NCT04706611 Efficacy and Safety of Fecal Microbiota Transplantation
| NCT ID | NCT04706611 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Guangzhou First People's Hospital |
| Condition | Fecal Microbiota Transplantation |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2021-01-15 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2021-01-15 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
In recent years, researches illustrate that multifactorial diseases such as functional gastrointestinal disorders, autoimmune diseases, metabolic, behavioral and neurological diseases are associated with an abnormal microbiome structure-dysbiosis, which means the imbalance of the microbiome community. Fecal microbiota transplantation (FMT), the infusion of faeces from a healthy donor to the gastrointestinal tract of a recipient patient aiming to alter the intestine microbiota, is recommended to be performed in Clostridium difficile infection(CDI) as the most effective therapy. It also being used experimentally in the treatment of the disease states linked to dysbiosis of the intestinal microbiota. However, the efficacy and safety of FMT to treat the dysbiosis-associated diseases is still in its infancy. To further verify the indications above, more data is required to be collected through studies.
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.
Contact & Investigator
Hongli Huang, MM
PRINCIPAL INVESTIGATOR
Guangzhou First People's Hospital
Frequently Asked Questions
Who can join the NCT04706611 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Fecal Microbiota Transplantation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04706611 currently recruiting?
Yes, NCT04706611 is actively recruiting participants. Contact the research team at eyzhouyongjian@scut.edu.cn for enrollment information.
Where is the NCT04706611 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT04706611 clinical trial?
NCT04706611 is sponsored by Guangzhou First People's Hospital. The principal investigator is Hongli Huang, MM at Guangzhou First People's Hospital. The trial plans to enroll 300 participants.