The High Fiber Program to Increase Fiber Intake Among Patients Undergoing Allogeneic Hematopoieti… (NCT07664670) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The High Fiber Program to Increase Fiber Intake Among Patients Undergoing Allogeneic Hematopoietic Cell Transplant
United States44 participantsStarted 2027-02-13
Plain-language summary
This clinical trial studies whether the High Fiber Program can be used to increase fiber intake in patients undergoing allogeneic hematopoietic cell transplant (HCT). Allogeneic HCT is a procedure in which a person receives blood-forming stem cells (cells from which all blood cells develop) from a genetically similar, but not identical, donor. This is often a sister or brother, but could be an unrelated donor. It is a potentially curative therapy for many conditions that affect the blood and blood-forming organs, but many patients must manage post-transplant complications, especially graft versus host disease (GVHD). GVHD occurs when the transplanted cells from a donor attack the body's normal cells causing skin rash or blisters, dry mouth, or dry eyes. The environment and health of the gut is important in allogeneic HCT patients, with an unhealthy gut environment and/or health leading to inflammation and possibly GVHD. Research has shown that diets high in fiber may improve the environment and health of the gut as well as outcomes following transplant; however, fiber intake remains low among patients. The High Fiber Program is a dietitian-led counseling program which teaches patients how to introduce high fiber foods into their diet and identify food choices and personalized strategies that will help them change their diet. The High Fiber Program may be an effective way to increase fiber intake in patients undergoing allogeneic HCT.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* PRE-SCREENING INCLUSION: Documented informed consent of the participant and/or legally authorized representative
* PRE-SCREENING INCLUSION: Age: ≥ 18 years
* PRE-SCREENING INCLUSION: Within healthy body mass index (BMI) range 18-29 at the time of pre-screening consent
* PRE-SCREENING INCLUSION: Ability to read and understand English for questionnaires
* PRE-SCREENING INCLUSION: Patients must be scheduled to receive HCT within the next 30 days after pre-screening consent
* MAIN INCLUSION: Documented informed consent of the participant and/or legally authorized representative
* MAIN INCLUSION: Age: ≥ 18 years
* Patients ≥ 75 years of age that are otherwise eligible to undergo allogeneic HCT are included
* MAIN INCLUSION: Karnofsky performance status ≥ 70%
* MAIN INCLUSION: Within healthy BMI range 18-29 at the time of consent
* MAIN INCLUSION: Ability to read and understand English for questionnaires
* MAIN INCLUSION: Patients receiving myeloablative or reduced intensity conditioning regimens
* MAIN INCLUSION: Adequate organ function consistent with institutional standards for HCT
* MAIN INCLUSION: Patients must be scheduled to receive HCT within 3 weeks of consent
* MAIN INCLUSION: Women of childbearing potential (WOCBP): negative urine or serum pregnancy test (within 45 days prior to the start of conditioning)
* If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
* MAIN INCLUSION: Agreement by …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percent of scheduled dietary counseling sessions attended and withdrawal status (Feasibility)