The functional characteristics of intestinal microbiome in moderate-to-severe ulcerative colitis and the relationship with anti-TNF efficacy

Status

Recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2300071816

Enrollment

Unknown

Registered

2023-05-25

Start date

2022-09-01

Completion date

Unknown

Last updated

2023-06-12

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

Conditions

ulcerative colitis

Interventions

Moderate-Severe UC:N/A

Mild UC:N/A

Healthy control group:N/A

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Met the diagnosis of moderate to severe UC 2. No use of glucocorticoids, immunosuppressants, biological agents within 3 months, and no use of antibiotics within 1 week 3. No familial, metabolic, neoplastic, or psychiatric disorders. 4. The first-line biologic agent is IFX

Exclusion criteria

Exclusion criteria: 1. Children, pregnant women, lactation 2. Patients who could not tolerate colonoscopy and sigmoidoscopy 3. Patients with undetermined colitis for whom ulcerative colitis is initially diagnosed and Crohn's disease cannot be ruled out during subsequent care 4. Patients with fulminant acute severe ulcerative colitis

Design outcomes

Primary

Measure	Time frame
16s-rRNA;	—

Secondary

Measure	Time frame
Untargeted metabolomics;	—

Countries

China

Contacts

Public ContactZhang hongjie

Jiangsu Province Hospital

hjzhang06@163.com+86 139 5197 5918

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 23, 2026