PBCLN-014 + PBCLN-010 for Blood Cancer

Recruiting in Palo Alto (17 mi)

+1 other location

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Prolacta Bioscience

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing a combination of special sugars (HMO) and beneficial bacteria (B. infantis) to help improve gut health in patients who have received a type of stem cell transplant. These patients often have problems with harmful bacteria in their gut. The treatment aims to feed good bacteria so they can grow and reduce the harmful ones.

Research Team

Eligibility Criteria

Adults aged 18-75 planning to receive their first allogeneic hematopoietic cell transplantation (allo-HCT) for blood cancers can join. They must be able to follow the study plan and have signed a consent form. People with prior bowel resections leading to colostomy, serious illnesses affecting study participation, or women who are pregnant or breastfeeding cannot participate.

Inclusion Criteria

I am planning to have my first bone marrow transplant from a donor.

Able to comply with protocol requirements

Signed informed consent prior to initiation of any study-specific procedure or treatment

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Exclusion Criteria

Serious medical or psychiatric illness likely to interfere with participation in study

History or presence, upon clinical evaluation, of any illness that, in the opinion of the Investigator, would interfere with the ability to provide informed consent or comply with study instructions

I am not pregnant, breastfeeding, or planning to become pregnant during the study.

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Treatment Details

Interventions

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

Trial OverviewThe trial is testing the effects of two substances on gut health in allo-HCT recipients: HMO (PBCLN-010) and B. infantis (PBCLN-014). Participants will be divided into three groups; two will receive different doses of HMO along with B. infantis twice daily, while a control group won't get these substances.

Participant Groups

3Treatment groups

Experimental Treatment

Active Control

Group I: Cohort B: HMO 4.5 g and B. infantisExperimental Treatment1 Intervention

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

Group II: Cohort A: HMO 9.0 g and B. infantisExperimental Treatment1 Intervention

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).

Group III: Cohort CActive Control1 Intervention

Participants in this cohort will not receive any study drug