ulcerative colitis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) The patient or his or her family (guardian) agrees to participate in the study and sign an informed consent form;(2) Aged 14-70 years, regardless of gender;(3) clinically diagnosed as refractory ulcerative colitis and meet the diagnostic criteria;(4) The Mayo score of ulcerative colitis activity is 4-10 points;(5) The patient receives a stable combined dose (aminosalicylic acid preparation, oral glucocorticoid) for at least 4 weeks; (6) the patient is willing to undergo follow-up and other protocol requirements.
Exclusion criteria
Exclusion criteria: (1) Patients who have a pregnancy plan during pregnancy or during the trial;(2) Patients who have any doubts about this technique or who have a history of other risks;(3) Patients at the end of the disease or who may have died in the study;(4) Study patients who participated in other clinical trials in the first three months of enrollment;(5) Study patients who have participated in any other flora treatment before enrollment;(6) Patients with historic megacolon;(7) Patients with severe cardiopulmonary, hepatic and renal insufficiency;(8) Patients with hepatitis B, tuberculosis, syphilis and HIV antibody positive;(9) Patients with severe anemia (Hb<6g/dl), multiple lymphadenopathy , and leukopenia;(10) Any patient considered by the investigator to be unable to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ulcer colitis Mayo score;Intestinal and oral 16S rDNA sequencing;Enteric mucosal pathology;Immunological indicators;Erythrocyte sedimentation rate;C-reactive protein;Fecal calprotectin; | — |
Countries
China
Contacts
Department of Gastroenterology, the First Affiliated Hospital of Anhui Medical University