Spots Global Cancer Trial Database for Study To Evaluate The Safety And Efficacy of PBCLN-010 In Combination With PBCLN-014 in Participants Receiving Allogeneic Hematopoietic Cell Transplantation

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Trial Identification

Brief Title: Study To Evaluate The Safety And Efficacy of PBCLN-010 In Combination With PBCLN-014 in Participants Receiving Allogeneic Hematopoietic Cell Transplantation

Official Title: A Randomized, Open-Label, Multicenter, Phase 2a Study To Evaluate The Safety And Efficacy of PBCLN-010 In Combination With PBCLN-014 in Participants Receiving Allogeneic Hematopoietic Cell Transplantation (Allo-HCT)

Study ID: NCT06102213

Conditions

Hematologic Malignancy

Interventions

B. infantis (PBCLN-014) and Human Milk Oligosaccharides (HMO) (PBCLN-010)

Study Description

Brief Summary: This is a Phase 2a, open-label, multicenter study to evaluate the safety and efficacy of HMO (PBCLN-010) and B. infantis (PBCLN-014) on the gut microbiome and GI domination by pathobionts in participants receiving allo-HCT. Approximately 60 participants will be enrolled in this study, and all participants will undergo screening assessments up to 28 days before the first study drug dose (D 7). Participants meeting all the eligibility criteria based on the screening assessments will be enrolled and randomly assigned to 1 of the 3 cohorts: * Cohort A (HMO 9.0 g and B. infantis) BID * Cohort B (HMO 4.5 g and B. infantis) BID * Cohort C (Control Cohort): Participants in this cohort will not receive any study drug.

Detailed Description: