Dysbiosis and the immune system.
Maayan Levy, Aleksandra A Kolodziejczyk, Christoph A Thaiss...
https://pubmed.ncbi.nlm.nih.gov/28260787Actively Recruiting
Phase Not Applicable
Age: 18Years - 70Years
All Genders
ID04706611
Efficacy and Safety of Fecal Microbiota Transplantation in Patients With Intestinal Dysbiosis - A Pilot Study
Led by Guangzhou First People's Hospital · Updated on 2021-04-08
300
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the use of fecal microbiota transplantation (FMT) to treat a variety of diseases linked to imbalances in the gut microbiome, known as dysbiosis. These diseases include functional gastrointestinal disorders, autoimmune diseases, metabolic, behavioral, and neurological conditions. While FMT is already recommended for Clostridium difficile infection, its safety and effectiveness for other dysbiosis-related diseases are still being explored through this pilot study. Participants will receive FMT, which involves transferring feces from a healthy donor into the patient's gastrointestinal tract to alter their intestinal microbiota. The study includes various disease groups such as irritable bowel syndrome, ulcerative colitis, Crohn's disease, Parkinson's disease, metabolic syndrome, and many others. The treatment is delivered using methods like endoscopy, colonoscopy, capsules, or nasoduodenal tube insertion. During the study, participants' gastrointestinal symptoms will be monitored using the Gastrointestinal Symptom Rating Scale over one year to assess FMT's effectiveness. Researchers will also track any treatment-related adverse events using standard criteria. Participants must tolerate the infusion methods, and the study runs until the end of 2026, involving regular assessments and safety monitoring throughout.
CONDITIONS
Brief Title
Efficacy and Safety of Fecal Microbiota Transplantation
Who Can Participate
Age: 18Years - 70Years
All Genders
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 70 years
- Confirmed diagnosis of at least one listed disease such as irritable bowel syndrome, ulcerative colitis, Crohn's disease, constipation, Clostridium difficile infection, Parkinson's disease, metabolic syndrome, or others specified
- Experiencing gastrointestinal symptoms like constipation, diarrhea, abdominal pain, or flatulence
- Ability to tolerate FMT infusion methods such as endoscopy, colonoscopy, capsule, or nasoduodenal tube insertion
You will not qualify if you...
- Current pregnancy or breastfeeding
- Suffering from severe diseases including liver or kidney failure, heart failure, multiple organ dysfunction syndrome, coma, or cerebrovascular accident
- Known contraindications to all FMT infusion methods such as nasoduodenal tube insertion, endoscopy, colonoscopy, and enema
- Any condition that may affect the efficacy of FMT or as determined by the investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 1 year
Participants receive fecal microbiota transplantation through methods such as endoscopy, colonoscopy, capsule, or nasoduodenal tube insertion.
1 treatment visit plus follow-up visits as needed during the year
Trial Site Locations
Total: 1 location
1
Guangzhou First People's Hospital
Guangzhou, Guangdong, China, 510180
Actively Recruiting
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Research Team
Y
Yongjian Zhou, MM
H
Hongli Huang, MM
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
40
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Published Research Related To This Trial
American Journal of Gastroenterology Lecture: Intestinal microbiota and the role of fecal microbiota transplant (FMT) in treatment of C. difficile infection.
Lawrence J Brandt
https://pubmed.ncbi.nlm.nih.gov/23318479Multidonor intensive faecal microbiota transplantation for active ulcerative colitis: a randomised placebo-controlled trial.
Sudarshan Paramsothy, Michael A Kamm, Nadeem O Kaakoush...
https://pubmed.ncbi.nlm.nih.gov/28214091Clinical Application and Potential of Fecal Microbiota Transplantation.
R E Ooijevaar, E M Terveer, H W Verspaget...
https://pubmed.ncbi.nlm.nih.gov/30403550Gut microbiota and obesity: An opportunity to alter obesity through faecal microbiota transplant (FMT).
Patrick Lee, Bruce R Yacyshyn, Mary B Yacyshyn
https://pubmed.ncbi.nlm.nih.gov/30328245Fecal microbiota transplant from a rational stool donor improves hepatic encephalopathy: A randomized clinical trial.
Jasmohan S Bajaj, Zain Kassam, Andrew Fagan...
https://pubmed.ncbi.nlm.nih.gov/28586116Neuroprotective effects of fecal microbiota transplantation on MPTP-induced Parkinson's disease mice: Gut microbiota, glial reaction and TLR4/TNF-α signaling pathway.
Meng-Fei Sun, Ying-Li Zhu, Zhi-Lan Zhou...
https://pubmed.ncbi.nlm.nih.gov/29471030Faecal microbiota transplantation versus placebo for moderate-to-severe irritable bowel syndrome: a double-blind, randomised, placebo-controlled, parallel-group, single-centre trial.
Peter Holger Johnsen, Frank Hilpüsch, Jorunn Pauline Cavanagh...
https://pubmed.ncbi.nlm.nih.gov/29100842Efficacy of faecal microbiota transplantation for patients with irritable bowel syndrome in a randomised, double-blind, placebo-controlled study.
Magdy El-Salhy, Jan Gunnar Hatlebakk, Odd Helge Gilja...
https://pubmed.ncbi.nlm.nih.gov/31852769Fecal Microbial Transplantation and Its Potential Application in Cardiometabolic Syndrome.
Avner Leshem, Nir Horesh, Eran Elinav
https://pubmed.ncbi.nlm.nih.gov/31258528