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Sustained Oral Fiber Supplementation for Patients Undergoing Donor Stem Cell Transplantation for Hematological Malignancies

NCT04829136 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-05-06

No results posted yet for this study

Summary

This clinical trial examines sustained oral fiber supplementation for patients undergoing donor stem cell transplantation for hematological malignancies. Patients undergoing donor stem cell transplantation often develop oral and gastrointestinal damage from chemotherapy, radiotherapy, or graft-versus-host disease. Oral fiber nutrition support may improve overall nutrition, support a normal gut microbiome (bacteria that live in the gut) and/or improve gut function in patients undergoing stem cell transplants.

Conditions

  • Hematopoietic and Lymphatic System Neoplasm

Interventions

DIETARY_SUPPLEMENT

Kate Farms 1.0

Given enteral nutrition via nasoenteric feeding

DIETARY_SUPPLEMENT

Standard of Care Nutritional Support

Given standard of care, which may be parenteral nutrition

OTHER

Survey Administration

Ancillary studies

DIETARY_SUPPLEMENT

Dietary Supplement

Receive fiber supplementation orally or enterally

PROCEDURE

Biospecimen Collection

Undergo collection of blood and stool samples

OTHER

Electronic Health Record Review

Ancillary studies

OTHER

Fiber and Dietary Assessments

Ancillary studies

Sponsors & Collaborators

  • Fred Hutchinson Cancer Center

    lead OTHER

Principal Investigators

  • David Fredricks · Fred Hutch/University of Washington Cancer Consortium

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-22
Primary Completion
2027-07-31
Completion
2027-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04829136 on ClinicalTrials.gov