ClinicalTrials.Veeva
Menu

Efficacy and Safety of Fecal Microbiota Transplantation (FMT)

G

Guangzhou First People's Hospital

Status

Enrolling

Conditions

Fecal Microbiota Transplantation

Treatments

Procedure: Fecal Microbiota Transplantation

Study type

Interventional

Funder types

Other

Identifiers

NCT04706611
B-2019-041-01

Details and patient eligibility

About

In recent years, researches illustrate that multifactorial diseases such as functional gastrointestinal disorders, autoimmune diseases, metabolic, behavioral and neurological diseases are associated with an abnormal microbiome structure-dysbiosis, which means the imbalance of the microbiome community. Fecal microbiota transplantation (FMT), the infusion of faeces from a healthy donor to the gastrointestinal tract of a recipient patient aiming to alter the intestine microbiota, is recommended to be performed in Clostridium difficile infection(CDI) as the most effective therapy. It also being used experimentally in the treatment of the disease states linked to dysbiosis of the intestinal microbiota. However, the efficacy and safety of FMT to treat the dysbiosis-associated diseases is still in its infancy. To further verify the indications above, more data is required to be collected through studies.

Read more

Enrollment

300 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Confirmed diagnosis of any of following diseases:

  • Irritable Bowel Syndrome
  • Ulcerative colitis
  • Crohn's disease
  • Constipation
  • Clostridium Difficile Infection
  • Functional Dyspepsia
  • Parkinson's Disease
  • Metabolic Syndrome
  • Non-Alcoholic Fatty Liver Disease
  • Autism Spectrum Disorder
  • Radiation Enteritis
  • Atopic Dermatitis
  • Food Allergic
  • Graft-versus-Host Disease
  • Obesity
  • Diabetes mellitus
  • Multi-Drug Resistant Infection
  • Hepatic Encephalopathy
  • Enteric Dysbacteriosis
  • Multiple Sclerosis
  • Pseudomembranous Enteritis
  • Acute Pancreatitis
  • Chronic Fatigue Syndrome
  • Acute-on-chronic Liver Failure with HBV Infection
  • Alcoholic Liver Disease
  • Anorexia
  • Decompensated Cirrhosis
  • Henoch-Schonlein Purpura
  • Autoimmune Liver Disease
  • Systemic Lupus Erythematosus
  • Rheumatoid arthritis
  • IgG4-Related Disease
  • Celiac Disease
  • Protein-losing Enteropathy
  • Asperger Syndrome
  • Rheumatoid arthritis
  • Psoriasis
  • Ankylosing spondylitis
  • Immune checkpoint inhibition-related colitis
  • Autoimmune enteropathy
  • Drug-induced diarrhea
  • Suffering from gastrointestinal symptoms such as constipation, diarrheas, abdominal pain, flatulence, etc.
  • The participants must be able to tolerate the FMT infusion method such as endoscopy, colonoscopy, capsule, nasoduodenal tube insertion, etc.

Exclusion criteria

  • Current pregnancy or breast-feeding;
  • Suffering from other severe diseases, including liver or kidney failure, heart failure, MODS, coma, cerebrovascular accident;
  • Known contraindication to all FMT infusion method such as nasoduodenal tube insertion, endoscopy, colonoscopy and enema;
  • Any conditions that may render the efficacy of FMT or at the discretion of the investigators.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

300 participants in 40 patient groups

Irritable Bowel Syndrome
Experimental group
Description:
Fecal Microbiota Transplantation will be performed.
Treatment:
Procedure: Fecal Microbiota Transplantation
Constipation
Experimental group
Description:
Fecal Microbiota Transplantation will be performed.
Treatment:
Procedure: Fecal Microbiota Transplantation
Clostridium Difficile Infection
Experimental group
Description:
Fecal Microbiota Transplantation will be performed.
Treatment:
Procedure: Fecal Microbiota Transplantation
Functional Dyspepsia
Experimental group
Description:
Fecal Microbiota Transplantation will be performed.
Treatment:
Procedure: Fecal Microbiota Transplantation
Parkinson's Disease
Experimental group
Description:
Fecal Microbiota Transplantation will be performed.
Treatment:
Procedure: Fecal Microbiota Transplantation
Metabolic Syndrome
Experimental group
Description:
Fecal Microbiota Transplantation will be performed.
Treatment:
Procedure: Fecal Microbiota Transplantation
Non-Alcoholic Fatty Liver Disease
Experimental group
Description:
Fecal Microbiota Transplantation will be performed.
Treatment:
Procedure: Fecal Microbiota Transplantation
Autism Spectrum Disorder
Experimental group
Description:
Fecal Microbiota Transplantation will be performed.
Treatment:
Procedure: Fecal Microbiota Transplantation
Radiation Enteritis
Experimental group
Description:
Fecal Microbiota Transplantation will be performed.
Treatment:
Procedure: Fecal Microbiota Transplantation
Atopic Dermatitis
Experimental group
Description:
Fecal Microbiota Transplantation will be performed.
Treatment:
Procedure: Fecal Microbiota Transplantation
Food Allergic
Experimental group
Description:
Fecal Microbiota Transplantation will be performed.
Treatment:
Procedure: Fecal Microbiota Transplantation
Graft-versus-Host Disease
Experimental group
Description:
Fecal Microbiota Transplantation will be performed.
Treatment:
Procedure: Fecal Microbiota Transplantation
Obesity
Experimental group
Description:
Fecal Microbiota Transplantation will be performed.
Treatment:
Procedure: Fecal Microbiota Transplantation
Diabetes mellitus
Experimental group
Description:
Fecal Microbiota Transplantation will be performed.
Treatment:
Procedure: Fecal Microbiota Transplantation
Multi-Drug Resistant Infection
Experimental group
Description:
Fecal Microbiota Transplantation will be performed.
Treatment:
Procedure: Fecal Microbiota Transplantation
Hepatic Encephalopathy
Experimental group
Description:
Fecal Microbiota Transplantation will be performed.
Treatment:
Procedure: Fecal Microbiota Transplantation
Enteric Dysbacteriosis
Experimental group
Description:
Fecal Microbiota Transplantation will be performed.
Treatment:
Procedure: Fecal Microbiota Transplantation
Multiple Sclerosis
Experimental group
Description:
Fecal Microbiota Transplantation will be performed.
Treatment:
Procedure: Fecal Microbiota Transplantation
Pseudomembranous Enteritis
Experimental group
Description:
Fecal Microbiota Transplantation will be performed.
Treatment:
Procedure: Fecal Microbiota Transplantation
Acute Pancreatitis
Experimental group
Description:
Fecal Microbiota Transplantation will be performed.
Treatment:
Procedure: Fecal Microbiota Transplantation
Chronic Fatigue Syndrome
Experimental group
Description:
Fecal Microbiota Transplantation will be performed.
Treatment:
Procedure: Fecal Microbiota Transplantation
Acute-on-chronic Liver Failure with HBV Infection
Experimental group
Description:
Fecal Microbiota Transplantation will be performed.
Treatment:
Procedure: Fecal Microbiota Transplantation
Alcoholic Liver Disease
Experimental group
Description:
Fecal Microbiota Transplantation will be performed.
Treatment:
Procedure: Fecal Microbiota Transplantation
Anorexia
Experimental group
Description:
Fecal Microbiota Transplantation will be performed.
Treatment:
Procedure: Fecal Microbiota Transplantation
Decompensated Cirrhosis
Experimental group
Description:
Fecal Microbiota Transplantation will be performed.
Treatment:
Procedure: Fecal Microbiota Transplantation
Henoch-Schonlein Purpura
Experimental group
Description:
Fecal Microbiota Transplantation will be performed.
Treatment:
Procedure: Fecal Microbiota Transplantation
Autoimmune Liver Disease
Experimental group
Description:
Fecal Microbiota Transplantation will be performed.
Treatment:
Procedure: Fecal Microbiota Transplantation
Systemic Lupus Erythematosus
Experimental group
Description:
Fecal Microbiota Transplantation will be performed.
Treatment:
Procedure: Fecal Microbiota Transplantation
IgG4-Related Disease
Experimental group
Description:
Fecal Microbiota Transplantation will be performed.
Treatment:
Procedure: Fecal Microbiota Transplantation
Celiac Disease
Experimental group
Description:
Fecal Microbiota Transplantation will be performed.
Treatment:
Procedure: Fecal Microbiota Transplantation
Protein-losing Enteropathy
Experimental group
Description:
Fecal Microbiota Transplantation will be performed.
Treatment:
Procedure: Fecal Microbiota Transplantation
Asperger Syndrome
Experimental group
Description:
Fecal Microbiota Transplantation will be performed.
Treatment:
Procedure: Fecal Microbiota Transplantation
Rheumatoid arthritis
Experimental group
Description:
Fecal Microbiota Transplantation will be performed.
Treatment:
Procedure: Fecal Microbiota Transplantation
Ulcerative colitis
Experimental group
Description:
Fecal Microbiota Transplantation will be performed.
Treatment:
Procedure: Fecal Microbiota Transplantation
Crohn's disease
Experimental group
Description:
Fecal Microbiota Transplantation will be performed.
Treatment:
Procedure: Fecal Microbiota Transplantation
Psoriasis
Experimental group
Description:
Fecal Microbiota Transplantation will be performed.
Treatment:
Procedure: Fecal Microbiota Transplantation
Ankylosing spondylitis
Experimental group
Description:
Fecal Microbiota Transplantation will be performed.
Treatment:
Procedure: Fecal Microbiota Transplantation
Immune checkpoint inhibition-related colitis
Experimental group
Description:
Fecal Microbiota Transplantation will be performed.
Treatment:
Procedure: Fecal Microbiota Transplantation
Autoimmune enteropathy
Experimental group
Description:
Fecal Microbiota Transplantation will be performed.
Treatment:
Procedure: Fecal Microbiota Transplantation
Drug-induced diarrhea
Experimental group
Description:
Fecal Microbiota Transplantation will be performed.
Treatment:
Procedure: Fecal Microbiota Transplantation

Trial contacts and locations

1

Loading...

Central trial contact

Yongjian Zhou, MM; Hongli Huang, MM

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Research sites

Find research sitesLearn about CTV for professionals

Resources

Contact CTV support

Legal

Privacy NoticeTerms
© Copyright 2026 Veeva Systems