Efficacy and Safety of Fecal Microbiota Transplantation

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

Patrocinadores

Patrocinador principal: Guangzhou First People's Hospital

Fuente Guangzhou First People's Hospital
Resumen breve

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.

Estado general Not yet recruiting
Fecha de inicio March 1, 2021
Fecha de Terminación December 31, 2026
Fecha de finalización primaria December 31, 2025
Fase N/A
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
The efficacy of FMT in patients with gastrointestinal symptom will be assessed by the change of Gastrointestinal Symptom Rating Scale(GSRS). 1 year
Resultado secundario
Medida Periodo de tiempo
Number of Participants With Treatment-Related Adverse Events as Assessed by Common Terminology Criteria for Adverse Events(CTCAE) V4.0 1 year
Inscripción 300
Condición
Intervención

Tipo de intervención: Procedure

Nombre de intervención: Fecal Microbiota Transplantation

Descripción: Procedure: Fecal Microbiota Transplantation

Elegibilidad

Criterios:

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.

Género: All

Edad mínima: 18 Years

Edad máxima: 70 Years

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
Hongli Huang, MM Principal Investigator Guangzhou First People's Hospital
Contacto general

Apellido: Yongjian Zhou, MM

Teléfono: 86-13503060150

Email: [email protected]

Ubicación
Instalaciones: Contacto: Copia de seguridad de contactos: Investigador: Guangzhou First People's Hospital Yongjian Zhou, MM 86-13503060150 [email protected] Yandi Liu, MM Sub-Investigator
Ubicacion Paises

China

Fecha de verificación

January 2021

Fiesta responsable

Tipo: Sponsor

Tiene acceso ampliado No
Número de brazos 37
Grupo de brazo

Etiqueta: Irritable Bowel Syndrome

Tipo: Experimental

Descripción: Fecal Microbiota Transplantation will be performed.

Etiqueta: Constipation

Tipo: Experimental

Descripción: Fecal Microbiota Transplantation will be performed.

Etiqueta: Clostridium Difficile Infection

Tipo: Experimental

Descripción: Fecal Microbiota Transplantation will be performed.

Etiqueta: Functional Dyspepsia

Tipo: Experimental

Descripción: Fecal Microbiota Transplantation will be performed.

Etiqueta: Parkinson's Disease

Tipo: Experimental

Descripción: Fecal Microbiota Transplantation will be performed.

Etiqueta: Metabolic Syndrome

Tipo: Experimental

Descripción: Fecal Microbiota Transplantation will be performed.

Etiqueta: Non-Alcoholic Fatty Liver Disease

Tipo: Experimental

Descripción: Fecal Microbiota Transplantation will be performed.

Etiqueta: Autism Spectrum Disorder

Tipo: Experimental

Descripción: Fecal Microbiota Transplantation will be performed.

Etiqueta: Radiation Enteritis

Tipo: Experimental

Descripción: Fecal Microbiota Transplantation will be performed.

Etiqueta: Atopic Dermatitis

Tipo: Experimental

Descripción: Fecal Microbiota Transplantation will be performed.

Etiqueta: Food Allergic

Tipo: Experimental

Descripción: Fecal Microbiota Transplantation will be performed.

Etiqueta: Graft-versus-Host Disease

Tipo: Experimental

Descripción: Fecal Microbiota Transplantation will be performed.

Etiqueta: Obesity

Tipo: Experimental

Descripción: Fecal Microbiota Transplantation will be performed.

Etiqueta: Diabetes mellitus

Tipo: Experimental

Descripción: Fecal Microbiota Transplantation will be performed.

Etiqueta: Multi-Drug Resistant Infection

Tipo: Experimental

Descripción: Fecal Microbiota Transplantation will be performed.

Etiqueta: Hepatic Encephalopathy

Tipo: Experimental

Descripción: Fecal Microbiota Transplantation will be performed.

Etiqueta: Enteric Dysbacteriosis

Tipo: Experimental

Descripción: Fecal Microbiota Transplantation will be performed.

Etiqueta: Multiple Sclerosis

Tipo: Experimental

Descripción: Fecal Microbiota Transplantation will be performed.

Etiqueta: Pseudomembranous Enteritis

Tipo: Experimental

Descripción: Fecal Microbiota Transplantation will be performed.

Etiqueta: Acute Pancreatitis

Tipo: Experimental

Descripción: Fecal Microbiota Transplantation will be performed.

Etiqueta: Chronic Fatigue Syndrome

Tipo: Experimental

Descripción: Fecal Microbiota Transplantation will be performed.

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

Tipo: Experimental

Descripción: Fecal Microbiota Transplantation will be performed.

Etiqueta: Alcoholic Liver Disease

Tipo: Experimental

Descripción: Fecal Microbiota Transplantation will be performed.

Etiqueta: Anorexia

Tipo: Experimental

Descripción: Fecal Microbiota Transplantation will be performed.

Etiqueta: Decompensated Cirrhosis

Tipo: Experimental

Descripción: Fecal Microbiota Transplantation will be performed.

Etiqueta: Henoch-Schonlein Purpura

Tipo: Experimental

Descripción: Fecal Microbiota Transplantation will be performed.

Etiqueta: Autoimmune Liver Disease

Tipo: Experimental

Descripción: Fecal Microbiota Transplantation will be performed.

Etiqueta: Systemic Lupus Erythematosus

Tipo: Experimental

Descripción: Fecal Microbiota Transplantation will be performed.

Etiqueta: IgG4-Related Disease

Tipo: Experimental

Descripción: Fecal Microbiota Transplantation will be performed.

Etiqueta: Celiac Disease

Tipo: Experimental

Descripción: Fecal Microbiota Transplantation will be performed.

Etiqueta: Protein-losing Enteropathy

Tipo: Experimental

Descripción: Fecal Microbiota Transplantation will be performed.

Etiqueta: Asperger Syndrome

Tipo: Experimental

Descripción: Fecal Microbiota Transplantation will be performed.

Etiqueta: Rheumatoid arthritis

Tipo: Experimental

Descripción: Fecal Microbiota Transplantation will be performed.

Etiqueta: Ulcerative colitis

Tipo: Experimental

Descripción: Fecal Microbiota Transplantation will be performed.

Etiqueta: Crohn's disease

Tipo: Experimental

Descripción: Fecal Microbiota Transplantation will be performed.

Etiqueta: Psoriasis

Tipo: Experimental

Descripción: Fecal Microbiota Transplantation will be performed.

Etiqueta: Ankylosing spondylitis

Tipo: Experimental

Descripción: Fecal Microbiota Transplantation will be performed.

Acrónimo FMT
Datos del paciente No
Información de diseño del estudio

Asignación: Non-Randomized

Modelo de intervención: Parallel Assignment

Propósito primario: Treatment

Enmascaramiento: None (Open Label)

Fuente: ClinicalTrials.gov