Effects of Prebiotics on Gut Microbiome in Patients Undergoing HSCT

NCT ID: NCT04629430

Last Updated: 2023-01-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-19
• Study Completion Date: 2022-10-28

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Prebiotic diet

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

Group Type: EXPERIMENTAL

Pre-biotic foods/drinks

Intervention Type: OTHER

2 servings per day

Interventions

Pre-biotic foods/drinks

2 servings per day

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

Indumathy Varadarajan, MD

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Indumathy Varadarajan

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor

Locations

University of Virginia

Charlottesville, Virginia, United States

Countries

United States

Other Identifiers

HSR 200296

Identifier Type: -

Identifier Source: org_study_id