Non Hodgkin Lymphoma Clinical Trial

Effects of Prebiotics on Gut Microbiome in Patients Undergoing HSCT

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.

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Full 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.

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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

Study is for people with:

Non Hodgkin Lymphoma

Estimated Enrollment:

29

Study ID:

NCT04629430

Recruitment Status:

Active, not recruiting

Sponsor:

University of Virginia

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There is 1 Location for this study

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University of Virginia
Charlottesville Virginia, 22903, United States

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Study is for people with:

Non Hodgkin Lymphoma

Estimated Enrollment:

29

Study ID:

NCT04629430

Recruitment Status:

Active, not recruiting

Sponsor:


University of Virginia

How clear is this clinincal trial information?

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