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Clinical efficacy of fecal microbiota transplantation capsule combined with vedolizumab in the treatment of moderate-to-severe ulcerative colitis and its influence on gut microbiota.

Clinical efficacy of fecal microbiota transplantation capsule combined with vedolizumab in the treatment of moderate-to-severe ulcerative colitis and its influence on gut microbiota.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078543
Enrollment
Unknown
Registered
2023-12-12
Start date
2023-12-12
Completion date
Unknown
Last updated
2023-12-19

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

Conditions

ulcerative colitis

Interventions

Test group:fecal microbiota transplantation capsule

Sponsors

Army Medical Center(Daping Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Male or female, adults aged 18-75. 2.Patients who meet the diagnostic criteria for UC in the Consensus Opinion on the Diagnosis and Treatment of Inflammatory Bowel Disease (2018 • Beijing). 3.Poor response to conventional drugs (including 5-aminosalicylic acid, corticosteroids, immunosuppressants), the modified Mayo score ranges from 6 to 12, and the modified Truelove and Witts disease severity scores are moderate to severe. 4.Patients who voluntarily agree to participate in this study and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1.Patients with other serious diseases, such as respiratory failure, heart failure, severe immunodeficiency, indications for surgery, or a history of colon surgery. 2.Patients with a history of combined diseases that affect the gut microbiota, such as metabolic syndrome and autoimmune diseases. 3.Women in the preparation, pregnancy, or lactation period. 4.Use antibiotics or probiotics within 1 week before enrollment. 5.Patients with contraindications to gastrointestinal endoscopy or a history of severe allergies. 6.Patients undergoing other clinical studies within 4 week before enrollment. 7.Patients with poor compliance and difficulty in completing follow-up. 8.Other reasons that researchers think are not suitable for enrollment or patients withdrawing from the trial due to their own reasons.

Design outcomes

Primary

MeasureTime frame
Simple Clinical Colitis Activity Index;

Secondary

MeasureTime frame
Modified MAYO Score;biomarkers;Mucosal healing rate;Change in gut microbiota;

Countries

China

Contacts

Public ContactYanling Wei

Army Medical Center(Daping Hospital)

lingzi016@126.com+86 153 1035 4666

Outcome results

None listed

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