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A clinical study for the clinical efficacy and safety of fecal microbiota transplantation in patients with ulcerative colitis

A clinical study for the clinical efficacy and safety of fecal microbiota transplantation in patients with ulcerative colitis

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900022273
Enrollment
Unknown
Registered
2019-04-02
Start date
2018-04-01
Completion date
Unknown
Last updated
2019-04-08

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

Conditions

ulcerative colitis

Interventions

Group A:fecal microbiota transplantation

Sponsors

Department of Gastroenterology, the First Affiliated Hospital of Anhui Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
14 Years to 70 Years

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

MeasureTime 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

Public ContactXi Chen

Department of Gastroenterology, the First Affiliated Hospital of Anhui Medical University

ayfychenxi@163.com+86 13965038586

Outcome results

None listed

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