Clinical trial NCT04629430: Effects of Prebiotics on Gut Microbiome in Patients Undergoing HSCT
Official title: Effects of Prebiotics on Gut Microbiome in Patients Undergoing Stem Cell Transplants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Myeloma
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Non Hodgkin Lymphoma
Acute Lymphocytic Leukemia
Hodgkin Lymphoma
Hodgkin Disease
Myelofibrosis
Myelodysplastic Syndromes
Myeloproliferative Neoplasm
Sickle Cell Disease
Mantle Cell Lymphoma
Keywords: hematopoietic stem cell transplant
stem cell transplant
bone marrow transplant
GI microbiome
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2020-11-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Frequency of participants ingesting the required diet
timeFrame: From initiation of conditioning regimen for HSCT through 100 days following HSCT
Secondary outcomes:
measure: Incidence and severity of acute GVHD (aGVHD) and acute GI GVHD
timeFrame: Within the first 100 days following HSCT
measure: Incidence of CDiff infection
timeFrame: Within the first 100 days following HSCT
measure: Patient weight
timeFrame: From initiation of conditioning regimen for HSCT through 100 days following HSCT
measure: Number of days to neutrophil engraftment
timeFrame: From initiation of conditioning regimen for HSCT through 100 days following HSCT
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: Assistant Professor
name: Indumathy Varadarajan
role: PRINCIPAL_INVESTIGATOR
References: