NCT04629430

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable multiple-myeloma

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable multiple-myeloma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 10, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 16, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

February 19, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 28, 2022

Completed
Last Updated

January 4, 2023

Status Verified

January 1, 2023

Enrollment Period

1.7 years

First QC Date

November 10, 2020

Last Update Submit

January 2, 2023

Conditions

Multiple MyelomaAcute Myeloid LeukemiaAcute Lymphoblastic LeukemiaNon Hodgkin LymphomaAcute Lymphocytic LeukemiaHodgkin LymphomaHodgkin DiseaseMyelofibrosisMyelodysplastic SyndromesMyeloproliferative NeoplasmSickle Cell DiseaseMantle Cell Lymphoma

Keywords

hematopoietic stem cell transplantstem cell transplantbone marrow transplantGI microbiome

Outcome Measures

Primary Outcomes (1)

  • Frequency of participants ingesting the required diet

    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 Outcomes (4)

  • Incidence and severity of acute GVHD (aGVHD) and acute GI GVHD

    Within the first 100 days following HSCT

  • Incidence of CDiff infection

    Within the first 100 days following HSCT

  • Patient weight

    From initiation of conditioning regimen for HSCT through 100 days following HSCT

  • Number of days to neutrophil engraftment

    From initiation of conditioning regimen for HSCT through 100 days following HSCT

Study Arms (1)

Prebiotic diet

EXPERIMENTAL

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

Interventions

Pre-biotic foods/drinksOTHER

2 servings per day

Prebiotic diet

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

MeSH Terms

Conditions

Multiple MyelomaLeukemia, Myeloid, AcutePrecursor Cell Lymphoblastic Leukemia-LymphomaLymphoma, Non-HodgkinHodgkin DiseasePrimary MyelofibrosisMyelodysplastic SyndromesMyeloproliferative DisordersAnemia, Sickle CellLymphoma, Mantle-Cell

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesLeukemia, MyeloidLeukemiaLeukemia, LymphoidLymphatic DiseasesLymphomaBone Marrow DiseasesAnemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Indumathy Varadarajan

    Assistant Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 10, 2020

First Posted

November 16, 2020

Study Start

February 19, 2021

Primary Completion

October 28, 2022

Study Completion

October 28, 2022

Last Updated

January 4, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)