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Clinical study of fecal microbiota transplantation in the treatment of intestinal microecological imbalance related diseases

Clinical study of fecal microbiota transplantation in the treatment of intestinal microecological imbalance related diseases

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200065777
Enrollment
Unknown
Registered
2022-11-15
Start date
2022-12-01
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Intestinal microecological imbalance related diseases

Interventions

FMT treatment group:fecal microbiota transplantation

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1. Donor selection criteria: (1) Voluntarily participate in the test and sign the informed consent; (2) Aged 18-55 years, no gender limit; (3) No medication (such as antibiotics, antiviral, antifungal drugs, hormones, immunosuppressants, chemotherapy drugs, diet drugs, etc.) for nearly 6 months. Except birth control pills); (4) No high-risk sexual behavior (such as sexual contact with HIV patients, drug users, syphilis, etc.) in the past 6 months; (5) No tattoo or piercing; (6) No history of infectious diseases (such as hepatitis, syphilis, HIV, tuberculosis, malaria, schistosomiasis, etc.) or history of travel to epidemic areas; (7) No acute or chronic intestinal diseases (such as acute or chronic enteritis, functional bowel disease, inflammatory bowel disease, intestinal polyps or malignant tumors, etc.); (8) No blood transfusion; No history of drug use; Regular bowel movements are regular, formed and smooth. 2. Acceptance criteria: (1) Voluntarily participate in the test and sign the informed consent; (2) Intestinal diseases associated with intestinal microecological imbalance that have been clearly diagnosed include pseudomememonitis CDI, antibiotic-associated diarrhea, irritable bowel syndrome, ulcerative colitis, Crohn's disease, intractable constipation, and radiation enteritis; (3) Parenteral diseases associated with intestinal microecological imbalance that have been clearly diagnosed include non-alcoholic fatty liver disease, childhood autism, Parkinson's disease, metabolic diseases, and intestinal complications of organ transplantation.

Exclusion criteria

Exclusion criteria: 1. Donor exclusion criteria: (1) BMI>=28 kg/m^2 or BMI<=18 kg/m^2; (2) Atopic diseases (such as allergic rhinitis, allergic asthma, atopic dermatitis, etc.); (3) Depression, anxiety and other mental diseases; Diseases requiring maintenance treatment with drugs; (4) Chronic diseases (such as cirrhosis, diabetes, hypertension, coronary heart disease, asthma, chronic obstructive pulmonary disease, etc.); (5) Diseases of the nervous system or nervous system degeneration; (6) Autoimmune diseases (e.g., celiac disease, arthritis, multiple sclerosis, connective tissue disease, psoriasis); (7) History of gastrointestinal surgery (except appendectomy); (8) Family history of the following diseases (siblings and parents) : Crohn's disease, ulcerative colitis, celiac disease, colorectal cancer, polyposis, diabetes, psycho-psychological disorders, and other genetic disorders; (9) Gastrointestinal discomfort in the last 1 month: such as any moderate to severe upper gastrointestinal discomfort, diarrhea, constipation, moderate to severe abdominal distension, moderate to severe nausea, painful defecation, fecal mucus, blood in the stool or any blood signs related to defecation; (10) Have a history of diarrhea and intestinal lavage in the past 3 months. 2. Exclusion criteria for receptors: (1) Contraindications for gastroenteroscopy and mucosal biopsy, such as severe malnutrition or severe immune deficiency, coagulopathy, oral anticoagulants, severe damage of intestinal mucosa, complicated with severe infection, acute myocardial infarction, respiratory failure, etc.; (2) Can not cooperate with clinical follow-up; (3) Pregnant or lactating patients in the medical history.

Design outcomes

Primary

MeasureTime frame
Relief of clinical symptoms;

Secondary

MeasureTime frame
Alterations in the intestinal microbiota;

Countries

China

Contacts

Public ContactLiu Ling

West China Hospital, Sichuan University

18980606772@163.com+86 18980606772

Outcome results

None listed

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