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Dysbiosis clinical trials

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NCT ID: NCT05834010 Recruiting - Anorexia Nervosa Clinical Trials

Feasibility Study of Using Fecal Microbiota Transplants in Anorexia Nervosa

ReBoot
Start date: March 18, 2023
Phase: Early Phase 1
Study type: Interventional

The investigators hypothesize that prolonged undernutrition in anorexia nervosa alters the microbiome to a different steady-state (dysbiotic) composition that sustains the disease, even after returning to normal diet. The investigators propose that transplanting a fully ecologically functioning GM from a healthy donor, through a FMT, can reboot the gut-brain-axis, ameliorate symptoms and improve clinical outcomes. To approach this, in the challenging AN patient group, the investigators want to conduct a FMT feasibility/pilot study.

NCT ID: NCT05824819 Recruiting - Endometriosis Clinical Trials

Endometriosis and Peritoneal Dysbiosis

Start date: May 1, 2023
Phase: N/A
Study type: Interventional

Endometriosis is a complex clinical syndrome that impairs many aspects of a woman's life, characterized by a chronic estrogen-dependent inflammatory process, mainly affecting the pelvic organs, with ectopic presence of tissue analogous to the uterine mucosa (endometrium). Despite intensive research in the field of etiopathogenesis, its cause has not yet been determined, and treatment remains symptomatic. Endometriosis causes two main complications, i.e. pelvic pain syndrome and infertility. In recent years, thanks to the analysis of the human microbiome, it has become possible to deepen the knowledge of the physiological and pathological interactions between microorganisms inhabiting various body areas and the host. Bacteria may enter the peritoneal cavity in the mechanism of retrograde menstruation and translocate from the intestines, and then promote the development of local and systemic inflammation, leading to the symptoms of endometriosis. The study is to determine whether the presence of a specific intestinal, peritoneal and uterine microbiome correlates with endometriosis stage and whether its presence predisposes to increased pain or infertility. Concordance or divergence of bacterial populations inhabiting the peritoneal and uterine cavities could have clinical implications, i.e. the possibility of empirical antibiotic therapy in patients undergoing only endometrial aspiration biopsy and not opting for surgical treatment.

NCT ID: NCT05812157 Recruiting - Clinical trials for Axial Spondyloarthritis

Optimizing Anti-IL17 Antibody Therapy by Associating Fiber Supplementation to Correct Treatment-aggravated Gut Dysbiosis in Axial Spondyloarthritis - RESPOND-IL17

RESPOND-IL17
Start date: October 2, 2023
Phase: N/A
Study type: Interventional

Fiber is the main source of energy for colonic bacteria and its consumption favorably modifies the composition of the microbiota in only a few days. Their fermentation in the colon releases short-chain fatty acids (SCFAs). Clostridiales contain many strains producing SCFAs. These SCFAs can restore the intestinal barrier and promote certain anti-inflammatory cells, including regulatory T cells (Tregs), which are essential to the mechanisms in tolerance of the self. Fibers could therefore correct the intestinal abnormalities present in patients with axial spondyloarthritis (AxSpA) and aggravated by anti-IL-17 drugs and thus improve the therapeutic response to these treatments. The hypothesis is that dietary fiber will correct the dysbiosis in AxSpA patients and increase the release of SCFAs, which favorably modulate the immune response and improve AxSpA.

NCT ID: NCT05790564 Recruiting - Metabolic Syndrome Clinical Trials

Almonds to Improve Gut Health and Decrease Inflammation

Start date: November 17, 2022
Phase: N/A
Study type: Interventional

Almonds are a good source of beneficial compounds. This study will investigate if eating almonds everyday for 12 weeks can affect gut health and inflammation in persons with metabolic syndrome. Investigators will measure changes in metabolism, heart health, and the levels of vitamins and other compounds from almonds.

NCT ID: NCT05779449 Recruiting - Clinical trials for Patient Participation

Targeting the Gut Dysbiosis to Treat Inflammation-driven Synaptopathy in MS

Pre-Pro-MS
Start date: July 26, 2023
Phase: N/A
Study type: Interventional

Inflammatory synaptopathy is a prominent pathogenic process in multiple sclerosis (MS) induced by imbalanced immune system homeostasis. Its persistence causes excitotoxic neuronal damage, leading to motor and cognitive deficits. Although many advances have been made in MS treatment, the development of effective strategies for managing disease progression driven by excitotoxic synaptic dysfunctions is of great significance. Gut dysbiosis is commonly associated with both MS and obesity and high-fat diet (HFD) can exacerbate disease by acting on gut microbiota. Since gut microbiota can shape the immune response and brain functions, we propose to target gut dysbiosis by dietary supplementation of prebiotics and probiotics (Pre-Pro) to treat synaptopathy in both human and experimental model of MS, even when exacerbated by HFD. Overall, this project aims at unveiling the anti-inflammatory and neuroprotective pathways activated by Pre-Pro supplementation to modulate the immune-synaptic axis.

NCT ID: NCT05775341 Recruiting - Clinical trials for Surgical Site Infection

INtestinal Dysbiosis and TRanslocation of Bacteria in Patients Undergoing Surgery

INTRA
Start date: February 27, 2023
Phase:
Study type: Observational [Patient Registry]

The goal of this observational study is to contribute to a better understanding of the perioperative kinetics of intestinal microbial composition and association with surgical site infections. The main question this study aims to determine if: - Patients undergoing surgery develop transient intestinal dysbiosis - Such transient dysbiosis is associated with translocation to the systemic circulation and surgical site infection Patients undergoing elective abdominal surgery will be included prospectively. Informed consent will be obtained. From patients the following information and samples will be collected: - Perioperative: Baseline health data, nutrition data, measurement body composition, glucose monitoring - Intraoperatively: - Mucosal swabs - Blood from central venous catheter and portal vein - Mesenteric lymph node - Intestinal specimen - Bile - Subcutaneous biopsy - Postoperatively: - If a surgical site infection occurs samples from infected site

NCT ID: NCT05658263 Recruiting - Sarcopenia Clinical Trials

Bacterial Intestinal Gut Modification Around Cancer Surgery (BIG MACS) Diet

Start date: January 3, 2023
Phase: Early Phase 1
Study type: Interventional

The long-term study objective is to develop optimized nutritional therapies for surgery and test them in clinical practice. This pilot study will test a microbiome-optimization diet in colorectal cancer surgery patients. The study hypothesizes that the Bacterial Intestinal Gut Modification Around Cancer Surgery (BIG MACS) Diet will provide participants with increased microbiota accessible carbohydrates (MACs) to support the microbiome and improve outcomes.

NCT ID: NCT05633706 Recruiting - Ulcerative Colitis Clinical Trials

Evaluation of the SIMBA Capsule for Small Intestinal Dysbiosis

Start date: January 9, 2023
Phase:
Study type: Observational

The SIMBA Capsule is a small, single-use, ingestible capsule that allows for the non-invasive sampling of small bowel contents using purely mechanical means. The study will compare the microbial and metabolomics analysis from the sample collected with the capsule series, to same-participant symptom questionnaires and stool microbial analysis.

NCT ID: NCT05622721 Recruiting - Clinical trials for Clostridium Difficile

REMBRANDT: REcovery of the MicroBiome fRom Antibiotics for Dental implanTs

Start date: May 30, 2022
Phase:
Study type: Observational

Antimicrobial therapy can lead to disruption of the gut microbiome and infection with Clostridioides difficile, a disease associated with high morbidity and mortality, particularly among the elderly. Drawing on observations that pet ownership and close contact with pets are protective against colonization with C. difficile and recurrence of C. difficile infection, the proposed study will test the hypothesis that microbiota that provide colonization resistance against C. difficile are shared between patients and their pets and that pet contact can mitigate antimicrobial-associated gut dysbiosis and the risk of C. difficile infection. This study will further define epidemiologic and pathophysiologic characteristics of C. difficile infection and gut microbiome dysbiosis that could enhance therapeutic options for these conditions, potentially through non-invasive interventions involving animal contact.

NCT ID: NCT05619055 Recruiting - Clinical trials for Necrotizing Enterocolitis of Newborn

The Intestinal Dysbacteriosis in the Pathogenesis of Necrotizing Enterocolitis

Start date: November 5, 2022
Phase:
Study type: Observational

Study Description The goal of this observational study is to detect intestinal flora and the metabolic products in premature infants diagnosed as necrotizing enterocolitis. The main questions it aims to answer are: - 1. Whether there is intestinal flora in the stool of premature infants. - 2. Are there dysregulated intestinal flora and their metabolic products in premature infants diagnosed as necrotizing enterocolitis. - 3. The detailed role and underlying mechanism of the intestinal dysbacteriosis and the metabolic products in premature infants diagnosed as necrotizing enterocolitis. Participants, premature infants diagnosed as necrotizing enterocolitis (NEC group), will be asked to collect stool (usually 2 times) for intestinal flora analysis. If there is a comparison group: Researchers will compare premature infants without necrotizing enterocolitis (control group) to see if their intestinal flora and the metabolic products also changed as their NEC counterparts.