Oral Supplementation of 2'-Fucosyllactose in Allogeneic Bone Marrow Transplant Recipients

  • STATUS
    Recruiting
  • End date
    Sep 13, 2025
  • participants needed
    70
  • sponsor
    Children's Hospital Medical Center, Cincinnati
Updated on 13 June 2022
graft versus host disease
bone marrow transplant
acute graft-versus-host disease
allogeneic hematopoietic stem cell transplant

Summary

High dose chemotherapy and radiation used as preparative regimens in patients undergoing an allogeneic hematopoietic stem cell transplant (HSCT) disrupts intestinal homeostasis by damaging the intestinal epithelium and altering the intestinal microbiome. The investigators hypothesize that 2'-fucosyllactose (2FL) supplementation will be safe and tolerable and result in an increase in the relative abundance of intestinal Bifidobacteria. The investigators also hypothesize that 2FL supplementation will lead to reduction of Firmicutes and/or Proteobacteria, and improved intestinal homeostasis at day+30 as measured by lower pro-inflammatory cytokines, reduced levels of T-cell activation, lower markers of intestinal injury (fecal human DNA and plasma reg-3-alpha), increased fecal butyrate levels and ultimately lower incidence of acute GVHD and BSI at day+100.

Description

This phase I/IIa study is a single center prospective study at Cincinnati Children's Hospital Medical Center (CCHMC).

This study will assess the safety and tolerability of various doses of 2FL. Eligible patients will be allocated to the following arms as determined by age at enrollment:

Arm 1: 0-5 years; Arm 2: 5.1-10 years; Arm 3: >10 years

The investigators will first enroll 5 patients of ages ≥10 years undergoing allogeneic HSCT. 2'-FL will be administered to these patients from day-7 until day+30 after HSCT at the starting dose for the ≥10 years age group. Once safety is determined the investigators will then enroll an additional 5 patients of ages 5-10 years and 5 patients of ages 0-5 years and administer 2'FL at starting doses according to their age group to children from day-7 to day+30 after HSCT. Enrollment in the 2 defined age groups (5-10 years and 0-5 years) will occur independent of each other/in parallel to establish safety. Once safety is established in these patients the investigators will proceed with the 3x3 study design dose finding portion of our study

Three patients will be enrolled in each arm at the starting dose level. Investigators will perform a dose escalation or de-escalation based on rates of dose limiting toxicities.

Details
Condition Hematopoietic Stem Cell Transplant
Treatment 2'-fucosyllactose, Placebo (2g oral glucose)
Clinical Study IdentifierNCT04263597
SponsorChildren's Hospital Medical Center, Cincinnati
Last Modified on13 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Be scheduled for allogeneic stem cell transplant
All ages and underlying diagnoses, preparative regimens, stem cell sources and acute GVHD prophylaxes

Exclusion Criteria

Unable to take anything orally or enterally (i.e. intestinal failure)
Actively breastfeeding infants
Recent (within the week prior to enrollment) GI infection
Patients receiving anti-diarrheal medications such as loperamide
Patients who have received probiotics or prebiotics during the previous month
Patients who have had any type of gut damage within the past 3 months such as previous bowel perforations, previous episode of Grade 4 neutropenic colitis or typhlitis
Patients with inflammatory bowel disease, short bowel syndrome, and patients with a history of bowel resections
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