Effects of Prebiotics on Gut Microbiome in Patients Undergoing HSCT (HCTDiet)

University of Virginia

Status: Completed

Conditions: Myelofibrosis; Hodgkin Lymphoma; Mantle Cell Lymphoma; Sickle Cell Disease; Non Hodgkin Lymphoma; Myelodysplastic Syndromes; Acute Lymphocytic Leukemia; Multiple Myeloma; Myeloproliferative Neoplasm; Hodgkin Disease; Acute Lymphoblastic Leukemia; Acute Myeloid Leukemia

Treatments: Other: Pre-biotic foods/drinks

Study type: Interventional

Funder types: Other

Identifiers

NCT04629430

HSR 200296

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Prebiotic diet

Experimental group

Description:

2 servings a day of pre-biotics every day from start of conditioning regimen for HSCT through 100 days following HSCT

Treatment:

Other: Pre-biotic foods/drinks