Using fecal microbiota transplantation to treat various diseases
Efficacy and Safety of Fecal Microbiota Transplantation in Patients With Intestinal Dysbiosis -A Pilot Study
NA · Guangzhou First People's Hospital · NCT04706611
This study is testing whether fecal microbiota transplantation can help people with various health issues related to gut imbalances, like digestive problems and autoimmune diseases.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Guangzhou First People's Hospital (other) |
| Drugs / interventions | Radiation |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT04706611 on ClinicalTrials.gov |
What this trial studies
This study investigates the efficacy and safety of fecal microbiota transplantation (FMT) as a treatment for a range of diseases associated with dysbiosis, including gastrointestinal disorders, autoimmune diseases, and metabolic conditions. FMT involves infusing feces from a healthy donor into the gastrointestinal tract of a patient to restore a balanced microbiome. The study aims to gather more data on the effectiveness of FMT for these conditions, which is still in the early stages of research. Participants will be monitored for safety and treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with conditions such as irritable bowel syndrome, ulcerative colitis, Crohn's disease, and other specified diseases linked to microbiome imbalance.
Not a fit: Patients with conditions not related to dysbiosis or those who do not meet the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel treatment option for patients suffering from a variety of dysbiosis-related diseases.
How similar studies have performed: Other studies have shown promising results with fecal microbiota transplantation for Clostridium difficile infection, but the application for other diseases is still being explored.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Guangzhou, Guangdong
- Guangzhou First People's Hospital — Guangzhou, Guangdong, China (RECRUITING)
Study contacts
- Principal investigator: Hongli Huang, MM — Guangzhou First People's Hospital
- Study coordinator: Yongjian Zhou, MM
- Email: eyzhouyongjian@scut.edu.cn
- Phone: 86-13503060150
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Fecal Microbiota Transplantation