Effects of Prebiotics on Gut Microbiome in Patients Undergoing HSCT

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effects of Prebiotics on Gut Microbiome in Patients Undergoing Stem Cell Transplants

Conditions
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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

Intervention / Treatment
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* Other: Pre-biotic foods/drinks


Participation Criteria
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Eligibility Criteria
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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: Either allogeneic or autologous With any conditioning regimen (e.g. both myeloablative and reduced intensity conditioning) Matched related, matched unrelated, haplo-identical and cord blood transplants will be included. Exclusion Criteria: Patients undergoing a second allogeneic or autologous transplant or an allogeneic transplant after an autologous transplant. Anticipation of requirement of broad spectrum antibiotics 1 week prior to admission for HSCT (through HSCT) Patients with any prior history of C.Diff infection

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prebiotic diet<br>2 servings a day of pre-biotics every day from start of conditioning regimen for HSCT through 100 days following HSCT | Other: Pre-biotic foods/drinks<br>* 2 servings per day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hematopoietic stem cell transplant, stem cell transplant, bone marrow transplant, GI microbiome