Home
Clinical Trials
Safety and Efficacy of Fecal ...

Safety and Efficacy of Fecal Microbiota Transplantation

Last Updated: 2024-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-15

Study Completion Date

2030-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Standardized Fecal Microbiota Transplantation for Ulcerative Colitis

NCT01790061

Bacteria Microbiota Fecal Microbiota Transplantation +2 more

RECRUITING PHASE2/PHASE3

Fecal Microbiota Transplantation in the Treatment of Inflammatory Bowel Disease

NCT04436874

Fecal Microbiota Transplantation

UNKNOWN NA

Standardized Fecal Microbiota Transplantation for Crohn's Diseases

NCT01793831

Inflammatory Bowel Disease Crohn's Disease (CD)

RECRUITING NA

The Study of Efficacy and Mechanism in Fecal Microbiota Transplantation in the Treatment of Ulcerative Colitis

NCT02435160

Ulcerative Colitis Fecal Microbiota Transplantation

UNKNOWN PHASE2/PHASE3

Fecal Microbiota Transplantation for Ulcerative Colitis

NCT03804931

Ulcerative Colitis Fecal Microbiota Transplantation

RECRUITING PHASE2/PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Crohn Disease Ulcerative Colitis Celiac Disease Irritable Bowel Syndrome Functional Dysphonia Constipation Clostridium Difficile Infection Diabetes Mellitus Obesity Multidrug -Resistant Infection Hepatic Encephalopathy Multiple Sclerosis Pseudo-Obstruction Carbapenem-Resistant Enterobacteriaceae Infection Vancomycin Resistant Enterococci Infection Multiple Organ Dysfunction Syndrome Dysbiotic Bowel Syndrome MRSA Enteritis Pseudomembranous Enterocolitis Alopecia Autism Graft-versus-host Disease Idiopathic Thrombocytopenic Purpura Atopy or Allergy Liver Disease Alcohol Dependence Psoriatic Arthropathy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Crohn's disease

Fecal Microbiota Transplant will be performed.

Group Type EXPERIMENTAL