The High Fiber Program to Increase Fiber Intake Among Patients Undergoing Allogeneic Hematopoietic Cell Transplant

Starting soon · Not applicable

Conditions studied: Hematopoietic and Lymphatic System Neoplasm

In brief

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.

Key facts

Study ID

NCT07664670

Run by

City of Hope Medical Center

People needed

44

Starts

2027-02-13

Expected to finish

2028-06-03

Last updated by the study team

2026-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 6 months post-HCT
• Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for > 1 year (women only)

You may not qualify if…

• PRE-SCREENING EXCLUSION: Clinically significant uncontrolled illness
• PRE-SCREENING EXCLUSION: Active infection requiring antibiotics
• PRE-SCREENING EXCLUSION: History of chronic gastrointestinal conditions such as inflammatory bowel disease or Crohn's disease
• PRE-SCREENING EXCLUSION: Medical contraindications to incorporating fiber in their diet as determined by the treating physician
• PRE-SCREENING EXCLUSION: Self-reported major dietary restrictions limiting fiber intake
• PRE-SCREENING EXCLUSION: Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
• PRE-SCREENING EXCLUSION: Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
• MAIN EXCLUSION: Clinically significant uncontrolled illness
• MAIN EXCLUSION: Active infection requiring antibiotics
• MAIN EXCLUSION: History of chronic gastrointestinal conditions such as inflammatory bowel disease or Crohn's disease
• MAIN EXCLUSION: Medical contraindications to incorporating fiber in their diet as determined by the treating physician
• MAIN EXCLUSION: Self-reported major dietary restrictions limiting fiber intake
• MAIN EXCLUSION: Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
• MAIN EXCLUSION: Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

Where it is running

• City of Hope Medical Center — Duarte, California, United States

Full record on ClinicalTrials.gov

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