Prebiotic Galacto-oligosaccharide and Acute GVHD

Conditions

• Acute GVHD

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Galacto-oligosaccharide — DIETARY_SUPPLEMENT
  GOS will be administered at determined dose levels per protocol once daily from about 30 days before transplant to about 4 weeks after transplant.
• Maltodextrin — DIETARY_SUPPLEMENT
  Maltodextrin will be administered at comparable dose level as GOS (in Phase II) once daily from about 30 days before transplant to about 4 weeks after transplant.

Study Details

The purpose of this study is to determine whether the carbohydrate prebiotic (dietary supplement) known as galacto-oligosaccharide (GOS) can modulate the microbiome (the bacteria in the gut) and help prevent graft-versus host disease (GVHD) after allogeneic stem cell transplant. The study has two two parts. In phase 1, the best dose of GOS will be evaluated. In phase 2, using the best dose of GOS, participants will be randomized to receive GOS or a placebo (maltodextrin, a common food additive that is not known to affect the microbiome) so that the effect of GOS can be determined.

Key Dates

Start date

Jan 22, 2021

Status verified

Apr 2026

Primary completion

Jun 1, 2027

Completion

Feb 1, 2029

Study Design

Enrollment

128 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: Galacto-oligosaccharide
  Phase I: Subjects will receive GOS, at dose levels 0.75g, 1.5g, and 2.9 g/day administered once daily. GOS will be dosed per the following schedule using a modified 3+3 design: 0.75g x 4 days, followed by 1.5g x 4 days, followed by 2.9g for the duration of the study starting from about 30 days before transplant to about 4 weeks after transplant. Phase II: Subjects will receive GOS, at dose levels 0.25\*MTD, 0.5\*MTD, and MTD with MTD determined by the phase 1 of the study, once daily from about 30 days before transplant to about 4 weeks after transplant.
• Placebo Comparator: Maltodextrin
  Phase II: Subjects will receive maltodextrin at comparable dose level as GOS (in Phase II) once daily from about 30 days before transplant to about 4 weeks after transplant.

Primary Outcome Measure

provisional Maximum Tolerated Dose (pMTD) of GOS [ Time Frame: 30 days ]

Central Contacts

• Beth Turk, MPH, CCRC
  (913) 574-0154
  [email protected]

Locations (2)

Find similar trials in Kansas City, KS