Study Using Prebiotics to Improve Gut Microbiome Diversity After Autologous Cellular Therapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorUniversity of Nebraska
About this trial
Higher gut microbiome diversity has been associated with improved survival following autologous stem cell transplantation in multiple myeloma and lymphoma. This study hypothesises that prebiotic supplementation with resistant starch (RS) will improve gut microbiome diversity at time of stem cell engraftment. To test this, participants will either have RS or a placebo (maltodextrin) mixed into a food item of their choice for approximately 10 days prior to stem cell infusion and continue to the first day of neutrophil engraftment. The study will look at the difference in gut microbiome diversity between the RS and placebo arm collected at the engraftment timepoint, dietary evaluation to assess the impact of subject diet on microbiome response to intervention and serum sample collection to assess differences to gut permeability during transplant.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Willing to provide informed consent
Willing to comply with all study procedures and be available for the duration of the study
Has pathologically confirmed multiple myeloma, Non-Hodgkin lymphoma (DLBCL, mantle cell lymphoma, follicular lymphoma, or peripheral T-cell lymphoma), or Hodgkin lymphoma as determined on medical record review per standard of care transplant procedures (no tissue required for study)
Meeting a standard-of-care indication for autologous stem cell transplantation for the above diseases as determined by the investigator
Disqualifiers
History of bariatric surgery (i.e. gastric banding, sleeve gastrectomy, Roux-en-Y bypass), chronic gastrointestinal disease including chronic diarrheal illness or inflammatory bowel disease
Previous intolerance to fiber supplementation
Allergy or intolerance to potato starch or maltodextrin
Subject unwilling to comply with stool sample collection
Trial design
Design model
Parallel
Treatments tested in this trial
Resistant Starch
Dietary supplementA prebiotic nutritional supplement available at commercial grocery and health food stores. Specifically, we will be using Bob's Red Mill® potato starch.
Maltodextrin
Dietary supplementA starch commonly used as a placebo in prebiotic trials that is digested in the stomach and rapidly absorbed
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: TreatmentExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of subjects who adhere to >70% of scheduled doses of the intervention
To understand the feasibility of the intervention in the proposed study population, the percentage of subjects who adhere to \>70% of scheduled doses will be calculated
Time frame
35 DaysSecondary outcomes
1
Hospital Duration
To evaluate the duration of hospitalization according to intervention assignment by measuring time from stem cell transplant to day of discharge.
Time frame
25 days2
Rate of Neutropenic Fever
To estimate the rate of neutropenic fever in the post-transplant setting according to intervention assignment. This is captured by cumulative incidence of neutropenic fever (ANC \<1000, temperature \>38.0⁰C) by day 30 according to intervention assignment
Time frame
25 Days3
Rate of broad-spectrum antibiotic exposure
To determine the rate of broad-spectrum antibiotic exposure during transplant according to intervention assignment by measuring the proportion of subjects receiving systemic antibiotic exposure.
Time frame
25 Days4
Rate of gastrointestinal symptoms
To determine the rate of gastrointestinal symptoms according to intervention assignment by using the patient-reported gastrointestinal symptom rating scale (GSRS.)
Time frame
35 DaysSponsors and contacts
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Source ClinicalTrials.gov