitored the diet of expecting and nursing participants, concentration of vitamin D in serum and bone mineral density in participating mothers and children. The investigators performed anthropometric measurements of children during the first year of age. All singleton children who have completed My-Milk study (N= 147) will be invited in the follow-up study "My-Milk-2". The first step of the proposed study will be the evaluation of nutritional status of children aged 6 to 7 years in 2017/2018, including the assessment of the body composition (bone density, percentage of fat and muscle tissue), health indicators (blood pressure, blood cholesterol, frequency and severity of infections) and fecal microbiota. The obtained data of My-Milk and My-Milk-2 studies will enable the prospective cohort study to be carried out on the effects of early nutrition and various factors of mother and child during the first year of age on the health and developmental status of children aged 6- 7 years. The project results will significantly improve the progress in research areas of public health and nutrition. The interactions along the axis nutrition in early childhood, gut microbiota composition/ diversity and potential health problems in later life are still not fully explored. The investigators expect the results of the proposed study will contribute to the scientific development in this field in global prospective. The acquired information will also be an excellent basis for development of new dietary guidelines for children.

NCT ID: NCT03500601 Completed - Cognitive Function Clinical Trials

Effects of Consumption of Nut Components on Cognitive Function, Intestinal Microbial Communities and Markers of Health

Start date: November 22, 2017
Phase: N/A
Study type: Interventional

Tree nuts (for example brazil nuts, almonds, hazelnuts, walnuts, cashew nuts etc) contain a wide variety of nutrients including fatty acids, polyphenols and micronutrients. The beneficial health effects ascribed to the consumption of tree nuts include improvements to cardiovascular outcomes and regulation of glucose levels and inflammation. Emerging evidence suggests that specific components of nuts may also contribute to brain health and function. The aim of the present study is to assess the effects of four weeks' supplementation of nut components on cognition and subjective measures. Urinary metabolites and intestinal microbial communities will also be assessed allowing biomarkers of nut exposure to be highlighted.

NCT ID: NCT03487380 Terminated - Alzheimer Disease Clinical Trials

Taxonomic and Functional Composition of the Intestinal Microbiome: a Predictor of Rapid Cognitive Decline in Patients With Alzheimer's Disease

MiDCR
Start date: September 4, 2017
Phase: N/A
Study type: Interventional

The objective of the study is to highlight a modification of the composition of the intestinal microbiota associated with the diagnosis of Alzheimer's disease and its most unfavorable form, Rapid Cognitive Decline (DCR). This identification could lead to diagnostic strategies based on the analysis of the intestinal microbiome, and preventive and curative treatments, based on the modulation of intestinal microbiota

NCT ID: NCT03401736 Withdrawn - Clinical trials for Mechanical Ventilation

The Diversity of Intestinal Microbiota in Patients With Different Sedative-hypnotics Undergoing Mechanical Ventilation

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

Bidirectional communication between the CNS and the GI tract - the brain-gut axis - occurs both in health and disease.Patients with mechanical ventilation in ICU (ICU) often meet the necessary nutritional needs. These patients often appear varying degrees of intestinal flora imbalance, such as diarrhea, vomiting, abdominal distension and other complications, which exert negative effect on treatment and prolong hospitalization time.So far,whether the sedative drugs used for a long time in mechanically ventilated patients will affect the diversity of intestinal flora or not has not been reported.The effects of different sedative drugs on the intestinal flora diversity need further study.Therefore, this topic will used midazolam and dexmedetomidine to study the effect on the diversity of intestinal microbiota.Meanwhile,the research will provide a theoretical basis for rational use of mechanical ventilation and sedative drugs.

NCT ID: NCT02679183 Completed - Premature Infants Clinical Trials

Medically-Graded Honey Supplementation Formula To Preterm Infants

Honey
Start date: January 2011
Phase: Phase 0
Study type: Interventional

Honey is a natural product that contains multiple nutrients; it is composed of fructose, glucose and fructooligosaccharides that can potentially serve prebiotic functions. It also contains more than 180 substances including amino acids, vitamins, minerals and enzymes. Investigators hypothesized that supplementation of enteral feeds with honey would produce a bifidogenic effect and stimulate the immune response in preterm infants. Investigators randomly assigned subjects to 4 groups receiving 0, 5, 10 and 15 grams of honey daily for 2 weeks and measured their effect on stool colonization, systemic immune parameters and anthropometric measurements.

NCT ID: NCT02223468 Completed - Infection Clinical Trials

Human Microbiota and Liver Transplant

Start date: January 2016
Phase:
Study type: Observational

The microbiota represents the collections of microbial communities that colonize a host. In health, the microbiota protects against pathogens and maturation of the immune system. In return, the immune system determines the composition of the microbiota. Altered microbial composition (dysbiosis) has been correlated with a number of diseases in humans. The real role of the microbiota in transplant recipients is still unknown even though we suspect that it may be affected directly or indirectly by immunosuppressive drugs and antimicrobial prophylaxis taken by transplant patients, as well as by inflammatory process secondary to ischemia/reperfusion injury. A number of studies have investigated the impact of liver transplantation on the intestinal microbiota. In a recent analysis of stool flora (Microb Ecol 2013; 65: 781-791) in 12 liver transplant recipients, changes in the microbiota were correlated to post-transplant infections. The authors suggested that the shift to pathogenic strains of bacteria due to the use of prophylactic antibiotics may be contributing to post-transplant complications. In a larger study, Wu et al (Hepatobiliary Pancreat Dis Int 2012; 11: 40-50) demonstrated marked changes in the gut microbiota post-transplantation with an increase in Enterobacteriaceae and Enterococcus, and reduction in Eubacteria, Bifidobacterium and Lactobacillus species. These changes, however, resolved over time such that by 6 months, at times when bacterial prophylaxis ends and immunosuppression is reduced. A better characterization of the impact of post-transplant therapy on the human microbiota has the potential to improve our understanding of the infection process and translate into development of new therapeutic strategies. The main goal of this study is to characterize intestinal microbiota and confirm the same bacterial DNA in peripheral blood and portal lymph nodes in patients affected with end-stage chronic liver disease, and to analyze its evolution from the moment of inclusion in waiting list throughout the first year after liver transplantation. For each patient, a healthy CONTROL with a similar age (± 10 years) will be selected from the same family setting, in whom just one sample will be obtained during the enrollment phase. The second goal is to analyze the potential associations between microbiota flora and transplant outcomes during the same period.