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NCT Number: NCT04706611

Efficacy and Safety of Fecal Microbiota Transplantation

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.

Recruiting

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Key information

Conditions

Fecal Microbiota Transplantation

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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 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.

Treatment and study plan

Fecal Microbiota Transplantation

Procedure

Procedure: Fecal Microbiota Transplantation

Primary outcomes

  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 outcomes

  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 outcomes

  1. Numbers of patients who have improvement in clinical symptoms (depends on each disease as stated in outcome)

    Time frame: 1 year

Study contacts

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

Hongli Huang, MM

CONTACT

[email protected]

86-13631316718

Yongjian Zhou, MM

CONTACT

[email protected]

86-13503060150

Sponsors and collaborators

Lead sponsor

Guangzhou First People's Hospital

Other

Registry information

Official study title

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

Acronym: FMT

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Jan 13, 2021
Registry last updated
Apr 8, 2021

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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