Efficacy and Safety of Fecal Microbiota Transplantation

Launched by GUANGZHOU FIRST PEOPLE'S HOSPITAL · Jan 10, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of a treatment called fecal microbiota transplantation (FMT). FMT involves taking stool from a healthy donor and transferring it to a patient’s intestines. The goal is to restore a healthy balance of bacteria in the gut, which can be disrupted in various conditions like irritable bowel syndrome, Crohn's disease, and even some neurological disorders. While FMT is already known to help with Clostridium difficile infections, researchers want to explore its potential benefits for other diseases linked to an unhealthy gut microbiome.

To participate in the trial, you must be diagnosed with one of several specific conditions, such as ulcerative colitis, obesity, or diabetes, and be able to tolerate the method of FMT, which might involve procedures like colonoscopy. The study is open to adults aged 18 and older, and it’s currently recruiting participants. If you join, you can expect close monitoring and care throughout the process as researchers gather valuable data to better understand how FMT might help in treating various health issues associated with gut microbiome imbalances.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Confirmed diagnosis of any of following diseases:
• • Irritable Bowel Syndrome
• • Ulcerative colitis
• • Crohn's disease
• • Constipation
• • Clostridium Difficile Infection
• • Functional Dyspepsia
• • Parkinson's Disease
• • Metabolic Syndrome
• • Non-Alcoholic Fatty Liver Disease
• • Autism Spectrum Disorder
• • Radiation Enteritis
• • Atopic Dermatitis
• • Food Allergic
• • Graft-versus-Host Disease
• • Obesity
• • Diabetes mellitus
• • Multi-Drug Resistant Infection
• • Hepatic Encephalopathy
• • Enteric Dysbacteriosis
• • Multiple Sclerosis
• • Pseudomembranous Enteritis
• • Acute Pancreatitis
• • Chronic Fatigue Syndrome
• • Acute-on-chronic Liver Failure with HBV Infection
• • Alcoholic Liver Disease
• • Anorexia
• • Decompensated Cirrhosis
• • Henoch-Schonlein Purpura
• • Autoimmune Liver Disease
• • Systemic Lupus Erythematosus
• • Rheumatoid arthritis
• • IgG4-Related Disease
• • Celiac Disease
• • Protein-losing Enteropathy
• • Asperger Syndrome
• • Rheumatoid arthritis
• • Psoriasis
• • Ankylosing spondylitis
• • Immune checkpoint inhibition-related colitis
• • Autoimmune enteropathy
• • Drug-induced diarrhea
• • Suffering from gastrointestinal symptoms such as constipation, diarrheas, abdominal pain, flatulence, etc.
• • The participants must be able to tolerate the FMT infusion method such as endoscopy, colonoscopy, capsule, nasoduodenal tube insertion, etc.
• Exclusion Criteria:
• • Current pregnancy or breast-feeding;
• • Suffering from other severe diseases, including liver or kidney failure, heart failure, MODS, coma, cerebrovascular accident;
• • Known contraindication to all FMT infusion method such as nasoduodenal tube insertion, endoscopy, colonoscopy and enema;
• • Any conditions that may render the efficacy of FMT or at the discretion of the investigators.