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Lactobacillus Bifidobacterium V9(Kex02)Improving the Efficacy of Carilizumab Combined With Platinum in Non-small Cell Lung Cancer Patients

NCT ID: NCT05094167

Last Updated: 2021-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-19

Study Completion Date

2023-12-30

Brief Summary

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Human microbes have been called "the second genome of humanity".On May 13,2016,the White House launched the National Microbiome Initiative (NMI), with an estimated investment of us $521 million, to elevate microbiome research to a national strategic status. The gut is the largest microecological environment in the human body. The research in the field of intestinal microbiome has become one of the most advanced and hot research directions in the scientific field of the world today. At present, more than 50 diseases have been found to be related to intestinal microbiome disorders. Pd-1 (programmed death receptor 1) is an important immunosuppressive molecule.It regulates the immune system and promotes tolerance by down-regulating the immune system's response to human cells and by suppressing T cell inflammatory activity. In the past, the research team and colleagues in related fields have found a strong correlation between Gut Microbiome and the efficacy of anti-PD-1 immunotherapy in cancer patients.This protects against autoimmune diseases, but it also prevents the immune system from killing cancer cells. As more and more scientific evidence shows that intervention of human intestinal flora may improve the efficacy of anti-PD-1 immunotherapy in tumor patients, intestinal flora, as the most effective way to intervene human intestinal flora, has been mentioned by many research institutions and international drug manufacturers in combination with anti-PD-1.Our previous study showed that the abundance of beneficial bacteria such as lactic acid bacteria, bifidobacteria and Akkermansia Muciniphila was significantly correlated with pD-1 inhibitor response, and regulating the intestinal flora content could improve the effect of PD-1 inhibitor on mouse tumors, indicating that microbial flora was involved in regulating cancer immunotherapy.

Detailed Description

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Conditions

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Non-small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
The random assignment of patients was performed by Nanchang Medical University with a computer-generated random number code. Patients were randomly distributed in a 1:1 ratio to receive probiotics or a placebo (the block size was known only to the statistician). The drug was distributed and packaged in accordance with random numbers, and the documents stating the parameters, such as the blinding codes for the seeds of the random numbers, the block length, and the random numbers, were sealed in envelopes

Study Groups

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probiotics group

The oral probiotic (Lactobacillus Bifidobacterium V9,one times a day during the whole treatment) was isolated from healthy women's breast milk samples in 2017 and was identified as Lactobacillus rhamnosus by physiological and biochemical and 16S rRNA. It is listed as the "List of Probiotics for Health Food" in my country's "List of Bacteria Available for Food", which can be directly applied to food production.

Group Type EXPERIMENTAL

V9

Intervention Type OTHER

one times a day during the whole treatment

placebo group

Immunotherapy with placebo alone

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

placebo

healthy control group

healthy control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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V9

one times a day during the whole treatment

Intervention Type OTHER

placebo

placebo

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Karnofsky score ≥90 in patients receiving immunotherapy for non-small cell lung cancer at our cancer center

Exclusion Criteria

* any immune system disease under high risk to antimicrobial agents such as Diabetes,infection disease or drug allergy to V9
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Inner Mongolia University of Science and Technology

OTHER

Sponsor Role collaborator

Jiangxi Provincial Cancer Hospital

OTHER

Sponsor Role lead

Responsible Party

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Qiang Xu

Chief Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Chunling Jiang

Nanchang, Jiangxi, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Chunling Jiang, doctor

Role: primary

Other Identifiers

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JCL2021-10

Identifier Type: -

Identifier Source: org_study_id