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Dietary Intervention
Mycobiome Diet for Gut Health After Multiple Myeloma Transplant
N/A
Waitlist Available
Led By Ehsan Malek, MD
Research Sponsored by Case Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eligible for first autologous transplant for myeloma
Able to get and prepare their own food items for all meals during the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 4 in the 1 month prior to transplant
Awards & highlights
Study Summary
This trial will study if a special Mycobiome Supporting Diet can help reduce gut inflammation after a transplant.
Who is the study for?
This trial is for individuals preparing for their first autologous transplant to treat myeloma. Participants must be able to follow a special diet and prepare their own meals. It's not suitable for those with chronic intestinal disorders, pregnant or breastfeeding women, or anyone unable to consent. People on certain medications or with dietary restrictions due to allergies cannot join.Check my eligibility
What is being tested?
The study is testing whether a Mycobiome Supporting Diet (MSD), which promotes good gut bacteria and fungi, can reduce gut inflammation after an autologous transplant in myeloma patients. A dietician will guide participants through the MSD plan.See study design
What are the potential side effects?
Since this intervention involves following a specific diet rather than taking medication, side effects may include digestive changes as the body adjusts to new foods that support gut health.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am eligible for my first stem cell transplant for myeloma.
Select...
I can prepare my own meals throughout the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 4 in the 1 month prior to transplant
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 4 in the 1 month prior to transplant
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
PRO-CTCAE questionnaire scores
Patient-reported outcome (PRO)-Common Terminology Criteria for Adverse Even CTCAE questionnaire
Percent of participants with at least 2 out of 3 assessments marked "more than half the time" on compliance questionnaire
Trial Design
1Treatment groups
Experimental Treatment
Group I: Mycobiome Supporting DietExperimental Treatment1 Intervention
Participants will be able to abide by the allowed and disallowed foods in MSD diet for at least four consecutive weeks prior to conditioning and up to 10 days after transplant. Participants will maintain a diary of foods they consume and any adverse effects they are experiencing and will self- collect fecal samples 28 days before transplant, 2 days before transplant and 10 days after transplant
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Who is running the clinical trial?
Case Comprehensive Cancer CenterLead Sponsor
452 Previous Clinical Trials
31,870 Total Patients Enrolled
26 Trials studying Multiple Myeloma
1,705 Patients Enrolled for Multiple Myeloma
Ehsan Malek, MDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
5 Previous Clinical Trials
79 Total Patients Enrolled
5 Trials studying Multiple Myeloma
79 Patients Enrolled for Multiple Myeloma
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot follow the study diet because of allergies or personal preferences.My white blood cell count is low and I've been on antibiotics for it.I am unable to give consent for the trial myself.I have a chronic intestinal condition like IBD or celiac disease.I have taken antifungal medication within the last 3 days.I am eligible for my first stem cell transplant for myeloma.I have taken steroids in the week before joining this study.I can prepare my own meals throughout the study.You have difficulty eating regular food by mouth.I have had surgery to remove part of my intestine.
Research Study Groups:
This trial has the following groups:- Group 1: Mycobiome Supporting Diet
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is recruitment still open for this medical experiment?
"According to clinicaltrials.gov, this medical research is no longer taking on new participants; it was initially posted in December 1st 2022 and the most recent update being July 22nd 2022. Although the study has ended recruitment, 818 other studies are actively seeking patients at present."
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