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Completed

NCT Number: NCT04629430

Effects of Prebiotics on Gut Microbiome in Patients Undergoing HSCT

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.

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Key information

Conditions

Multiple Myeloma Acute Lymphoblastic Leukemia Acute Lymphocytic Leukemia Acute Myeloid Leukemia Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Blood Protein Disorders Bone Marrow Diseases Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies Hemorrhagic Disorders Hemostatic Disorders Hodgkin Disease Hodgkin Lymphoma Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Leukemia, Myeloid Leukemia, Myeloid, Acute Lymphatic Diseases Lymphoma Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Mantle Cell Lymphoma Myelodysplastic Syndromes Myelofibrosis Myeloproliferative Disorders Myeloproliferative Neoplasm Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Non Hodgkin Lymphoma Paraproteinemias Precursor Cell Lymphoblastic Leukemia-Lymphoma Primary Myelofibrosis Sickle Cell Disease Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Virginia

Charlottesville, Virginia, 22903, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pre-biotic foods/drinks

Other

2 servings per day

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Registry information

Official study title

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

Acronym: HCTDiet

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 16, 2020
Registry last updated
Jan 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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