Efficacy and Safety of Fecal Microbiota Transplantation (FMT)

April 6, 2021 updated by: Guangzhou First People's Hospital

Efficacy and Safety of Fecal Microbiota Transplantation in Patients With Intestinal Dysbiosis -A Pilot Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510180
        • Recruiting
        • Guangzhou First People's Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Yandi Liu, MM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Number of Participants With Treatment-Related Adverse Events as Assessed by Common Terminology Criteria for Adverse Events(CTCAE) V4.0
Time Frame: 1 year
1 year

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Numbers of patients who have improvement in clinical symptoms (depends on each disease as stated in outcome)
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Guangzhou First People's Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hongli Huang, MM, Guangzhou First People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 20, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 13, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 8, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B-2019-041-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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