Efficacy and Safety of Fecal Microbiota Transplantation

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

Sponsors

Lead Sponsor: Guangzhou First People's Hospital

Source 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.

Overall Status Not yet recruiting
Start Date March 1, 2021
Completion Date December 31, 2026
Primary Completion Date December 31, 2025
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
The efficacy of FMT in patients with gastrointestinal symptom will be assessed by the change of Gastrointestinal Symptom Rating Scale(GSRS). 1 year
Secondary Outcome
Measure Time Frame
Number of Participants With Treatment-Related Adverse Events as Assessed by Common Terminology Criteria for Adverse Events(CTCAE) V4.0 1 year
Enrollment 300
Condition
Intervention

Intervention Type: Procedure

Intervention Name: Fecal Microbiota Transplantation

Description: Procedure: Fecal Microbiota Transplantation

Eligibility

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 - 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.

Gender: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Hongli Huang, MM Principal Investigator Guangzhou First People's Hospital
Overall Contact

Last Name: Yongjian Zhou, MM

Phone: 86-13503060150

Email: [email protected]

Location
Facility: Contact: Contact Backup: Investigator: Guangzhou First People's Hospital Yongjian Zhou, MM 86-13503060150 [email protected] Yandi Liu, MM Sub-Investigator
Location Countries

China

Verification Date

January 2021

Responsible Party

Type: Sponsor

Has Expanded Access No
Number Of Arms 37
Arm Group

Label: Irritable Bowel Syndrome

Type: Experimental

Description: Fecal Microbiota Transplantation will be performed.

Label: Constipation

Type: Experimental

Description: Fecal Microbiota Transplantation will be performed.

Label: Clostridium Difficile Infection

Type: Experimental

Description: Fecal Microbiota Transplantation will be performed.

Label: Functional Dyspepsia

Type: Experimental

Description: Fecal Microbiota Transplantation will be performed.

Label: Parkinson's Disease

Type: Experimental

Description: Fecal Microbiota Transplantation will be performed.

Label: Metabolic Syndrome

Type: Experimental

Description: Fecal Microbiota Transplantation will be performed.

Label: Non-Alcoholic Fatty Liver Disease

Type: Experimental

Description: Fecal Microbiota Transplantation will be performed.

Label: Autism Spectrum Disorder

Type: Experimental

Description: Fecal Microbiota Transplantation will be performed.

Label: Radiation Enteritis

Type: Experimental

Description: Fecal Microbiota Transplantation will be performed.

Label: Atopic Dermatitis

Type: Experimental

Description: Fecal Microbiota Transplantation will be performed.

Label: Food Allergic

Type: Experimental

Description: Fecal Microbiota Transplantation will be performed.

Label: Graft-versus-Host Disease

Type: Experimental

Description: Fecal Microbiota Transplantation will be performed.

Label: Obesity

Type: Experimental

Description: Fecal Microbiota Transplantation will be performed.

Label: Diabetes mellitus

Type: Experimental

Description: Fecal Microbiota Transplantation will be performed.

Label: Multi-Drug Resistant Infection

Type: Experimental

Description: Fecal Microbiota Transplantation will be performed.

Label: Hepatic Encephalopathy

Type: Experimental

Description: Fecal Microbiota Transplantation will be performed.

Label: Enteric Dysbacteriosis

Type: Experimental

Description: Fecal Microbiota Transplantation will be performed.

Label: Multiple Sclerosis

Type: Experimental

Description: Fecal Microbiota Transplantation will be performed.

Label: Pseudomembranous Enteritis

Type: Experimental

Description: Fecal Microbiota Transplantation will be performed.

Label: Acute Pancreatitis

Type: Experimental

Description: Fecal Microbiota Transplantation will be performed.

Label: Chronic Fatigue Syndrome

Type: Experimental

Description: Fecal Microbiota Transplantation will be performed.

Label: Acute-on-chronic Liver Failure with HBV Infection

Type: Experimental

Description: Fecal Microbiota Transplantation will be performed.

Label: Alcoholic Liver Disease

Type: Experimental

Description: Fecal Microbiota Transplantation will be performed.

Label: Anorexia

Type: Experimental

Description: Fecal Microbiota Transplantation will be performed.

Label: Decompensated Cirrhosis

Type: Experimental

Description: Fecal Microbiota Transplantation will be performed.

Label: Henoch-Schonlein Purpura

Type: Experimental

Description: Fecal Microbiota Transplantation will be performed.

Label: Autoimmune Liver Disease

Type: Experimental

Description: Fecal Microbiota Transplantation will be performed.

Label: Systemic Lupus Erythematosus

Type: Experimental

Description: Fecal Microbiota Transplantation will be performed.

Label: IgG4-Related Disease

Type: Experimental

Description: Fecal Microbiota Transplantation will be performed.

Label: Celiac Disease

Type: Experimental

Description: Fecal Microbiota Transplantation will be performed.

Label: Protein-losing Enteropathy

Type: Experimental

Description: Fecal Microbiota Transplantation will be performed.

Label: Asperger Syndrome

Type: Experimental

Description: Fecal Microbiota Transplantation will be performed.

Label: Rheumatoid arthritis

Type: Experimental

Description: Fecal Microbiota Transplantation will be performed.

Label: Ulcerative colitis

Type: Experimental

Description: Fecal Microbiota Transplantation will be performed.

Label: Crohn's disease

Type: Experimental

Description: Fecal Microbiota Transplantation will be performed.

Label: Psoriasis

Type: Experimental

Description: Fecal Microbiota Transplantation will be performed.

Label: Ankylosing spondylitis

Type: Experimental

Description: Fecal Microbiota Transplantation will be performed.

Acronym FMT
Patient Data No
Study Design Info

Allocation: Non-Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov