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Fecal Microbiota Transplantation in the treatment of moderate to severe ulcerative colitis

A randomized, double blinded, controlled, multi-center study of Fecal Microiota Transplantation (FMT) for the treatment of moderate to severe Ulcerative Colitis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-INR-16010151
Enrollment
Unknown
Registered
2016-12-14
Start date
2016-12-14
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Ulcerative Colitis

Interventions

Sponsors

Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-70 years; 2. Established UC according to the Lennard-Jones criteria; 3. Moderate to severe UC Mayo Scores= 6; 4. Refusing taking glucocorticoids after treatments with full dose of 5-aminosalicylic acid (4g/d) for at least 4 weeks and disease remained active; glucocorticoids dependence; 5. Ability to give informed consent; Willing and able to participate in the study requirements, including serial stool collection, survey completion and clinic visits; 6. Without any antibiotic, probiotics or prebiotics use within the last 4 weeks.

Exclusion criteria

Exclusion criteria: Proctitis; Have other intestinal diseases: for example: bowel obstruction, perforation and/or abscess; Concurrent Clostridium difficile infection or other known infection; Any antibiotic, probiotics or prebiotics use within the last 1 months; Taking any immunosuppressive agents within 8 weeks; Pregnancy, lactation or plan to conceive within 1 year.

Design outcomes

Primary

MeasureTime frame
Mayo Scores;Endoscopic Mayo scores;remission rate;

Secondary

MeasureTime frame
adverse reactions;laboratory indexes;The structural and quantity alterations of intestinal flora pre- and after fecal transplantation;

Countries

China

Contacts

Public ContactYunsheng Yang

Chinese PLA General Hosipital

sunny301ddc@126.com+86 010 55499005

Outcome results

None listed

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