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The purpose of this study is to see whether hematopoietic stem cell transplant (HSCT) patients can consistently eat a diet rich in prebiotics. This type of diet may be helpful in maintaining diversity in the gastrointestinal (GI) system and therefore potentially decreasing risk of other GI problems.
Maintaining gastrointestinal (GI) microbiome diversity has been shown to improve treatment related mortality in HSCT patients. Interventions to improve GI microbial diversity could be beneficial to this patient population. Diets rich in prebiotics have been shown to increase gut microbial diversity and improve symptoms in other gastrointestinal diseases. Prebiotics are non-digestible carbohydrates that promote growth of commensal organisms in the gut by providing nutrition. Some examples are brown rice, green apples, and tomatoes. Our theory is that consuming a diet rich in prebiotics pre- and during the first 100 days following HSCT will help to reduce acute graft versus host disease (aGVHD) overall, and specifically acute GI GVHD, and clostridium difficile (C.Diff). Participants will be encouraged to eat at least 2 servings of a prebiotic-rich food from time of admission for HSCT through 100 days following HSCT and will be clinically monitored, including for acute GVHD, acute GI GVHD and C.Diff. Stool samples will be collected from all participants about once every 4 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prebiotic diet | Experimental | 2 servings a day of pre-biotics every day from start of conditioning regimen for HSCT through 100 days following HSCT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pre-biotic foods/drinks | Other | 2 servings per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of participants ingesting the required diet | Frequency of participants reporting ingesting at least 2 servings of prebiotics on ≥ 80% of study days | From initiation of conditioning regimen for HSCT through 100 days following HSCT |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of acute GVHD (aGVHD) and acute GI GVHD | Stage and grade of aGVHD (allogeneic HSCT participants only) | Within the first 100 days following HSCT |
| Incidence of CDiff infection |
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Inclusion Criteria:
Agreement to adhere to Lifestyle Considerations(prebiotic diet) throughout study duration
Adults (≥18 yrs of age)
Able to provide informed consent
Are willing/able to incorporate the required foods in their diet
Eligible, suitable and planning to undergo a stem cell transplant:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Indumathy Varadarajan | Assistant Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia | Charlottesville | Virginia | 22903 | United States |
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Number of people diagnosed with CDiff during the time frame
| Within the first 100 days following HSCT |
| Patient weight | From initiation of conditioning regimen for HSCT through 100 days following HSCT |
| Number of days to neutrophil engraftment | Absolute neutrophil count >1000 for 1 day or > 500 for 3 consecutive days | From initiation of conditioning regimen for HSCT through 100 days following HSCT |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D015470 | Leukemia, Myeloid, Acute |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D008228 | Lymphoma, Non-Hodgkin |
| D006689 | Hodgkin Disease |
| D055728 | Primary Myelofibrosis |
| D009190 | Myelodysplastic Syndromes |
| D009196 | Myeloproliferative Disorders |
| D000755 | Anemia, Sickle Cell |
| D020522 | Lymphoma, Mantle-Cell |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D007945 | Leukemia, Lymphoid |
| D008206 | Lymphatic Diseases |
| D008223 | Lymphoma |
| D001855 | Bone Marrow Diseases |
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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