A Study of Probiotics Administration in the Immunotherapy of Urothelial Bladder Carcinoma

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-05

Study Completion Date

2024-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

A study of the efficacy and safety of probiotics in immunotherapy of urothelial carcinoma.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Probiotics in Advanced Urothelial Carcinoma

NCT06904573

Advanced Urothelial Carcinoma Probiotics Immunotherapy

RECRUITING PHASE2

PD1 Inhibitors Combined With Clostridium Butyricum for Urothelial Carcinoma

NCT06696742

Bladder (Urothelial, Transitional Cell) Cancer

RECRUITING PHASE2

Nutrition Therapy in Improving Immune System in Patients With Bladder Cancer That Can Be Removed by Surgery

NCT03757949

Bladder Carcinoma

ACTIVE_NOT_RECRUITING PHASE3

Catumaxomab in Patients With Non-Muscle-Invasive Bladder Cancer Who Have Failed or Are Intolerant to BCG Vaccine

NCT04799847

Bladder Cancer

UNKNOWN PHASE1/PHASE2

Efficacy and Safety of Pseudomonas Aeruginosa for Intermediate and High-risk Non-muscle Invasive Bladder Cancer

NCT05975151

Bladder Cancer

RECRUITING PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

To evaluate the progression free survival of intestinal probiotics in immunotherapy for urothelial carcinoma. Changes in fecal flora abundance before and after treatment were assessed to identify subjects most likely to benefit from enteric probiotics treatment.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bladder Urothelial Carcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Immunotherapy with Live Combined (Bifidobacterium,Lactobacillus and Enterococcus Capsules)

420mg Live Combined (Bifidobacterium,Lactobacillus and Enterococcus Capsules) bid for 3-4 treatment cycles,21 days per cycle.

Group Type EXPERIMENTAL

Live Combined (Bifidobacterium,Lactobacillus and Enterococcus Capsules)

Intervention Type DRUG

420mg Live Combined (Bifidobacterium,Lactobacillus and Enterococcus Capsules) bid for 4 treatment cycles.

Immunotherapy without Probiotics

control group, Immunotherapy without Probiotics

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Live Combined (Bifidobacterium,Lactobacillus and Enterococcus Capsules)

420mg Live Combined (Bifidobacterium,Lactobacillus and Enterococcus Capsules) bid for 4 treatment cycles.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Probiotic

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Patients diagnosed with urothelial carcinoma and undergoing immunotherapy ;
2. Age ≥ 18 years;
3. Expected survival time is greater than 12 weeks;
4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 1 or 2;
5. Organ function level must meet the following requirements:

Hematological indexes: neutrophil count \>= 1.5x10\^9/L, platelet count \>= 100x10\^9/L, hemoglobin \>= 9.0 g/dl (can be maintained by symptomatic treatment); Liver function: total bilirubin \<=1.5 ULN, alanine aminotransferase and aspartate aminotransferase \<=2.5 ULN (can be maintained by symptomatic treatment);
6. The subjects volunteered to join the study, signed informed consent, and had good compliance with follow-up;
7. Willing and able to provide written informed consent.

Exclusion Criteria

1. Receive live attenuated vaccine within 4 weeks before treatment or during the study period;
2. Active, known or suspected autoimmune diseases;
3. Cannot take orally or are allergic to probiotics ;
4. History of primary immunodeficiency ;
5. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;
6. Pregnant or lactating female patients;
7. Untreated acute or chronic active hepatitis B or hepatitis C infection. Under the condition of monitoring the virus copy number of patients receiving antiviral treatment, doctors can judge whether they are in line with the patients' individual conditions;
8. Uncontrolled concurrent diseases, including but not limited to:

HIV infected (HIV antibody positive); Severe infection in active stage or poorly controlled; Evidence of serious or uncontrollable systemic diseases (such as severe mental, neurological, epilepsy or dementia, unstable or uncompensated respiratory, cardiovascular, liver or kidney diseases, uncontrolled hypertension \[hypertension greater than or equal to conmon terminology criteria for adverse events （CTCAE） grade 2 after drug treatment\]); Patients with active bleeding or new thrombotic disease.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No