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Official title Safety, Tolerability, and Efficacy of Enteral Nutrition Versus Standard of Care Nutrition in Hematopoietic Stem Cell Transplant Patients: A Pilot Study
ClinicalTrials.gov ID: NCT06004063
What this study is testing
- What it's testing
- The goal of this research study is to learn if feeding someone after a stem cell transplant is safe and practical.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Have plans to be admitted or be admitted to an inpatient pediatric or adult ward for the purpose of HSCT.
- Be greater than 2 years of age and less than 25 years of age at time of study enrollment.
- Participants \> 18 or guardians for participants \ 7 years old. a) Participants must be English, Italian, Chinese/Mandarin, or Spanish speaking
- Participants will be encouraged to co-enroll on two additional related energy -balance protocols (highly encouraged but not required)
- MDACC protocol PA18-0130. This protocol will enable us to track physical activity through their receipt of a Fitbit (Pediatric Energy Balance Data...
You likely can't join if
- Patients in whom EN is contraindicated (e.g intestinal ischemia, complete bowel obstruction, or other anatomical obstructive process), or all...
- Females who are pregnant. We follow FACT guidelines. Per Foundation for the Accreditation of Cellular Therapy (FACT), female patients must have a...
See the full eligibility criteria
- Have plans to be admitted or be admitted to an inpatient pediatric or adult ward for the purpose of HSCT.
- Be greater than 2 years of age and less than 25 years of age at time of study enrollment.
- Participants \> 18 or guardians for participants \ 7 years old. a) Participants must be English, Italian, Chinese/Mandarin, or Spanish speaking
- Participants will be encouraged to co-enroll on two additional related energy -balance protocols (highly encouraged but not required)
- MDACC protocol PA18-0130. This protocol will enable us to track physical activity through their receipt of a Fitbit (Pediatric Energy Balance Data Repository Protocol.) , and
- MDACC protocol LAB99-062 "A Study to Collect Peripheral Blood, Tissue, and Bone Marrow samples from Donors and Recipients of blood and marrow transplants for Laboratory Research" which will allow collection of stool for...
- Participants will be asked to consider co-enrollment on Stem Cell Registry study (not required):
- PA19-0756: This is a prospective multi-center study to understand the contribution of vascular endothelial dysfunction towards morbidity and mortality among children and adolescents/young adults (AYA) undergoing HCT/CT.
- Patients in whom EN is contraindicated (e.g intestinal ischemia, complete bowel obstruction, or other anatomical obstructive process), or all available routes of EN are contraindicated. Surgical GT placements for the...
- Females who are pregnant. We follow FACT guidelines. Per Foundation for the Accreditation of Cellular Therapy (FACT), female patients must have a negative pregnancy test 7 days prior to bone marrow transplant.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.