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Oligosaccharide

Oral 2'-Fucosyllactose Supplementation for Bone Marrow Transplant Recipients

Phase 1 & 2
Recruiting
Led By Pooja Khandelwal, MD
Research Sponsored by Children's Hospital Medical Center, Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be scheduled for allogeneic stem cell transplant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 week prior to start of chemotherapy until day+30 after transplant
Awards & highlights

Study Summary

This trial is testing whether a sugar supplement called 2'-fucosyllactose (2FL) is safe and improves the gut bacteria in patients undergoing high doses of chemotherapy and radiation as part of their treatment for cancer. The investigators also want to see if 2FL leads to a reduction in inflammation and a lower incidence of complications like gut damage, infection, and acute graft-versus-host disease.

Who is the study for?
This trial is for patients of any age and diagnosis who are scheduled for an allogeneic stem cell transplant. It's not suitable for those unable to take oral supplements, actively breastfeeding infants, anyone with a recent GI infection or taking anti-diarrheal meds, and people who've used probiotics/prebiotics recently or have had significant gut damage in the past 3 months.Check my eligibility
What is being tested?
The trial tests if adding a supplement called 2'-fucosyllactose (2FL) can help balance gut bacteria and reduce inflammation after bone marrow transplants. The goal is to see if it makes the intestines healthier by day+30 post-transplant and lowers complications like acute GVHD and bloodstream infections by day+100.See study design
What are the potential side effects?
While specific side effects aren't listed, since this is a dietary supplement being tested in a vulnerable population, potential side effects could include digestive discomforts such as bloating, gas, nausea or changes in bowel habits.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am scheduled for a stem cell transplant from a donor.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 week prior to start of chemotherapy until day+30 after transplant
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 week prior to start of chemotherapy until day+30 after transplant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of graft versus host disease (GVHD)
Incidence of mucosal barrier injury laboratory-confirmed bloodstream infection (MBI-LCBI)
Number of bloodstream infections
+1 more
Secondary outcome measures
Incidence of acute GVHD
Incidence of bloodstream infections
Increase in fecal butyrate/acetate/propionate levels
+2 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: 2'-fucosyllactose for ages >10 yearsExperimental Treatment1 Intervention
Dose for ages >10 years: 10 g/day;
Group II: 2'-fucosyllactose for ages 5.1-10 yearsExperimental Treatment1 Intervention
Dose for ages 5.1-10 years: 5 g/day;
Group III: 2'-fucosyllactose for ages 0-5 yearsExperimental Treatment1 Intervention
Dose for ages 0-5 years: 2.5 g/day;

Find a Location

Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor
815 Previous Clinical Trials
6,531,526 Total Patients Enrolled
Pooja Khandelwal, MDPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati
4 Previous Clinical Trials
107 Total Patients Enrolled

Media Library

2'-fucosyllactose (Oligosaccharide) Clinical Trial Eligibility Overview. Trial Name: NCT04263597 — Phase 1 & 2
Bone Marrow Transplant Clinical Trial 2023: 2'-fucosyllactose Highlights & Side Effects. Trial Name: NCT04263597 — Phase 1 & 2
2'-fucosyllactose (Oligosaccharide) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04263597 — Phase 1 & 2
Bone Marrow Transplant Research Study Groups: 2'-fucosyllactose for ages >10 years, 2'-fucosyllactose for ages 0-5 years, 2'-fucosyllactose for ages 5.1-10 years
Bone Marrow Transplant Patient Testimony for trial: Trial Name: NCT04263597 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the overarching aim of this experiment?

"The main objective of this clinical trial, which will be monitored at Day+100 after transplantation, is to gauge the number of patients able to take 2FL. Secondary objectives include assessing fecal human DNA in the 2FL group versus placebo control (with a lower level being indicative of success) as well as comparing plasma cytokines and reg 3-alpha levels between both cohorts."

Answered by AI

Is there any availability for participants in this experiment?

"Clinicaltrials.gov confirms that this medical trial is actively seeking participants having initially been posted on August 26th 2020 and tweaked most recently on June 7th 2022."

Answered by AI

How many individuals are currently participating in this clinical research?

"Affirmative. Evidence on clinicaltrials.gov reveal that this experiment, originally posted on August 26th 2020, is currently recruiting patients. Approximately 70 participants need to be assembled from a single research centre."

Answered by AI

Has any research been done on the efficacy of 2'-fucosyllactose?

"Presently, there are two active medical trials involving 2'-fucosyllactose with no Phase 3 studies underway. Of the existing clinical trials for this compound, four different locations have been identified; a majority of these sites are in Cincinnati, Ohio."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

For a friend.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Oral Supplementation of 2'-Fucosyllactose in Allogeneic Bone Marrow Transplant Recipients
2020. "Oral Supplementation of 2'-Fucosyllactose in Allogeneic Bone Marrow Transplant Recipients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04263597.
~20 spots leftby Sep 2025
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