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Observation of intestinal flora transplant for the treatment of infectious disease treatment

Observation of intestinal flora transplant for the treatment of infectious disease treatment

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400083171
Enrollment
Unknown
Registered
2024-04-17
Start date
2024-05-01
Completion date
Unknown
Last updated
2024-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

infectious disease

Interventions

The experimental group of patients with viral hepatitis A :Intestinal flora transplantation
The control group of patients with viral hepatitis A :Placebo
The experimental group of patients with viral hepatitis B :Intestinal flora transplantation
The control group of patients with viral hepatitis B:Placebo
The experimental group of patients with viral hepatitis C:Intestinal flora transplantation
The control group of patients with viral hepatitis C:Placebo
The experimental group of patients with AIDS:Intestinal flora transplantation
The control group of patients with AIDS:Placebo

Sponsors

Wuxi No.2 People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Patients: A) =18 years old; An infectious disease was diagnosed. Diagnostic criteria for infectious diseases: a) Clinically diagnosed cases, confirmed cases, pathogen carriers. The diseases requiring reporting pathogen carriers included cholera, polio and other infectious diseases stipulated by the National Health and Family Planning Commission of the People's Republic of China. b)Infectious diseases were diagnosed based on comprehensive analysis of epidemiology, clinical symptoms, signs, and laboratory tests. B) voluntarily participated in the study; C) being conscious; D) Able to communicate in language normally. Donors: (1) Healthy adults aged 18-30 years with no intestinal bacterial or fungal infectious diseases in the past three years, healthy work and rest, no bad living habits such as staying up late, and no use of antibiotics, probiotics or immunomodulators in the past six months; (2) no history of drug and food allergy or long-term medication; (3) no underlying diseases, autoimmune diseases, infectious diseases and other disease states.

Exclusion criteria

Exclusion criteria: (1) Suffering from severe cardiovascular and cerebrovascular diseases, respiratory system diseases, immune system diseases, and severe liver and kidney damage; (2) Suffering from severe mental illness, such as depression, generalized anxiety disorder, etc.; (3) Patients with intestinal infection or other infectious diseases; (4) Patients with allergic reactions to gut microbiota transplantation; (5) Patients with intestinal tumors or other intestinal diseases; (6) Patients who fail to provide complete medical history or examination data; (7) For various reasons, the study could not be carried out. (8) Those with fever, pregnancy, lactation, severe systemic infection, etc.; (9) Use of antibiotics in the past 2 weeks; (10) Use of probiotics or immunomodulators in the past month.

Design outcomes

Primary

MeasureTime frame
Titers of infectious disease indicators;Expand quantitative culture;16S rRNA sequencing;metagenome;basic information of patients;

Secondary

MeasureTime frame
blood routine examination;liver function;renal function;

Countries

China

Contacts

Public ContactFeng Ninghan

Wuxi No.2 People's Hospital

fnh888@njmu.edu.cn+86 138 1395 2696

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026