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Dysbiosis clinical trials

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NCT ID: NCT06368895 Recruiting - Clinical trials for Hepatic Encephalopathy

Fecal Microbiota Transplantation by Oral Capsules for Hepatic Encephalopathy Treatment

Start date: April 7, 2021
Phase: Phase 1
Study type: Interventional

This interventional study aims to evaluate the safety and efficacy of oral capsule fecal microbiota transplantation (FMT) for treating hepatic encephalopathy refractory to conventional rifaximin and lactulose therapy in patients with liver cirrhosis. Patients diagnosed with hepatic encephalopathy refractory to rifaximin and lactulose therapy will be randomized into three groups. While continuing conventional therapy, the first group receives FMT via colonoscopy and oral capsule administration, the second group receives only oral capsule administration, and the third group serves as a control, receiving only conventional therapy. The aims of the study are: To evaluate the efficacy and safety of FMT by oral capsules in cirrhotic patients with hepatic encephalopathy refractory to standard therapy. To evaluate changes in the gut microbiota composition and in the intestinal and systemic inflammatory condition occurring after FMT and if they can be associated with clinical improvement. To evaluate metabolic modifications occurring after FMT and if they can be associated with clinical improvement.

NCT ID: NCT06349122 Not yet recruiting - Bacterial Vaginosis Clinical Trials

Screen-and-treat Strategy for Vaginal Flora Abnormalities in Pregnant Women at High Risk of Preterm Birth

AUTOP2
Start date: August 2024
Phase: Phase 4
Study type: Interventional

Preterm birth is an important cause of death and disabilities. Bacterial vaginosis (BV) is a common vaginal dysbiosis or abnormal microbiota, with a predominance of anaerobic bacteria with a lack of Lactobacillus, with various diagnosis methods. Often asymptomatic, BV increases the risk of preterm birth according to the gestational age at diagnosis. BV is usually diagnosed by conventional diagnosis such as Nugent score. Molecular diagnosis of BV has been demonstrated to be more reproducible, more accurate and to better define dysbiosis. The main objective of the study is to evaluate the effectiveness of an innovative screen-and-treat strategy for vaginal flora abnormalities by molecular biology using a Point of Care multiplex technology before 18 weeks' gestation to reduce the rate of preterm birth in a population of pregnant women at high risk of preterm birth. The hypothesis is that a strategy for screening and treating vaginal flora abnormalities and their recurrences using molecular biology in women with a history of prematurity or late-term abortion could be effective in reducing premature births by 40%.

NCT ID: NCT06329596 Not yet recruiting - Dysbiosis Clinical Trials

Microbiome Alterations With Xylitol (MAX) in Pregnancy

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

The purpose of this study is to understand if chewing xylitol-gum initiated before 20 weeks of pregnancy and continued until delivery affects the bacteria that are found in the oral and vaginal cavities, signs of inflammation within the gingiva of the oral cavity, the health of the tissues in the mouth (clinical parameters of periodontal disease), and the bacteria in the mouth and gut of newborns among pregnant individuals in Malawi.

NCT ID: NCT06295575 Completed - Clinical trials for Congenital Heart Disease

Effect of Probiotics on Patients With Congenital Heart Disease Following Cardiopulmonary Bypass

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

A randomized, controlled study including infants with non-cyanosis congenital heart disease (CHD) in need of surgical correction involving cardiopulmonary bypass (CPB) was established. Infants aged 1 month to 1 years were enrolled between June 2021 and July 2022. The patients in treatment group were supplied with probiotics consisting of Bifidobacterium infantis and Lactobacillus perioperatively and patients in control group were provided with placebo. Data concerning patients' clinical outcome such as diarrhea were collected. Blood samples were collected for measurement of fatty acid binding protein 2 (FABP2), diamine oxidase (DAO), d-lactic acid (D-LA) and C-reactive protein (CRP). Stool samples were collected to investigate the changes of intestinal flora.

NCT ID: NCT06252831 Completed - Dysbacteriosis Clinical Trials

Study of the Safety and Tolerability of the Broad-spectrum Probiotic Medicine "AS-Probionorm"

Start date: September 2, 2023
Phase: Phase 1
Study type: Interventional

The subject of this clinical trial is the medicine "AS-Probionorm". Pharmacological group - Antidiarrheal drugs. Antidiarrheal microorganisms. Microorganisms that produce lactic acid. The investigational probiotic medicine "AS-Probionorm" was created on the basis of an association of lactic acid bacteria with targeted action for oral use for the treatment of inflammatory and infectious diseases of the human gastrointestinal tract. The first phase of a clinical trial is the first test of a medicine conducted on healthy volunteers to establish tolerability and safety. According to the goal and objectives of the phase I clinical trial, the main parameter is to study the safety and tolerability of the medicine throughout the entire study period. Phase I of the clinical trial of the medicine included 20 healthy subjects of both sexes aged 18-50 years. Clinical and laboratory parameters to characterize the safety of the medicine: medical history, physical examination, ECG, general and biochemical blood tests, urine and stool tests. Selection and Exclusion of Subjects: Prior to inclusion in a clinical trial, each trial subject must first sign an Informed Consent Form for Participation in the Study, followed by a screening examination of each subject, including a variety of procedures, medical history, and physical examination. Each subject participating in the survey will be assigned an identification number. Study design: open-label, single-center, phase I of clinical trial. Dosage regimen - 1 sachet (1 g) 2 times a day with an interval of 12 hours. The total duration of study subjects' participation in the study is 21 days. Tolerability of the study drug: Tolerability of the drug will be assessed based on subjective symptoms and sensations reported by patients and objective data obtained by the investigator during the study. The frequency of occurrence and nature of adverse reactions are also taken into account. The degree of tolerability of the study drug will be determined in three gradations: intolerance, absence of undesirable drug reactions (side reactions), undesirable drug reactions (side effects) not classified as serious. Ethical and Legal Issues in Clinical Research: This clinical trial will be conducted in accordance with the principles set forth by the 18th World Medical Assembly (Helsinki, 1964) and the ICH guidelines for good clinical practice (GCP), and in accordance with all international and national laws and regulations.

NCT ID: NCT06231849 Not yet recruiting - Opioid Use Clinical Trials

Gut Microbiota Dysbiosis in Opioid Use Disorders: Implications for Clinical Symptoms and Relapse Rate.

Start date: February 2024
Phase:
Study type: Observational

This study will aim to investigate the gut microbiota in Egyptian patients with opioid use disorders and correlate microbiota bacterial abundance with clinical data.

NCT ID: NCT06231303 Not yet recruiting - Clinical trials for Gut Microbiota Dysbiosis in Lupus Nepheritis

Gut Microbiota Dysbiosis in Lupus Nephritis

Start date: January 2025
Phase:
Study type: Observational

Evaluate dysbiosis of some intestinal microbiota in adult patients with lupus nephritis compared to healthy controls.

NCT ID: NCT06196450 Recruiting - Clinical trials for Environmental Enteric Dysfunction

Maternal Probiotic Intervention to Improve Gut Health

MPIGH
Start date: June 22, 2023
Phase: Phase 2
Study type: Interventional

This trial will determine if a well-established probiotic, Vivomixx, can modulate maternal microbiota and ameliorate maternal environmental enteropathy which compromises growth in the first 1000 days. The probiotic Vivomixx has been used in many thousands of people including pregnant women, both within and outside a research context. This trial is the first in a proposed series of proof-of-concept intervention studies which are intended to provide data to enable a rational selection of interventions to be evaluated at scale in future large scale trials in which birth outcomes and postnatal growth will be key endpoints.

NCT ID: NCT06175260 Completed - Healthy Clinical Trials

Investigation on the Efficacy of Oral Carnitine Challenge Test Based on a Gut Microbiota Functional Test

Start date: June 5, 2019
Phase:
Study type: Observational

This study seeks to enlist healthy volunteers to form a validation cohort. The purpose is to confirm the observed correlations between the gut microbiome and the capacity to produce trimethylamine N-oxide (TMAO), which will be assessed using the oral carnitine challenge test (OCCT).

NCT ID: NCT06161285 Not yet recruiting - Bronchiolitis Clinical Trials

Association of Dysbiosis and Immune Response in Bronchiolitis in Under 12 Months -Old Infants

BRONCHOBIOTE
Start date: April 2024
Phase: N/A
Study type: Interventional

Acute bronchiolitis is a common disease in children under the age of two, caused mainly by the respiratory syncytial virus (RSV). Furthermore, given the same medical history, it is still very difficult to predict the course and severity of the infection at the onset of symptoms, Some studies have highlighted the importance of the microbiota (intestinal, oral or nasopharyngeal) and of the immune response to RSV in children, We will include 80 children under 2 years old with hospitalized bronchiolitis and non-hospitalized bronchiolitis. Oral, nasal and stool samples will be taken to study the various microbiota in search of dysbiosis. A capillary blood sample will be taken for immune studies.