Safety and Efficacy of Fecal Microbiota Transplantation

Launched by CHINESE UNIVERSITY OF HONG KONG · Jul 8, 2019

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of fecal microbiota transplantation (FMT) as a treatment for various digestive and related health issues, such as Crohn's disease, ulcerative colitis, and irritable bowel syndrome. FMT involves taking healthy stool from a donor and infusing it into a patient to help restore a balanced gut microbiota, which is essential for good health. While FMT has shown promise in treating conditions linked to imbalances in gut bacteria, like antibiotic-associated diarrhea and metabolic syndrome, the trial aims to gather more information about its safety and effectiveness in a typical clinical setting.

To participate in this trial, individuals must have a confirmed diagnosis of one of the specified conditions, such as Crohn's disease or obesity. However, those who are currently pregnant or have certain medical issues that could interfere with the procedure are excluded. Participants can expect to undergo FMT and will be monitored for any effects, both positive and negative, to help researchers better understand how well this treatment works. This trial is currently recruiting, and it represents an important step in exploring new treatment options for those with challenging health conditions.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Confirmed diagnosis of any of the following diseases:
• • Crohn's disease
• • Ulcerative colitis
• • Celiac disease
• • Irritable bowel syndrome
• • Functional dyspepsia
• • Constipation
• • Antibiotic-associated diarrhea or any antibiotic- associated complications/symptoms
• • Metabolic syndrome such as diabetes mellitus and obesity
• • Multidrug-resistant infection
• • Hepatic encephalopathy
• • Multiple sclerosis
• • Pseudo-obstruction
• • Carbapenem-resistant Enterobacteriaceae (CRE) or Vancomycin-resistant Enterococci (VRE) infection
• • Multiple organ dysfunction
• • Dysbiotic bowel syndrome
• • MRSA enteritis
• • Pseudomembranous enteritis
• • Alopecia, autism
• • Graft-versus-host disease
• • Idiopathic thrombocytopenic purpura (ITP)
• • Atopy or allergy
• • Liver disease such as Nonalcoholic fatty liver disease (NAFLD) and Nonalcoholic steatohepatitis (NASH)
• • Alcohol dependence
• • Psoriatic arthropathy that has suboptimal control of disease despite standard treatment.
• Exclusion Criteria:
• • Known contraindication to all FMT infusion method such as nasoduodenal tube insertion, oesophago-gastro-duodenoscopy (OGD), enteroscopy, colonoscopy and enema
• • Any conditions that may render the efficacy of FMT or at the discretion of the investigators
• • Current pregnancy