Effect of adding sodium butyrate to BCG on bodys immune system and urinary bladder microorganisms in patients with urinary bladder cancer

Supplementary Intravesical Sodium Butyrate to Intravesical Bacillus Calmette-GuÃ©rin in Non Muscle Invasive Bladder Cancer: A Study on the Tumour Immuno-microenvironment and A Meta-transcriptomic and Microbiome analysis.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/02/040207

Enrollment

Registered

2022-02-10

Start date

Unknown

Completion date

Unknown

Last updated

2022-02-21

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: intravesical sodium butyrate and intravesical BCG.: patients in the treatment arm will receive sodium butyrate intravesical 2 hrs. before BCG instillation during induction therapy Contr

Eligibility

Inclusion criteria

Inclusion criteria: Diagnosed cases of NMIBC who are candidates for Adjuvant Intravesical BCG therapy.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

India

Contacts

Public ContactDr Prasant Nayak

AIIMS, Bhubaneswar

urol_prasant@aiimsbhubaneswar.edu.in

Outcome results

None listed

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