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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 35 days
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.
Select...
I am recommended for my first stem cell transplant using my own cells.
Select...
I am eligible for a stem cell transplant as per my doctor's advice.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of subjects who adhere to >70% of scheduled doses of the intervention
Secondary outcome measures
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
535 Previous Clinical Trials
1,143,876 Total Patients Enrolled
38 Trials studying Lymphoma
1,499 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are being evaluated in this clinical trial?

"The clinical trial is, as of now, looking for enrollees. The study was first made public on 4/13/2022 and was updated on 4/14/2022. They are currently 30 spots available at 1 location."

Answered by AI

Are there any openings in this trial for new participants?

"That is accurate, the website clinicaltrials.gov has information suggesting that this study is recruiting patients as we speak. This trial was first posted on April 13th, 2022 and was updated on the 14th of the same month. They are looking for a total of 30 individuals across 1 site."

Answered by AI

What are we trying to learn from this clinical trial?

"The main aim of this study, which will be measured over a period of 35 days, is to see how well participants stick to the scheduled doses of the intervention. Other outcomes that will be looked at include hospital stay (defined as the time from stem cell transplant to discharge), rate of neutropenic fever (a type of fever that can occur after a stem cell transplant), and rate of gastrointestinal symptoms."

Answered by AI
~1 spots leftby May 2024