Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 19 and up

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.

More Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) trials

Quick facts

PhasePhase 2
Study typeInterventional
Ages19 Years and up
SexAll
Enrollment112 (estimated)
SponsorUniversity of Nebraska
Academic / other
Locations1 site (Omaha, Nebraska)
StatusRecruiting
StartedJuly 22, 2026
Main results expectedOctober 2030
Study endsMay 2031
Registry record updatedAugust 31, 2026
Trial IDNCT07315165 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

  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.