Acute Lymphoblastic Leukemia, Acute Lymphocytic Leukemia, Acute Myeloid Leukemia, Hodgkin Disease, Hodgkin Lymphoma, Mantle Cell Lymphoma, Multiple Myeloma, Myelodysplastic Syndromes, Myelofibrosis, Myeloproliferative Neoplasm, Non Hodgkin Lymphoma, Sickle Cell Disease
Conditions
Keywords
hematopoietic stem cell transplant, stem cell transplant, bone marrow transplant, GI microbiome
Brief summary
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.
Detailed description
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.
Interventions
OTHERPre-biotic foods/drinks
2 servings per day
Sponsors
University of Virginia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Agreement to adhere to Lifestyle Considerations(prebiotic diet) throughout study duration 2. Adults (≥18 yrs of age) 3. Able to provide informed consent 4. Are willing/able to incorporate the required foods in their diet 5. Eligible, suitable and planning to undergo a stem cell transplant: 1. Either allogeneic or autologous 2. With any conditioning regimen (e.g. both myeloablative and reduced intensity conditioning) 3. Matched related, matched unrelated, haplo-identical and cord blood transplants will be included.
Exclusion criteria
1. Patients undergoing a second allogeneic or autologous transplant or an allogeneic transplant after an autologous transplant. 2. Anticipation of requirement of broad spectrum antibiotics 1 week prior to admission for HSCT (through HSCT) 3. Patients with any prior history of C.Diff infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of participants ingesting the required diet | From initiation of conditioning regimen for HSCT through 100 days following HSCT | Frequency of participants reporting ingesting at least 2 servings of prebiotics on ≥ 80% of study days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of acute GVHD (aGVHD) and acute GI GVHD | Within the first 100 days following HSCT | Stage and grade of aGVHD (allogeneic HSCT participants only) |
| Incidence of CDiff infection | Within the first 100 days following HSCT | Number of people diagnosed with CDiff during the time frame |
| Patient weight | From initiation of conditioning regimen for HSCT through 100 days following HSCT | — |
| Number of days to neutrophil engraftment | From initiation of conditioning regimen for HSCT through 100 days following HSCT | Absolute neutrophil count \>1000 for 1 day or \> 500 for 3 consecutive days |
Countries
United States
Outcome results
None listed