Skip to content

Clinical trial for fecal bacteria transplantation in the treatment of active inflammatory bowel disease

Clinical trial for fecal bacteria transplantation in the treatment of active inflammatory bowel disease

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000030080
Enrollment
Unknown
Registered
2020-02-22
Start date
2020-07-16
Completion date
Unknown
Last updated
2020-07-27

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

Conditions

Inflammatory bowel disease

Interventions

control group:conventional therapy

Sponsors

Department of Gastroenteroly, the Second Hosptial of Anhui Medical Univerisity
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Inclusion criteria for patients with ulcerative colitis: (1) Patients with recurrent ulcerative colitis in the active period were diagnosed; (2) Older than 18-75, regardless of gender; (3) The patient has received a stable combined dose (aminosalicylic acid preparation) for at least 4 weeks; (4) No history of antibiotics, probiotics or probiotics in at least one month; (5) No history of intestinal preparation before colonoscopy for at least one month; (6) Voluntarily participate in this clinical trial and sign the informed consent; (7) The patient is willing to accept later follow-up and other protocol requirements. 2. Inclusion criteria for crohn patients: (1) Diagnosis of active relapsing Crohn disease; (2) Older than 18-75, regardless of gender; (3) The patient has received a stable combined dose (aminosalicylic acid preparation) for at least 4 weeks; (4) No history of antibiotics, probiotics or probiotics in at least one month.

Exclusion criteria

Exclusion criteria: 1. Women who have a pregnancy plan during pregnancy or the trial period; 2. Patients have any doubts about the technology or have a history of other risks; 3. The patient is in the terminal stage of the disease or may die in the study; 4. The patient had a history of antibiotic use three months before the transplant or participated in other clinical trials; 5. Have participated in any other bacterial community treatment before inclusion; 6. Hepatitis b, tuberculosis, syphilis and HIV antibody positive or any infectious disease or infectious disease acute phase; 7. Cardiac function III level and above, more than twice the upper limit of normal transaminase eleations, renal insufficiency glomerular filtration rate (GFR below 60 ml/min). 8. Febrile temperature above 38 degrees C or clinically significant active infection that can affect this study; 9. Severe anemia (hemoglobin < 60g/L), granulocytopenia (absolute value of neutrophils < 1.5 x 10^9/L), and prolonged PT for more than 1.5 seconds; 10. Significant cardiovascular and cerebrovascular abnormalities (such as tachycardia or uncontrolled atrial fibrillation, acute coronary syndrome, stroke or recurrent TIA attacks); History of arrhythmia (polygenic preventricular contractile, tri, tri, congenital long QT syndrome) or heart disease that increases the risk of ventricular arrhythmia as determined by the investigator; 11. Conditions identified by the investigator during the trial that may affect the subject's compliance and/or completion of trial-related procedures, or clinical contraindications related to the pre-trial; 12. The patients underwent abdominal viscera surgery three months before the fecal bacteria transplantation, and the patients were less than 6 weeks after the main viscera surgery, and the surgical wound healing was poor. 13. Patients with gastrointestinal obstructive diseases, tumors, and liver and kidney dysfunction; 14. Pregnant or nursing women or women with pregnancy intention; 15. Suspected or confirmed drug abusers, with a history of immunodeficiency (HIV antibody positive or receiving immunosuppressive therapy, etc.); 16. A major active infection is known, or a major disturbance of blood, kidney, metabolism, gastrointestinal or endocrine function is determined by the investigator 17. Staff of the research centre;The partner or first-degree relative of the researcher; 18. Other conditions considered inappropriate for inclusion by the investigator.

Design outcomes

Primary

MeasureTime frame
Efficacy (the primary endpoint was clinical and mucosal remission);

Secondary

MeasureTime frame
Intestinal flora;adverse reactions;

Countries

China

Contacts

Public ContactFang haiming

The Second Hosptial of Anhui Medical Univerisity

haimingfang@ahmu.edu.cn+86 551-65997068

Outcome results

None listed

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