Safety and Efficacy of Fecal Microbiota Transplantation

Not Applicable

Recruiting

• Conditions: Crohn Disease; Ulcerative Colitis; Celiac Disease; Irritable Bowel Syndrome; Functional Dysphonia; Constipation; Clostridium Difficile Infection; Diabetes Mellitus; Obesity; Multidrug -Resistant Infection

• Registration Number: NCT04014413
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-6-21
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The efficacy of FMT in treating dysbiosis-associated disorder will be assessed by number of patients who have improvement in clinical symptoms (depends on each disease as stated in outcome)

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0