Efficacy and Safety of Fecal Microbiota Transplantation

Not Applicable

Recruiting

• Conditions: Fecal Microbiota Transplantation

• Registration Number: NCT04706611
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-20
• Study First Submitted QC: 2021-01-10
• Study First Posted: 2021-01-13
• Study Start: 2021-01-15
• Status Verified: 2021-02
• Last Update Submitted: 2021-04-06
• Last Update Posted: 2021-04-08
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The efficacy of FMT in patients with gastrointestinal symptom will be assessed by the change of Gastrointestinal Symptom Rating Scale(GSRS).	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

Name	Time	Method
Number of Participants With Treatment-Related Adverse Events as Assessed by Common Terminology Criteria for Adverse Events(CTCAE) V4.0	1 year

Trial Locations

Locations (1)

Guangzhou First People's Hospital; 🇨🇳 Guangzhou, Guangdong, China