Enteral nutrition in people receiving allogeneic stem cell transplant
Official title: A Phase II Randomized Trial of Enteral Nutrition Versus Standard of Care in Allogeneic Hematopoietic Stem Cell Transplantation
Run by University of Nebraska · NCT07315165 · Data updated 2026-11-12
This trial tests whether feeding patients through a tube starting the day after transplant helps people undergoing allogeneic stem cell transplantation compare to the usual care.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 19 Years and up |
| Sex | All |
| Enrollment | 112 (estimated) |
| Sponsor | University of Nebraska Academic / other |
| Locations | 1 site (Omaha, Nebraska) |
| Status | Recruiting |
| Started | July 22, 2026 |
| Main results expected | October 2030 |
| Study ends | May 2031 |
| Registry record updated | August 31, 2026 |
| Trial ID | NCT07315165 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with a hematologic condition planned for allogeneic HSCT, able to undergo enteral feeding if randomized to the intervention.
✕Probably not a fit
Patients unlikely to benefit include those with contraindications to enteral feeding or with conditions where nutrition is not a limiting factor post-transplant.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized phase II trial enrolling 112 patients with blood cancers or related disorders who plan an allogeneic HSCT. Participants are assigned to standard nutrition management or enteral nutrition via a feeding tube starting on day +1 for at least 7 days, typically until engraftment. The primary goal is to see if enteral feeding reduces severe gut-related GVHD (stage 3-4) by day +100, with several secondary outcomes including other GVHD measures, weight and muscle changes, functional status, quality of life, hospital stay, and engraftment timing. Assessments will include GVHD grading, ADL/IADL, Fried Frailty, and FACT-BMT among others.
Why it matters
Potential benefit: If successful, patients may experience lower risk of severe gut GVHD and better overall recovery after transplant.
How similar studies have gone: This approach is based on prior interest in early enteral nutrition; the efficacy in this specific transplant setting is being tested in this trial.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of a hematological condition or serious blood disorder * Patient planned for an allogeneic hematopoietic stem cell transplant * Any conditioning regimen or graft source Exclusion Criteria: * Uncorrected anatomical deformity of the nose, nasopharynx, esophagus, or stomach that could prevent proper placement of a nasogastric tube. * Chronic gastrointestinal conditions causing malabsorption or need for nutritional supplementation, e.g., celiac disease, short gut syndrome, chronic use of total parental nutrition or enteral nutrition for 3 or more months. Uncorrected anatomical deformity may include any known significant deviated nasal septum, large nasal polyps or other masses, or nasal or oropharyngeal trauma.
Where it's running
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Fred & Pamela Buffet Cancer Center
Omaha, Nebraska, United States Recruiting
Study contacts
- Principal investigator: Michael Haddadin, MD — University of Nebraska
- Study coordinator: Krishna vamsi Gottipati, MS
- Email: krgottipati@unmc.edu
- Phone: (402) 5593518
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.