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Study on intestinal microenvironment and immune function of patients with pelvic tumor radiotherapy and chemotherapy by Bifidobacterium lactis M8

Study on intestinal microenvironment and immune function of patients with pelvic tumor radiotherapy and chemotherapy by Bifidobacterium lactis M8

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800017217
Enrollment
Unknown
Registered
2018-07-18
Start date
2018-08-01
Completion date
Unknown
Last updated
2018-07-23

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

Conditions

pelvic tumor

Interventions

treatment group:Bifidobacterium lactis M8
Control group:None

Sponsors

Weihai Municipal Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. The patient is fully informed and voluntarily signed a written informed consent form prior to the start of any research-related procedures; 2. Age 18-75 years old; 3. Patients diagnosed with cervical cancer by pathology; 4. The patient is in good general condition with a KPS > 70 points; 5. Life expectancy is at least 6 months. 6. The function of each organ is basically normal (in the absence of continuous supportive treatment, the results of laboratory tests within one week prior to enrollment): neutrophils > 1.5 × 109 / L, platelets > 100 × 109 / L, hemoglobin > 9.0g/dl, normal bilirubin or <1.5×ULN, ALT, AST<2.5×ULN, serum creatinine 1.5×ULN, normal stool.

Exclusion criteria

Exclusion criteria: 1. The general condition is poor, KPS <70 points; 2. Pregnant women, lactating women; 3. a second primary tumor; 4. suffering from chronic digestive diseases, such as peptic ulcer, inflammatory bowel disease, severe liver disease and other patients; 5. Long-term use of immunosuppressive agents or antibiotics within 1 month prior to enrollment; 6. Accept other clinical trial patients at the same time; 7. Allergic to the test sample or obvious gastrointestinal symptoms such as intolerance; 8. Patients diagnosed with HIV/AIDS or liver disease; 9. Patients who depend on controlled drugs or/and alcohol; 10. Patients undergoing anticoagulant therapy; 11. Patients who refuse to sign an informed consent form; 12. Patients taking antibiotics during follow-up (without the consent or guidance of the competent physician); 13. Patients with irregular eating habits and large changes during follow-up.

Design outcomes

Primary

MeasureTime frame
D-lactic acid;Plasma diamine oxidase;Plasma endotoxin;Humoral immune function test;Blood routine;Macrophages;Stool routine;

Countries

China

Contacts

Public ContactYang Fujun

Weihai Municipal Hospital

yangfujun228@163.com+86 18660377195

Outcome results

None listed

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