Effect of adding sodium butyrate to BCG on bodys immune system and urinary bladder microorganisms in patients with urinary bladder cancer
Phase 2
- Conditions
- Health Condition 1: O- Medical and Surgical
- Registration Number
- CTRI/2022/02/040207
- Lead Sponsor
- AIIMS Bhubaneswar
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Diagnosed cases of NMIBC who are candidates for Adjuvant Intravesical BCG therapy.
Exclusion Criteria
Patients not consenting to participate in the trial.
Patients with active UTI.
Patients Muscle invasive bladder cancer
Patients with incomplete resection on the previous TURBT.
Patients who received antibiotics in the past one month.
Patients with prior pelvic Radiotherapy for any cause.
Patients of T1G3/T1High-Grade being considered for â??earlyâ?? Radical cystectomy.
Patients with non-urothelial (TCC) bladder cancer undergoing Radical Cystectomy.
Patient performance status ECOG greater than 2.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the meta-transcriptome in patients receiving intravesical sodium butyrate and intravesical BCG versus patients receiving intravesical BCG alone.Timepoint: 3 months following BCG induction therapy
- Secondary Outcome Measures
Name Time Method To compare the microbiome in patients receiving intravesical sodium butyrate and intravesical BCG versus patients receiving intravesical BCG alone.Timepoint: 3 months following BCG induction therapy;To compare the tumour immune-microenvironment in patients receiving intravesical sodium butyrate and intravesical BCG versus patients receiving intravesical BCG aloneTimepoint: 3 months following BCG induction therapy