Analysis of intestinal microbiome in patients with tumor immunotherapy related colitis

Protective effects and mechanism of Lactobacillus rhamnosus and its main protein P40 in tumor immunotherapy-related colitis

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2000032088

Enrollment

Unknown

Registered

2020-04-19

Start date

2020-05-01

Completion date

Unknown

Last updated

2021-12-06

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

Conditions

Tumor immunotherapy related colitis

Interventions

Tumor immuno-therapy related colitis group:N/A

Non tumor immuno-therapy related colitis group:N/A

Tumor immuno-theray related colitis pre-treatment:N/A

Tumor immuno-theray related colitis post-treatment:N/A

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) Aged >=18 years, regardless of gender; 2) Patients diagnosed with non-small cell lung cancer and receiving anti-PD-1 immunotherapy; 3) IrAE colitis appears after receiving anti-PD-1 immunotherapy; 4) Subjects signed an informed consent in writing and volunteered to participate in this study.

Exclusion criteria

Exclusion criteria: 1) Vital signs unstable; 2) Patients with Gastrointestinal obstruction, gastrointestinal bleeding, or septic shock; 3) Patients who already had colitis before receiving anti-PD-1 immunotherapy; 4) Patients with infectious enteritis; 5) Need antibiotics treatment; 6) Pregnancy and lactation.

Design outcomes

Primary

Measure	Time frame
Fecal microbiome;	—

Countries

China

Contacts

Public ContactTan Bei

Peking Union Medical College Hospital, Chinese Academy of Medical Science & Peking Union Medical College

tanbei0626@aliyun.com+86 13601221869

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026