Oral Supplementation of 2'-Fucosyllactose in Allogeneic Bone Marrow Transplant Recipients
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- STATUS
- Recruiting
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- End date
- Sep 13, 2025
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- participants needed
- 70
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- sponsor
- Children's Hospital Medical Center, Cincinnati
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 Identifier | NCT04263597 |
| Sponsor | Children's Hospital Medical Center, Cincinnati |
| Last Modified on | 13 June 2022 |
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