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Clinical Study on the Prolongation of Survival Period of Probiotics (Bifidobacterium lactis V9) in Patients with Advanced Gastrointestinal Tumors

Clinical Study on the Prolongation of Survival Period of Probiotics (Bifidobacterium lactis V9) in Patients with Stage IV Gastric and Esophageal Cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500104854
Enrollment
Unknown
Registered
2025-06-24
Start date
2024-03-23
Completion date
Unknown
Last updated
2025-06-30

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

Conditions

cancer

Interventions

Test group:Take two bags of Bifidobacterium lactis V9 orally every day
control group:Take a placebo orally, two packs daily

Sponsors

Capital Medical University Affiliated Beijing Shijitan Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Histologically or cytologically confirmed as gastric cancer or esophageal cancer, with stage IV tumor. 2. Age: 18-80 years old; 3. The ECOG physical condition score of the Eastern Oncology Collaboration Group ranged from 0 to 2 points; 4. The expected survival period is more than 4 months; 5. Plan to receive chemotherapy treatment. 6. It can be eaten orally; 7. With my consent and having signed the informed consent form, I am willing and capable of complying with the planned visits, research treatments, laboratory tests and other trial procedures.

Exclusion criteria

Exclusion criteria: 1. Patients with active infections or suffering from mental disorders, cardiovascular and cerebrovascular diseases, severe heart and lung dysfunction, or other patients deemed unsuitable for participation in the study by the researcher; 2. Those who have undergone multiple courses of chemotherapy in the past, extensive radiotherapy, advanced age, bone marrow metastasis, severe infection, adrenal insufficiency, or have severe complications; 3. Pregnant women; 4. Patients who fail to receive treatment on time or fully cooperate. 5. Inability to eat orally, intestinal obstruction, intestinal bleeding, severe short bowel syndrome or high-excretion fistula; 6. Currently participating in other clinical researchers; 7. Patients with severe heart disease, diabetes, hyperlipidemia, electrolyte imbalance, abnormal liver and kidney functions, or other patients deemed unsuitable for participation in the study by the researchers. 8. There is any active autoimmune disease or a history of autoimmune disease with an expected recurrence.

Design outcomes

Primary

MeasureTime frame
One-year survival;

Secondary

MeasureTime frame
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire,EORTC QLQ-C30;Patient-Generated Subjective Global Assessment;Karnofsky Score,KPS ;Tumor Marker;Fecel metagenomics;Fecel metabolomics;

Countries

China

Contacts

Public ContactShi Hanping

Capital Medical University Affiliated Beijing Shijitan Hospital

shihp@ccmu.edu.cn+86 138 0274 1263

Outcome results

None listed

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