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

January 2, 2023 updated by: Indumathy Varadarajan, MD, University of Virginia

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • University of Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Time Frame: Within the first 100 days following HSCT
Stage and grade of aGVHD (allogeneic HSCT participants only)
Within the first 100 days following HSCT
Incidence of CDiff infection
Time Frame: Within the first 100 days following HSCT
Number of people diagnosed with CDiff during the time frame
Within the first 100 days following HSCT
Patient weight
Time Frame: From initiation of conditioning regimen for HSCT through 100 days following HSCT
From initiation of conditioning regimen for HSCT through 100 days following HSCT
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
From initiation of conditioning regimen for HSCT through 100 days following HSCT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Investigators

  • Principal Investigator: Indumathy Varadarajan, Assistant Professor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 19, 2021

Primary Completion (Actual)

October 28, 2022

Study Completion (Actual)

October 28, 2022

Study Registration Dates

First Submitted

November 10, 2020

First Submitted That Met QC Criteria

November 10, 2020

First Posted (Actual)

November 16, 2020

Study Record Updates

Last Update Posted (Actual)

January 4, 2023

Last Update Submitted That Met QC Criteria

January 2, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSR 200296

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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