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Probiotics for patients with cancers

A Phase 2b study to determine the efficacy of probiotics given in peritransplant period among allogenic stem cell transplant recipients in preventing gram negative bacteremia, mortality, graft versus host disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/03/032021
Enrollment
100
Registered
2021-03-16
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: D759- Disease of blood and blood-formingorgans, unspecified

Interventions

Intervention1: oral Capsule Lobun (Probiotics): 15 billion unit once daily x 180days Control Intervention1: Standard of care: IV Fluids, Antibiotics, Vasopressors

Sponsors

Christian Medical College Vellore
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Age >18 years. 2) Undergoing Allogenic Stem cell transplant in the Department of Haematology, CMC Vellore. 3) Presence of CRO or ESBL organism in Pre-transplant Fecal surveillance

Exclusion criteria

Exclusion criteria: 1) Age 2) Susceptible organisms in the Pre-transplant Faecal surveillance. 3) Patients who already have an ongoing bacterial infection at the time of HSCT.

Design outcomes

Primary

MeasureTime frame
Incidence of Gram negative bacteraemia and culture negative sepsis, for a period of 180 days after HSCT.Timepoint: 180 days—

Secondary

MeasureTime frame
1) Incidence of bacteraemia (gram positive and gram negative). 2) All-cause mortality at days- 30, 60, 90- and 180-days post HSCT. 3) Incidence of graft versus host disease. 4) Incidence of Clostridium difficile infection (CDI). 5) Incidence of lactobacillus bacteraemiaTimepoint: 30, 60, 90- and 180-days—

Countries

India

Contacts

Public ContactSelwyn Selva Kumar D

Christian Medical College, Vellore

selwyndssk@gmail.com9789249787

Outcome results

None listed

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