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Efficacy and Safety of Fecal Microbiota Transplantation (FMT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04706611
Recruitment Status : Recruiting
First Posted : January 13, 2021
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
Guangzhou First People's Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Fecal Microbiota Transplantation Procedure: Fecal Microbiota Transplantation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Fecal Microbiota Transplantation in Patients With Intestinal Dysbiosis -A Pilot Study
Actual Study Start Date : January 15, 2021
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arm Intervention/treatment
Experimental: Irritable Bowel Syndrome
Fecal Microbiota Transplantation will be performed.
Procedure: Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation

Experimental: Constipation
Fecal Microbiota Transplantation will be performed.
Procedure: Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation

Experimental: Clostridium Difficile Infection
Fecal Microbiota Transplantation will be performed.
Procedure: Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation

Experimental: Functional Dyspepsia
Fecal Microbiota Transplantation will be performed.
Procedure: Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation

Experimental: Parkinson's Disease
Fecal Microbiota Transplantation will be performed.
Procedure: Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation

Experimental: Metabolic Syndrome
Fecal Microbiota Transplantation will be performed.
Procedure: Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation

Experimental: Non-Alcoholic Fatty Liver Disease
Fecal Microbiota Transplantation will be performed.
Procedure: Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation

Experimental: Autism Spectrum Disorder
Fecal Microbiota Transplantation will be performed.
Procedure: Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation

Experimental: Radiation Enteritis
Fecal Microbiota Transplantation will be performed.
Procedure: Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation

Experimental: Atopic Dermatitis
Fecal Microbiota Transplantation will be performed.
Procedure: Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation

Experimental: Food Allergic
Fecal Microbiota Transplantation will be performed.
Procedure: Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation

Experimental: Graft-versus-Host Disease
Fecal Microbiota Transplantation will be performed.
Procedure: Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation

Experimental: Obesity
Fecal Microbiota Transplantation will be performed.
Procedure: Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation

Experimental: Diabetes mellitus
Fecal Microbiota Transplantation will be performed.
Procedure: Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation

Experimental: Multi-Drug Resistant Infection
Fecal Microbiota Transplantation will be performed.
Procedure: Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation

Experimental: Hepatic Encephalopathy
Fecal Microbiota Transplantation will be performed.
Procedure: Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation

Experimental: Enteric Dysbacteriosis
Fecal Microbiota Transplantation will be performed.
Procedure: Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation

Experimental: Multiple Sclerosis
Fecal Microbiota Transplantation will be performed.
Procedure: Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation

Experimental: Pseudomembranous Enteritis
Fecal Microbiota Transplantation will be performed.
Procedure: Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation

Experimental: Acute Pancreatitis
Fecal Microbiota Transplantation will be performed.
Procedure: Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation

Experimental: Chronic Fatigue Syndrome
Fecal Microbiota Transplantation will be performed.
Procedure: Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation

Experimental: Acute-on-chronic Liver Failure with HBV Infection
Fecal Microbiota Transplantation will be performed.
Procedure: Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation

Experimental: Alcoholic Liver Disease
Fecal Microbiota Transplantation will be performed.
Procedure: Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation

Experimental: Anorexia
Fecal Microbiota Transplantation will be performed.
Procedure: Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation

Experimental: Decompensated Cirrhosis
Fecal Microbiota Transplantation will be performed.
Procedure: Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation

Experimental: Henoch-Schonlein Purpura
Fecal Microbiota Transplantation will be performed.
Procedure: Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation

Experimental: Autoimmune Liver Disease
Fecal Microbiota Transplantation will be performed.
Procedure: Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation

Experimental: Systemic Lupus Erythematosus
Fecal Microbiota Transplantation will be performed.
Procedure: Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation

Experimental: IgG4-Related Disease
Fecal Microbiota Transplantation will be performed.
Procedure: Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation

Experimental: Celiac Disease
Fecal Microbiota Transplantation will be performed.
Procedure: Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation

Experimental: Protein-losing Enteropathy
Fecal Microbiota Transplantation will be performed.
Procedure: Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation

Experimental: Asperger Syndrome
Fecal Microbiota Transplantation will be performed.
Procedure: Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation

Experimental: Rheumatoid arthritis
Fecal Microbiota Transplantation will be performed.
Procedure: Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation

Experimental: Ulcerative colitis
Fecal Microbiota Transplantation will be performed.
Procedure: Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation

Experimental: Crohn's disease
Fecal Microbiota Transplantation will be performed.
Procedure: Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation

Experimental: Psoriasis
Fecal Microbiota Transplantation will be performed.
Procedure: Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation

Experimental: Ankylosing spondylitis
Fecal Microbiota Transplantation will be performed.
Procedure: Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation

Experimental: Immune checkpoint inhibition-related colitis
Fecal Microbiota Transplantation will be performed.
Procedure: Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation

Experimental: Autoimmune enteropathy
Fecal Microbiota Transplantation will be performed.
Procedure: Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation

Experimental: Drug-induced diarrhea
Fecal Microbiota Transplantation will be performed.
Procedure: Fecal Microbiota Transplantation
Procedure: Fecal Microbiota Transplantation




Primary Outcome Measures :
  1. The efficacy of FMT in patients with gastrointestinal symptom will be assessed by the change of Gastrointestinal Symptom Rating Scale(GSRS). [ Time Frame: 1 year ]
    Gastrointestinal Symptom Rating Scale(GSRS) is a measure of gastrointestinal symptom severity in five clusters (pain, bloating, constipation, diarrhea, and early satiety).The items are scored between 1 and 7, where 1 corresponds to "no discomfort at all" and 7 to "very severe discomfort" from the symptom. The participants will be asked to filled in the scale in several time points from baseline to 12 months after FMT.


Secondary Outcome Measures :
  1. Number of Participants With Treatment-Related Adverse Events as Assessed by Common Terminology Criteria for Adverse Events(CTCAE) V4.0 [ Time Frame: 1 year ]

Other Outcome Measures:
  1. Numbers of patients who have improvement in clinical symptoms (depends on each disease as stated in outcome) [ Time Frame: 1 year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04706611


Contacts
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Contact: Yongjian Zhou, MM 86-13503060150 eyzhouyongjian@scut.edu.cn
Contact: Hongli Huang, MM 86-13631316718 honglisums@126.com

Locations
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China, Guangdong
Guangzhou First People's Hospital Recruiting
Guangzhou, Guangdong, China, 510180
Contact: Yongjian Zhou, MM    86-13503060150    eyzhouyongjian@scut.edu.cn   
Contact: Hongli Huang, MM    86-13631316718    honglisums@126.com   
Sub-Investigator: Yandi Liu, MM         
Sponsors and Collaborators
Guangzhou First People's Hospital
Investigators
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Principal Investigator: Hongli Huang, MM Guangzhou First People's Hospital
Publications:

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Responsible Party: Guangzhou First People's Hospital
ClinicalTrials.gov Identifier: NCT04706611    
Other Study ID Numbers: B-2019-041-01
First Posted: January 13, 2021    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No