The Application of Probiotics in Patients with Advanced Gastric Malignancies Undergoing Anti-PD-1 Monoclonal Antibody Immunotherapy

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2500105755

Enrollment

Unknown

Registered

2025-07-10

Start date

2025-07-20

Completion date

Unknown

Last updated

2025-07-14

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

Conditions

Advanced gastric cancer

Interventions

Test Group:On the day of the first cycle of immunotherapy medication, a combination of Lactobacillus and Bifidobacterium preparations (Lishi Active Lactic Acid Bacteria Powder, 8x1010CFU) were orally

Control Group:Routine Care

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients with a confirmed pathological histology and/or cytology diagnosis of gastric malignancy; 2. Patients with advanced or locally advanced cancer who are not candidates for surgical treatment; 3. Patients expected to receive anti-PD-1 monoclonal antibody immunotherapy within 2 weeks; 4. Aged >=18 years and <=75 years; 5. No restrictions on gender; 6. Patients capable of independent oral intake; 7. Expected survival time of =3 months; 8. Conscious and able to respond independently to questions; 9. Demonstrates good compliance, voluntarily agrees to participate, and signs the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients undergoing concurrent radiotherapy; 2. Patients with severe mental illness; 3. Patients who are unable to eat or drink (e.g., those with complete intestinal obstruction or active gastrointestinal bleeding); 4. Patients with a history of or concurrent irritable bowel syndrome, malabsorption syndrome, inflammatory bowel disease, or ileostomy; 5. Patients with liver or kidney dysfunction (ALT =2 times the upper limit of normal, total bilirubin =2 times the upper limit of normal, or creatinine =2 times the upper limit of normal); 6. Patients with a history of allergy to any component of the study product; 7. Patients who have taken probiotics, prebiotics, or synbiotics within the past 3 months; 8. Patients who have used antibiotics within the past 2 weeks; 9. Patients who have participated in another nutrition-related interventional clinical study within the past 4 weeks; 10. Pregnant or breastfeeding women; 11. Cases deemed unsuitable for enrollment by the investigator.

Design outcomes

Secondary

Measure	Time frame
Weight;Gastrointestinal adverse effects;Ablumin;	—

Primary

Measure	Time frame
Objective Response Rate (ORR);	—

Countries

China

Contacts

Public ContactShuqing Wei

Shanxi Provincel Cancer Hospital

weishuqing1972@163.com+86 351 4651307

Outcome results

None listed

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