Mild to Moderate Ulcerative Colitis
Conditions
Interventions
Donor-Optimized FMT Combined with Biologic Therapy Group:FMT Combined with Biologic Therapy
Biologic Therapy Group:NA
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.a. Patients meeting the diagnostic criteria for ulcerative colitis (UC) with a confirmed diagnosis for more than 3 months. b. Patients with mild to moderate active UC, as defined by a modified Mayo score. c. Patients who have undergone 26 weeks of standardized biologic therapy, achieving clinical remission but not endoscopic remission. Clinical remission: Mayo subscores for rectal bleeding and stool frequency <= 1. Endoscopic remission: Endoscopic Mayo score = 0. d. Age between 18 and 70 years. e. Not currently enrolled in any other research study. f. Possessing good memory and mobility. g. Psychologically stable and capable of independent living. h. Willing to participate in this study and having signed the informed consent form. i. Demonstrating good adherence to the study protocol. A personally signed and dated informed consent form indicates that the patient (or legally authorized representative) has been fully informed about all relevant aspects of the study.
Exclusion criteria
Exclusion criteria: 1.a. Fulminant ulcerative colitis (UC). b. Patients who have undergone 26 weeks of standardized biologic therapy and achieved both clinical and endoscopic remission. Clinical remission: Mayo subscores for rectal bleeding and stool frequency <= 1. Endoscopic remission: Endoscopic Mayo score = 0. c. Patients planning to undergo surgical intervention. d. Concurrent use of antibiotics or probiotics. e. Severe anemia (Hb < 6 g/dL). f. Graft-versus-host disease (GVHD). g. Immunocompromised individuals with leukopenia or a history of opportunistic infections. h. History of abdominal surgery within the past 3 months. i. Participation in another clinical drug trial within the past month. j. Presence of acute infectious colitis confirmed by stool culture, toxin enzyme immunoassay, or immunohistochemistry, including infections with Shigella spp., Campylobacter jejuni, Salmonella spp., Aeromonas spp., Escherichia coli, Yersinia spp., cytomegalovirus (CMV), or non-infectious colitis. k. Amoebic colitis, intestinal schistosomiasis, intestinal tuberculosis, fungal enteritis, antibiotic-associated colitis (including pseudomembranous colitis), Henoch-Schönlein purpura, collagenous colitis, Behçet’s disease, colonic polyposis, colonic diverticulosis, or colonic lesions associated with human immunodeficiency virus (HIV) infection. l. UC patients with Clostridioides difficile infection. m. Patients with severe organic diseases such as cancer, coronary artery disease, myocardial infarction, or stroke. n. Individuals with physical disabilities or conditions impairing self-care, memory, or communication. o. Patients with significant motor dysfunction. p. Patients unable to commit sufficient time to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Remission + Endoscopic Remission; | — |
Secondary
| Measure | Time frame |
|---|---|
| Inflammatory Markers;Nutritional Status;Fecal Calprotectin;Standard of Living;Adverse Reaction; | — |
Countries
China
Contacts
Public ContactYue Zeng
Shanghai General Hospital
Outcome results
None listed