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NCT Number: NCT04014413

Safety and Efficacy of Fecal Microbiota Transplantation

The gut microbiota is critical to health and functions with a level of complexity comparable to that of an organ system. Dysbiosis, or alterations of this gut microbiota ecology, have been implicated in a number of disease states. Fecal microbiota transplantation (FMT), defined as infusion of feces from healthy donors to affected subjects, is a method to restore a balanced gut microbiota and has attracted great interest in recent years due to its efficacy and ease of use. FMT is now recommended as the most effective therapy for CDI not responding to standard therapies.

Recent studies have suggested that dysbiosis is associated with a variety of disorders, and that FMT could be a useful treatment. Randomized controlled trial has been conducted in a number of disorders and shown positive results, including alcoholic hepatitis, Crohn's disease (CD), ulcerative colitis (UC), pouchitis, irritable bowel syndrome (IBS), hepatic encephalopathy and metabolic syndrome. Case series/reports and pilot studies has shown positive results in other disorders including Celiac disease, functional dyspepsia, constipation, metabolic syndrome such as diabetes mellitus, multidrug-resistant, hepatic encephalopathy, multiple sclerosis, pseudo-obstruction, carbapenem-resistant Enterobacteriaceae (CRE) or Vancomycin-resistant Enterococci (VRE) infection, radiation-induced toxicity, multiple organ dysfunction, dysbiotic bowel syndrome, MRSA enteritis, Pseudomembranous enteritis, idiopathic thrombocytopenic purpura (ITP), and atopy.

Despite FMT appears to be relatively safe and efficacious in treating a wide range of disease, its safety and efficacy in a usual clinical setting is unknown. More data is required to confirm safety and efficacy of FMT. Therefore, the investigators aim to conduct a pilot study to investigate the efficacy and safety of FMT in a variety of dysbiosis-associated disorder.

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Key information

Conditions

Crohn Disease Alcohol Dependence Alcohol-Related Disorders Alcoholism Alopecia Arthritis Arthritis, Psoriatic Atopy or Allergy Autism Autism Spectrum Disorder Autistic Disorder Autoimmune Diseases Autoimmune Diseases of the Nervous System Bacterial Infections Bacterial Infections and Mycoses Blood Coagulation Disorders Blood Platelet Disorders Body Weight Bone Diseases Brain Diseases Brain Diseases, Metabolic Carbapenem-Resistant Enterobacteriaceae Infection Celiac Disease Central Nervous System Diseases Chemically-Induced Disorders Child Development Disorders, Pervasive Clostridium Difficile Infection Clostridium Infections Colitis Colitis, Ulcerative Colonic Diseases Colonic Diseases, Functional Constipation Cytopenia Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Diabetes Mellitus Digestive System Diseases Dysbiotic Bowel Syndrome Endocrine System Diseases Enterocolitis Enterocolitis, Pseudomembranous Functional Dysphonia Gastroenteritis Gastrointestinal Diseases Glucose Metabolism Disorders Graft vs Host Disease Graft-Versus-Host Disease Gram-Positive Bacterial Infections Hair Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders Hepatic Encephalopathy Hepatic Insufficiency Hypersensitivity Hypotrichosis Idiopathic Thrombocytopenic Purpura Immune System Diseases Infections Inflammatory Bowel Diseases Intestinal Diseases Irritable Bowel Syndrome Joint Diseases Liver Disease Liver Diseases Liver Failure MRSA Enteritis Malabsorption Syndromes Mental Disorders Metabolic Diseases Multidrug -Resistant Infection Multiple Organ Dysfunction Syndrome Multiple Organ Failure Multiple Sclerosis Musculoskeletal Diseases Nervous System Diseases Neurodevelopmental Disorders Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pseudo-Obstruction Pseudomembranous Enterocolitis Psoriasis Psoriatic Arthropathy Purpura Purpura, Thrombocytopenic Purpura, Thrombocytopenic, Idiopathic Shock Signs and Symptoms Signs and Symptoms, Digestive Skin Diseases Skin Diseases, Papulosquamous Skin Manifestations Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Substance-Related Disorders Thrombocytopenia Thrombotic Microangiopathies Ulcerative Colitis Vancomycin Resistant Enterococci Infection

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Chinese University of Hong Kong

Hong Kong, Shatin, 000000

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fecal Microbiota Transplantation

Procedure

Fecal microbiota transplantation

Primary outcomes

  1. 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)

    Time frame: 1 year

Secondary outcomes

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

    Time frame: 1 year

Other outcomes

  1. Any improvement or deterioration or recurrence of the underlying condition by clinical judgement of doctors

    Time frame: 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Matthew Fung

CONTACT

[email protected]

+852 35053855

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

Safety and Efficacy of Fecal Microbiota Transplantation: A Pilot Study

Important dates

Study start
2019
Primary completion
2030
Study completion
2030
First posted
Jul 10, 2019
Registry last updated
Aug 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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