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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04629430
Recruitment Status : Recruiting
First Posted : November 16, 2020
Last Update Posted : August 20, 2021
Information provided by (Responsible Party):
Indumathy Varadarajan, MD, 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.

Condition or disease Intervention/treatment Phase
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 Other: Pre-biotic foods/drinks Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 29 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Prebiotics on Gut Microbiome in Patients Undergoing Stem Cell Transplants
Actual Study Start Date : February 19, 2021
Estimated Primary Completion Date : March 1, 2023
Estimated Study Completion Date : March 1, 2024

Arm Intervention/treatment
Experimental: Prebiotic diet
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
2 servings per day

Primary Outcome Measures :
  1. Frequency of participants ingesting the required diet [ Time Frame: 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 Outcome Measures :
  1. Incidence and severity of acute GVHD (aGVHD) and acute GI GVHD [ Time Frame: Within the first 100 days following HSCT ]
    Stage and grade of aGVHD (allogeneic HSCT participants only)

  2. Incidence of CDiff infection [ Time Frame: Within the first 100 days following HSCT ]
    Number of people diagnosed with CDiff during the time frame

  3. Patient weight [ Time Frame: From initiation of conditioning regimen for HSCT through 100 days following HSCT ]
  4. Number of days to neutrophil engraftment [ Time Frame: 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04629430

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Contact: Gianna Strand 434 243 6377
Contact: Danyelle Coley (434) 982-5027

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United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22903
Contact: Gianna Strand    434-243-6377   
Sponsors and Collaborators
University of Virginia
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Principal Investigator: Indumathy Varadarajan Assistant Professor
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Responsible Party: Indumathy Varadarajan, MD, Assistant Professor, University of Virginia Identifier: NCT04629430    
Other Study ID Numbers: HSR 200296
First Posted: November 16, 2020    Key Record Dates
Last Update Posted: August 20, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Indumathy Varadarajan, MD, University of Virginia:
hematopoietic stem cell transplant
stem cell transplant
bone marrow transplant
GI microbiome
Additional relevant MeSH terms:
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Multiple Myeloma
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Hodgkin Disease
Lymphoma, Mantle-Cell
Myelodysplastic Syndromes
Anemia, Sickle Cell
Myeloproliferative Disorders
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms, Plasma Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Bone Marrow Diseases
Lymphoma, Non-Hodgkin
Leukemia, Lymphoid
Anemia, Hemolytic, Congenital
Anemia, Hemolytic