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

Primary Purpose

Multiple Myeloma, Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pre-biotic foods/drinks
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring hematopoietic stem cell transplant, stem cell transplant, bone marrow transplant, GI microbiome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Virginia

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Prebiotic diet

Arm Description

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

Outcomes

Primary Outcome Measures

Frequency of participants ingesting the required diet
Frequency of participants reporting ingesting at least 2 servings of prebiotics on ≥ 80% of study days

Secondary Outcome Measures

Incidence and severity of acute GVHD (aGVHD) and acute GI GVHD
Stage and grade of aGVHD (allogeneic HSCT participants only)
Incidence of CDiff infection
Number of people diagnosed with CDiff during the time frame
Patient weight
Number of days to neutrophil engraftment
Absolute neutrophil count >1000 for 1 day or > 500 for 3 consecutive days

Full Information

First Posted
November 10, 2020
Last Updated
January 2, 2023
Sponsor
University of Virginia
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1. Study Identification

Unique Protocol Identification Number
NCT04629430
Brief Title
Effects of Prebiotics on Gut Microbiome in Patients Undergoing HSCT
Acronym
HCTDiet
Official Title
Effects of Prebiotics on Gut Microbiome in Patients Undergoing Stem Cell Transplants
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
February 19, 2021 (Actual)
Primary Completion Date
October 28, 2022 (Actual)
Study Completion Date
October 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
hematopoietic stem cell transplant, stem cell transplant, bone marrow transplant, GI microbiome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prebiotic diet
Arm Type
Experimental
Arm Description
2 servings a day of pre-biotics every day from start of conditioning regimen for HSCT through 100 days following HSCT
Intervention Type
Other
Intervention Name(s)
Pre-biotic foods/drinks
Intervention Description
2 servings per day
Primary Outcome Measure Information:
Title
Frequency of participants ingesting the required diet
Description
Frequency of participants reporting ingesting at least 2 servings of prebiotics on ≥ 80% of study days
Time Frame
From initiation of conditioning regimen for HSCT through 100 days following HSCT
Secondary Outcome Measure Information:
Title
Incidence and severity of acute GVHD (aGVHD) and acute GI GVHD
Description
Stage and grade of aGVHD (allogeneic HSCT participants only)
Time Frame
Within the first 100 days following HSCT
Title
Incidence of CDiff infection
Description
Number of people diagnosed with CDiff during the time frame
Time Frame
Within the first 100 days following HSCT
Title
Patient weight
Time Frame
From initiation of conditioning regimen for HSCT through 100 days following HSCT
Title
Number of days to neutrophil engraftment
Description
Absolute neutrophil count >1000 for 1 day or > 500 for 3 consecutive days
Time Frame
From initiation of conditioning regimen for HSCT through 100 days following HSCT

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Indumathy Varadarajan
Organizational Affiliation
Assistant Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effects of Prebiotics on Gut Microbiome in Patients Undergoing HSCT

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