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Sustained Oral Fiber Supplementation for Patients Undergoing Donor Stem Cell Transplantation for Hematological Malignancies
Study Purpose
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.
Recruitment Criteria
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
Inclusion Criteria:
Exclusion Criteria:
- - Pregnant or breastfeeding.
Pregnancy test is obtained as part of pre-transplant evaluation in women of child-bearing potential at arrival to transplant and again within 7 days of conditioning and will be confirmed as negative by review of the chartTrial Details
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
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The person who is responsible for the scientific and technical direction of the entire clinical study.
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
OUTLINE: Current study design: Patients receive fiber supplementation orally (PO) or enterally starting 14 days prior to day 1 of conditioning chemotherapy and continuing until discharge Patients who are not able to receive sufficient nutrition by mouth may receive parenteral nutrition or enteral nutrition by feeding tube from the hospital. Patients may undergo blood sample collection throughout the study. Previous study design: Before this study was amended in January 2024, patients were randomized to 1 of 2 arms. Previous Arm I: Patients received enteral nutrition via nasoenteric feeding tube starting on day 1 until hospital discharge. Previous Arm II: Patients received standard of care nutritional support.
Arms
Experimental: Arm I (enteral nutrition) [Discontinued in January 2024]
Patients receive enteral nutrition via nasoenteric feeding tube starting on day 1 until hospital discharge.
Active Comparator: Arm II (standard of care) [Discontinued in January 2024]
Patients receive standard of care nutritional support.
Experimental: Supportive care (Fiber) [Current study activity]
Patients receive fiber supplementation PO or enterally starting 14 days prior to day 1 of conditioning chemotherapy and continuing until discharge from the hospital. Stool will be collected at different time points throughout the study. Patients may also undergo blood sample collection throughout the study.
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
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Recruiting
Address
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
Site Contact
David Fredricks
[email protected]
206-667-1935
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