Recruiting
Phase 2

Enteral Nutrition

Sponsor:

University of Nebraska

Code:

NCT07315165

Conditions

Allogeneic Hematopoietic Stem Cell Transplant (Allo-HSCT)

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

Enteral Nutrition

Study Details

Brief summary:

This is a randomized controlled phase II trial which will enroll 112 patients with a diagnosis of a blood cancer or a serious blood disorder who plan to undergo an allogenic hematopoietic stem cell transplant using any conditioning regimen or graft source. Eligible patients will be randomized to receive standard of care (e.g., initiation of supplemental nutrition when oral intake declines) versus enteral nutrition via enteral feeding tube starting on day +1 post-transplant for at least 7 days, usually until engraftment.

Conditions

Allogeneic Hematopoietic Stem Cell Transplant (Allo-HSCT)

Study ID

NCT07315165

Start date

Jul 22, 2026

Status verified date

Dec, 2025

Completion date

May, 2031

Anticipated

Primary completion date

Oct, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

112 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: The control (initiation of supplemental enteral or parenteral nutrition as clinically indicated)

Subjects randomized to the control group with preserved oral intake will initiate conventional oral nutrition as tolerated. The dietary regimen is composed of a balanced general diet. Early supplemental nutrition will not be initiated in patients with the control group who are maintaining adequate oral intake.

experimental: The study group (enteral nutrition starting on day +1)

The study group will start blenderized nutrition formula supplementation via enteral feeding tube on day +1 after transplant.

Interventions

Enteral Nutrition

A commercially available blenderized tube feed nutrition (BTF) formula will be initiated at a fixed starting rate of 25 ml/hr. The infusion rate will be increased in consultation with a registered dietitian nutritionist (RDN) based on tolerance to reach a feeding goal of 30-35 kcal/kg/day, which includes 1.5-2 g of protein/kg/day.

Primary outcome measure

  • Incidence of Stage 3-4 Acute GVHD of Lower Gut [ Time Frame: 100 Days post- transplant ]

Central Contacts and Locations

Central contacts

Krishna vamsi Gottipati, MS

(402) 5593518krgottipati@unmc.edu

IIT Office Clinical Trails Office

(402) 5590963IITOFFICE@unmc.edu

Locations

Fred & Pamela Buffet Cancer Center

Recruiting

Omaha, Nebraska, United States, 68198

Contacts

Michael Haddadin, MD

(402) 5593848mihaddadin@unmc.edu

More Information

Sponsor

University of Nebraska

Last update posted

Aug 31, 2026

Last verified

Dec, 2025

Keywords

  • Enteral Nutrition
  • Acute GVHD
  • Stage 3-4, Stage 2-4 Gut GVHD
  • Nutritional Support
  • allo-HSCT

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Nebraska on 2026-08-31.