Effects of Prebiotics on Gut Microbiome in Patients Undergoing Stem Cell Transplants
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Virginia
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Frequency of participants ingesting the required diet
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Prebiotic diet
2 servings a day of pre-biotics every day from start of conditioning regimen for HSCT through 100 days following HSCT
Intervention: Pre-biotic foods/drinks (Other)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- 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)
- Number of days to neutrophil engraftment(From initiation of conditioning regimen for HSCT through 100 days following HSCT)
- Patient weight(From initiation of conditioning regimen for HSCT through 100 days following HSCT)
Investigators
Indumathy Varadarajan, MD
Assistant Professor
University of Virginia