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

Fecal Microbiota Transplantation

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

Number Of Arms

Arm Group

Label: Irritable Bowel Syndrome

Type: Experimental