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Effects of Prebiotics on Gut Microbiome in Patients Undergoing HSCT

Not Applicable
Completed
Conditions
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Acute Lymphocytic Leukemia
Hodgkin Disease
Myelodysplastic Syndromes
Multiple Myeloma
Non Hodgkin Lymphoma
Myelofibrosis
Sickle Cell Disease
Mantle Cell Lymphoma
Interventions
Other: Pre-biotic foods/drinks
Registration Number
NCT04629430
Lead Sponsor
University of Virginia
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
40
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Prebiotic dietPre-biotic foods/drinks2 servings a day of pre-biotics every day from start of conditioning regimen for HSCT through 100 days following HSCT
Primary Outcome Measures
NameTimeMethod
Frequency of participants ingesting the required dietFrom 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 Outcome Measures
NameTimeMethod
Incidence and severity of acute GVHD (aGVHD) and acute GI GVHDWithin the first 100 days following HSCT

Stage and grade of aGVHD (allogeneic HSCT participants only)

Incidence of CDiff infectionWithin the first 100 days following HSCT

Number of people diagnosed with CDiff during the time frame

Number of days to neutrophil engraftmentFrom initiation of conditioning regimen for HSCT through 100 days following HSCT

Absolute neutrophil count \>1000 for 1 day or \> 500 for 3 consecutive days

Patient weightFrom initiation of conditioning regimen for HSCT through 100 days following HSCT

Trial Locations

Locations (1)

University of Virginia

🇺🇸

Charlottesville, Virginia, United States

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