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Prebiotic

Prebiotics for Multiple Myeloma

N/A
Recruiting
Led By Christopher R D'Angelo, MD
Research Sponsored by University of Nebraska
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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)
Adult Individuals (male or female) at least 19 years of age
Must not have
Subject unwilling to comply with stool sample collection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 35 days

Summary

This trial will test whether prebiotic supplementation with resistant starch can improve gut microbiome diversity at time of stem cell engraftment in patients with myeloma or lymphoma.

Who is the study for?
This trial is for adults over 19 with multiple myeloma or certain types of lymphoma who are about to have their first stem cell transplant. They must be willing to follow the study rules and provide informed consent. People can't join if they've had issues with fiber supplements, won't give stool samples, have a history of major gut surgery or chronic gut diseases, or allergies to potato starch or maltodextrin.
What is being tested?
The study tests whether adding resistant starch (RS) to food improves gut microbiome diversity in patients receiving stem cell transplants compared to a placebo (maltodextrin). Participants will consume RS or placebo from around 10 days before until the day their new white blood cells start growing after the transplant.
What are the potential side effects?
Potential side effects may include digestive discomfort due to prebiotic intake such as bloating, gas, constipation, or diarrhea. However, since this trial involves dietary supplements rather than drugs, severe side effects are less likely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with multiple myeloma, Non-Hodgkin lymphoma, or Hodgkin lymphoma.
Select...
I am 19 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am unwilling to provide stool samples for the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~35 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 35 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of subjects who adhere to >70% of scheduled doses of the intervention
Secondary study objectives
Hospital Duration
Rate of Neutropenic Fever
Antibiotics
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: TreatmentExperimental Treatment1 Intervention
resistant starch
Group II: PlaceboPlacebo Group1 Intervention
maltodextrin
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Resistant Starch
2006
N/A
~140

Find a Location

Who is running the clinical trial?

University of NebraskaLead Sponsor
555 Previous Clinical Trials
1,145,356 Total Patients Enrolled
38 Trials studying Lymphoma
1,472 Patients Enrolled for Lymphoma
Christopher R D'Angelo, MDPrincipal InvestigatorUniversity of Nebraska
1 Previous Clinical Trials
33 Total Patients Enrolled
1 Trials studying Lymphoma
33 Patients Enrolled for Lymphoma
Christopher D'Angelo, MDPrincipal InvestigatorUniversity of Nebraska
2 Previous Clinical Trials
41 Total Patients Enrolled
1 Trials studying Lymphoma
33 Patients Enrolled for Lymphoma

Media Library

Resistant Starch (Prebiotic) Clinical Trial Eligibility Overview. Trial Name: NCT05135351 — N/A
Lymphoma Research Study Groups: Treatment, Placebo
Lymphoma Clinical Trial 2023: Resistant Starch Highlights & Side Effects. Trial Name: NCT05135351 — N/A
Resistant Starch (Prebiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05135351 — N/A
~11 spots leftby Jul 2026
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