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HMO will be administered at 9.0 g orally twice a day (BID), and B. infantis will be administered orally twice a day (BID) (total of 43 days of dosing).

HMO will be administered at 4.5 g orally BID, and B. infantis will be administered orally BID (total of 43 days of dosing).

Participants in this cohort will not receive any study drug

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

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

Greg McKenzie, PhD

Carol Lewis-Cullinan, MSN, FNP-BC

Brittne Acremont, BSN, RN

Amin Alousi, MD

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.

3 cohorts: Cohort A and B receive combination study drug in difference doses (Cohort A receives HMO 9.0 g and B. infantis; Cohort B received HMO 4.5 g and B. infantis) Cohort C does not receive study drug

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

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 title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study To Evaluate The Safety And Efficacy of PBCLN-010 In Combination With PBCLN-014 in Participants Receiving Allogeneic Hematopoietic Cell Transplantation	NCT06102213	Hematologic Mal...	B. infantis (PB...	18 Years - 75 Years	Prolacta Bioscience
Study To Evaluate The Safety And Efficacy of PBCLN-010 In Combination With PBCLN-014 in Participants Receiving Allogeneic Hematopoietic Cell Transplantation	NCT06102213	Hematologic Mal...	B. infantis (PB...	18 Years - 75 Years	Prolacta Bioscience

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