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Gut Microbiota clinical trials

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NCT ID: NCT06396728 Not yet recruiting - Gut Microbiota Clinical Trials

Use of GI BIOTICS 100B UFC to Improve Intestinal Health in Older Adults

GIBIOTICS
Start date: June 1, 2024
Phase: N/A
Study type: Interventional

Type of study: Clinical Trial. Main objective: To study the effect of daily consumption of the probiotic (GI BIOTICS 100B UFC) on intestinal inflammatory markers, intestinal microbiota, intestinal health, body composition and sports performance in older adults for 8 weeks. Participant Population/Health Conditions: The study will involve 44 sedentary men with a body mass index > 25 kg/m2 and aged between 60 and 75 years. Participants Will: Be randomised into one of two groups: consumption of a placebo capsule (comparison group) and consumption of GI BIOTICS 100B UFC daily for a period of 8 weeks (experimental group). Provide feces and blood samples before and after the 8-week intervention. Undergo analysis of these samples using advanced techniques to understand the effect of the consumption of the probiotic. Undergo a submaximal stress test and muscle strength will be measured using a handgrip dynamometer.

NCT ID: NCT06288984 Not yet recruiting - Brain Injuries Clinical Trials

Effects of rTMS on Respiratory Function and Gut Microbiota in Patients With Brain Injury

Start date: March 1, 2024
Phase: N/A
Study type: Interventional

Impaired respiratory function may occur after brain injury, and will progress to restricted respiratory dysfunction without early intervention. At present, there is a lack of effective treatment options for respiratory dysfunction. Repetitive Transcranial Magnetic Stimulation(rTMS) is a non-invasive, painless and non-invasive neuroregulatory technique. In healthy people, rTMS applied to the respiratory motor cortex induces a contralateral respiratory muscle response. However, whether rTMS can improve respiratory function in patients with brain injury remains unclear. gut microbiota can affect muscle function and mass, and animal experiments have shown that probiotics can increase skeletal muscle mass and grip strength in mice. On the other hand, studies have found that rTMS can improve the nutritional status of patients with vegetative state by regulating the structure of gut microbiota. However, it remains unclear whether rTMS can improve respiratory muscle function in patients with brain injury by regulating gut microbiota. Therefore, the investigators intend to apply rTMS to the respiratory motor cortex to observe whether rTMS can improve respiratory function and reduce the incidence of pneumonia in patients with brain injury, and to observe the role of gut microbiota in this process.

NCT ID: NCT06136793 Not yet recruiting - Diabetes Mellitus Clinical Trials

HomeStyles-Adults of Chinese Heritage

Start date: June 2024
Phase: N/A
Study type: Interventional

Individuals of Chinese heritage are the largest and fastest growing segment of the US Asian population. US Chinese have sociodemographic characteristics and culture that differ substantially from other US Asians, and therefore, differ in social determinants of health, health status, and disease risk. US Chinese adults are at increased risk for cardiometabolic disease, related conditions (obesity, type 2 diabetes mellitus, hypertension), and systemic inflammation that promotes disease onset and progression. Immigration to a new country can substantially impact the gut microbiome which may promote systemic inflammation. Pilot interventions indicate a high-fiber diet rich in whole grains reduced inflammation and improved obesity. Additionally, the United States Department of Agriculture (USDA) supported, evidence-based HomeStyles intervention has demonstrated feasibility, acceptability, and efficacy in improving lifestyle behaviors and home environments associated with obesity risk in families. A lack of linguistically, culturally tailored interventions to their specific health needs makes it difficult for US Chinese to implement healthy lifestyle behaviors and reduce health risks. Interventions tailored for US Chinese that could attenuate modifiable cardiometabolic risk factors, understand physiological sequelae, and bridge health equity are not currently available. Thus, the overall goal of this project is to test the efficacy of HomeStyles in improving health outcomes in US Chinese. Project aims are to: A) Culturally adapt the HomeStyles intervention through community-engaged approaches. B) Conduct a 10-week, 2-armed Randomized Controlled Trial (RCT) to test HomeStyles intervention efficacy on health outcomes (dietary intake, physical activity, self-efficacy, HbA1C, waist circumference, and BMI), hypothesizing that participants randomized to the treatment condition will have greater improvements in health outcomes than control comparators. C) Examine associations between intervention participation and gut microbiota/systemic inflammation and test hypotheses that a whole-grain rich diet adopted by those in the intervention group will increase anti-inflammatory gut bacteria, reduce inflammatory gut bacteria, and lower systemic inflammation.

NCT ID: NCT05662514 Not yet recruiting - Clinical trials for Helicobacter Pylori Infection

Effect of Probiotics on Gut Microbiota During the Helicobacter Pylori Eradication

Start date: February 15, 2023
Phase: N/A
Study type: Interventional

Helicobacter pylori (H. pylori) is still infecting more than half of the population in many countries, although the prevalence is decreasing. As a main cause of chronic gastritis, peptic ulcer, and malignant gastric tumors, H. pylori places a heavy burden on developing countries and regions with high infection rate. In the last decade, the eradication rates of conventional regimens based on proton pump inhibitors (PPIs) plus antibiotics have been decreasing. Antibiotic resistance and decrease of drug compliance caused by adverse effects were the two main reasons for eradication failure. Moreover, H. pylori treatment causes dysbiosis of gut microbiota and increases the expression of antibiotic resistance gene. Therefore, eradication of H. pylori is facing a great challenge, and effective and safe methods are needed. To reduce adverse effects, improve drug compliance and increase eradication rates, certain probiotics were added to conventional regimens in several clinical studies. Probiotics were more or less shown to reduce adverse effects in the vast majority of clinical studies, but whether probiotics can improve the eradication rate of H. pylori remains controversial. Meanwhile, several studies focusing on the impact of probiotics on gut microbiota during H. pylori eradication have been published recently. Thus, we conducted a randomized, double-blind, placebo-controlled trial aiming to evaluate the effects of probiotics combining with 14-day bismuth quadruple therapy on H. pylori eradication.

NCT ID: NCT05481866 Not yet recruiting - Gut Microbiota Clinical Trials

Targeting Gut Microbiota and Metabolites for Very Preterm Infants Through Oropharyngeal Administration of Colostrum

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

Background: Oropharyngeal administration of colostrum (OAC) has an immune stimulating effect on oropharyngeal-associated lymphoid tissue, and can also promote the maturation of the gastrointestinal tract. However, how OAC promotes intestinal maturation in preterm infants by altering the gut microbiota remains unclear. We aim to assess the changes of gut microbiota and metabolites after OAC in very preterm infants. Methods: A multicenter, double-blind, randomized controlled trial will be conducted in 3 large NICUs in Shenzhen, China, for preterm infants with gestational age less than 32 weeks and birth weight less than 1500g. The intervention group will be given 0.2ml colostrum for oropharyngeal administration every 3 hours, which will start between the first 48 to 72 hours and continue for 5 consecutive days; The control group will be given sterile water for oropharyngeal administration, and the administration scheme will be the same as above. Stool samples will be collected at the first defecation and the 7th day after birth. It is estimated that 320 preterm infants will participate in the study within 1 year. 16sRNA gene sequencing and liquid chromatography-mass spectrometry will be used to analyze the effect of OAC on gut microbiota and metabolites. Discussion: The proposal advocates for the promotion of OAC as a safe and relatively beneficial initiative among neonatal intensive care units, and this initiative may contribute to the establishment of a dominant intestinal flora. Findings of this study may help to improve the health outcomes of preterm infants by constructing targeted gut microbiota in future studies.

NCT ID: NCT05123352 Not yet recruiting - Clinical trials for Acute Myeloid Leukemia

Investigation of the Gut Microbiota in Acute Myeloid Leukemia Receiving Two Different Induction Therapies

Start date: November 2021
Phase:
Study type: Observational

In this observational single-center cohort study, metagenomic Next-Generation Sequencing (mNGS) will be used to investigate the features and changes of gut microbiota in acute myeloid leukemia (AML) patients during the treatment of two different induction therapy regimens [standard intensive chemotherapy (7+3) or bcl-2 inhibitor-based targeted therapy].

NCT ID: NCT05039060 Not yet recruiting - Colorectal Cancer Clinical Trials

Modified MAC Diet and Gut Microbiota in CRC Patients

Start date: September 1, 2021
Phase: N/A
Study type: Interventional

To explore the changes in the composition and diversity of intestinal microbiota during 3-weeks of modified MAC diet and conventional diet in stage I or low-risk stage II colorectal cancer (CRC) patients after surgery. Additionally, the investigator analyze the association of gut microbiota and stool formation pattern or quality of life according to dietary pattern. Therefore, the investigator identify the beneficial or harmful microbiota composition and diversity adapting modified MAC diet that related to cancer recurrence, which provide supporting evidence for future prospective trial.

NCT ID: NCT04333004 Not yet recruiting - NSCLC Clinical Trials

Analysis of Gut Microbiota in Patients With Brain Metastasis of Non-small Cell Lung Cancer Treated by Pembrolizumab Combined With Chemotherapy

Start date: April 2020
Phase: Phase 1/Phase 2
Study type: Interventional

Analysis of Gut Microbiota in Patients With Brain Metastasis of Non-small Cell Lung Cancer Treated by Pembrolizumab Combined With Chemotherapy

NCT ID: NCT04316910 Not yet recruiting - Clinical trials for Postoperative Delirium

Characterisation of Gut Microbiota in Patients Undergoing Gastrointestinal Surgery With Postoperative Delirium (GIM-POD)

GIM-POD
Start date: July 19, 2023
Phase:
Study type: Observational

The study is a case-controlled observational trial. Sixty patients will be divided into 2 groups depending on whether postoperative delirium or not. This study aims to characterise the gut microbiota in patients undergoing gastrointestinal surgery with postoperative delirium. The CAM-ICU (Confusion Assessment Method for Intensive Care Unit) was used for delirium assessment.