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Dysbiosis clinical trials

View clinical trials related to Dysbiosis.

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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.

NCT ID: NCT06122636 Enrolling by invitation - Quality of Life Clinical Trials

Efficacy of a Probiotic and Microbiological Analysis on Oral Complications Induced by Antineoplastic Therapies in Patients With HNC

Start date: October 3, 2022
Phase: N/A
Study type: Interventional

The study is a Clinical Trial and the main objective is to Evaluate the effects of probiotics on oral complications induced by antineoplastic therapies in patients with head and neck cancer, attended at the radiotherapy service of the Catalan Institute of Oncology (ICO) Hospitalet and at the Dental Hospital of the University of Barcelona (HOUB), Faculty of Medicine and Health Sciences Bellvitge campus during the period 2022- 2024. Research question: Is the use of probiotics compared to placebo effective in reducing oral complications produced by antineoplastic therapies in patients with head and neck cancer attended in the radiotherapy service at the Catalan Institute of Oncology (ICO) Hospitalet and the Dental Hospital of the University of Barcelona, Faculty of Medicine and Health Sciences campus Bellvitge during the period 2022- 2024? Study population: Patients attended at the radiotherapy service of the Catalan Institute of Oncology (ICO) Hospitalet and at the Dental Hospital of the University of Barcelona (HOUB), (Master of Dentistry in Oncology and Immunocompromised Patients) diagnosed by histological confirmation of head and neck cancer and treated in the last year.Intervention: Patients who agree to participate in the study will be randomized to the intervention or control group. Two visits will be made, the first as a baseline measurement and the second after the end of the intervention. In the first visit they will be given the products either probiotic or placebo, with presentation of a box with 10 sachets. The probiotics contain: Lactobacillus Rhamnosus GG, Lactobacillus casei, Streptococcus thermophilus, Bifidobacterium breve, Lactobacillus acidophilus, Bifidobacterium infantis and Lactobacillus bulgaricus. 1 x 10e10 Colony Forming Units (CFU). And the placebo composed of excipients. They are gluten free. Each patient will be given 1 sachet dissolved in water, to take 2-3 minutes of mouthfuls then swallow, after brushing, once a day, for 30 days.

NCT ID: NCT06114303 Not yet recruiting - Dysbiosis Clinical Trials

Ex-vivo Evaluation of the Effect of 2 Probiotic Solutions (Lactibiane ATB and Lactibiane Enfant) and 5 Classes of Drugs on the Intestinal Microbiota

EPROMED
Start date: January 20, 2025
Phase:
Study type: Observational

The objective is to test ex-vivo the effects of two probiotic solutions (Lactibiane ATB and Lactibiane Enfant) and five classes of drugs (antibiotic, proton pump inhibitor, non-steroidal anti-inflammatory, anxiolytic and anti-depressant) on microbial microcosms derived from human stool samples (from adults and children) re-cultured under anaerobic conditions.

NCT ID: NCT06098404 Recruiting - Cancer Clinical Trials

Correlates of CRCI and Gut Microbiome Dysbiosis; a Pilot Study

Start date: March 4, 2024
Phase:
Study type: Observational

The aim of this study is to characterize the microbiome and assess fatigue and cognition of patients with cancer undergoing standard of care treatment.

NCT ID: NCT06095076 Recruiting - Dysbiosis Clinical Trials

Cutaneous Microbiota Evolution in ICU Patients With CVC (ICMc)

ICMc
Start date: June 2, 2023
Phase:
Study type: Observational

Intensive Care Unit (ICU) patients are exposed to catheter-related infections with an important morbidity. Catheter colonization is constant but infection is not. Cutaneous dysbiosis could be the missing link. Our study aims to evaluate the evolution of cutaneous microbiota in ICU patients with a central venous catheter in place, through metagenomics. Our main objective is to evaluate the evolution of alpha-diversity, quantified by intra-patient variation of Shannon diversity index (a diversity index used in bacterial metagenomics).