HCTDiet: Effects of Prebiotics on Gut Microbiome in Patients Undergoing HSCT

Sponsor

University of Virginia (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04629430

Collaborator

(none)

Enrollment

Location

Arm

36.3

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

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.

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	N/A

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 Design

Study Type:

Interventional

Anticipated 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 :

Feb 19, 2021

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Mar 1, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Frequency of participants ingesting the required diet [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

Incidence and severity of acute GVHD (aGVHD) and acute GI GVHD [Within the first 100 days following HSCT]
Stage and grade of aGVHD (allogeneic HSCT participants only)
Incidence of CDiff infection [Within the first 100 days following HSCT]
Number of people diagnosed with CDiff during the time frame
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]
Absolute neutrophil count >1000 for 1 day or > 500 for 3 consecutive days

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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