Oral Supplementation of 2'-Fucosyllactose in Allogeneic Bone Marrow Transplant Recipients (NCT04263597) | Clinical Trial Compass
CompletedPhase 1/2
Oral Supplementation of 2'-Fucosyllactose in Allogeneic Bone Marrow Transplant Recipients
United States70 participantsStarted 2020-08-26
Plain-language 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.
Phase II:
The investigators hypothesize that 2FL supplementation will be safe and tolerable and result in an increase in the relative abundance of fecal short chain fatty acids such as butyrate, acetate and propionate at day+7 compared to baseline values.
Who can participate
Age range
0 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of bloodstream infections
Timeframe: Day+100 after transplant
2
Number of patients able to take 2FL
Timeframe: 1 week prior to start of chemotherapy until day+30 after transplant
3
Change in fecal butyrate/acetate/propionate levels
Timeframe: Day+ 7 after transplant
Trial details
NCT IDNCT04263597
SponsorChildren's Hospital Medical Center, Cincinnati