Autologous TransplantNCT04685525
Mycobiome Supporting Diet to Reduce GI Toxicity Associated With ASCT
A study testing Mycobiome Supporting Diet in people with Autologous Transplant and Myeloma, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to determine if this specific Mycobiome Supporting Diet (MSD diet) can help reduce gut inflammation during post-transplant period. The MSD is an special diet which will be explained in detail by a dietician that works by supporting the body's good gut bacteria and fungi. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autologous Transplant, Myeloma
- What is being tested?
- Mycobiome Supporting Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible for first autologous transplant for myeloma
- Willing to adhere to the allowed and disallowed foods of the diet plan.
- Able to get and prepare their own food items for all meals during the study
Who cannot join
- Active inflammatory bowel disease, celiac disease, other chronic intestinal disorders
- Pregnant women, planning to get pregnant or breastfeeding
- Prior bowel resection
- Inability to tolerate the study diet due to allergies/ intolerance/ preference
- Inability to consent to trial
- Patients with restrictions in diet including inability to have oral nutrition with regular consistency
Show all 10Show fewer
- Any condition that the investigator feels may limit the volunteer's ability to complete the study protocol.
- Patients with absolute neutrophil count (ANC) < 1000 on long term antibacterial prophylaxis ongoing 3 days prior to enrollment
- Patients who received antifungal therapy in 3 days prior to enrollment
- Patients who received steroid therapy in 7 days prior to enrollment
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
About this study
Official title: Mycobiome Supporting Diet (MSD) to Reduce Gastrointestinal (GI) Toxicity Associated With Autologous Stem Cell Transplant (ASCT) For Patients With Multiple Myeloma (MM)
The purpose of this study is to determine if this specific Mycobiome Supporting Diet (MSD diet) can help reduce gut inflammation during post-transplant period. The MSD is an special diet which will be explained in detail by a dietician that works by supporting the body's good gut bacteria and fungi.
Read the detailed description
This is a non-randomized cohort study. Participants will be on a specific diet for 4 weeks prior to transplant and 10 days after transplant, and will then be asked to fill out several questionnaires during this period to see if this diet is easy and simple to follow. The questionnaires will be weekly while participants are outpatient and once admitted to the hospital, participants will need to fill it on the last day (10 days after stem cell infusion). Participants will also be requested to provide fecal swab samples which we will test for bacteria and fungi. A total of 3 samples will be taken at different time points during this study.
- Conditions
- Autologous Transplant, Myeloma
- Being tested
- Mycobiome Supporting Diet
- Medical subject headings
- Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mycobiome Supporting DietBehavioural
MSD takes combines elements from several diets (e.g., Paleo, low-carbohydrate, vegetarian, and Mediterranean) and excludes elements of these diets that have been specifically proven to increase pathogenic fungi in the human gut.
| Study group | Role | What they receive |
|---|---|---|
| Mycobiome Supporting Diet | Experimental | 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 Receives: Behavioral: Mycobiome Supporting Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of participants with at least 2 out of 3 assessments marked "more than half the time" on compliance questionnaire
MSD adherence feasibility measured by percent of participants with at least 2 out of 3 assessments marked "more than half the time" on compliance questionnaire. The questionnaire includes a multiple choice questions about adherence to diet (4 levels, from 'not at all' to 'the whole time'), a multiple choice question identifying barriers to adherence, and 8 yes/no questions about medication use and symptom experience. The MSD diet will deem feasible if at least 80 percent of participants showed adherence defined by 2 out of 3 assessment marked "more than half the time".
Measured: 21 days prior to Transplant (an average of 1 month from start of study)
Percent of participants with at least 2 out of 3 assessments marked "more than half the time" on compliance questionnaire
MSD adherence feasibility measured by percent of participants with at least 2 out of 3 assessments marked "more than half the time" on compliance questionnaire. The questionnaire includes a multiple choice questions about adherence to diet (4 levels, from 'not at all' to 'the whole time'), a multiple choice question identifying barriers to adherence, and 8 yes/no questions about medication use and symptom experience. The MSD diet will deem feasible if at least 80 percent of participants showed adherence defined by 2 out of 3 assessment marked "more than half the time".
Measured: 14 days prior to transplant (an average of 1 month from start of study)
Percent of participants with at least 2 out of 3 assessments marked "more than half the time" on compliance questionnaire
MSD adherence feasibility measured by percent of participants with at least 2 out of 3 assessments marked "more than half the time" on compliance questionnaire. The questionnaire includes a multiple choice questions about adherence to diet (4 levels, from 'not at all' to 'the whole time'), a multiple choice question identifying barriers to adherence, and 8 yes/no questions about medication use and symptom experience. The MSD diet will deem feasible if at least 80 percent of participants showed adherence defined by 2 out of 3 assessment marked "more than half the time".
Measured: 7 days prior to transplant (an average of 1 month from start of study)
Patient-reported outcome (PRO)-Common Terminology Criteria for Adverse Even CTCAE questionnaire
Patient perception of symptoms measured using PRO-CTCAE questionnaire, consisting of 15 questions with frequency and severity scores, questions ranging 1 to 5, 5 is worse and 1 is less
Measured: After baseline (7 days post-transplant)
PRO-CTCAE questionnaire scores
Patient perception of symptoms measured using PRO-CTCAE questionnaire, consisting of 15 questions with frequency and severity scores, questions ranging 1 to 5, 5 is worse and 1 is less
Measured: week 1 in the 1 month prior to transplant
PRO-CTCAE questionnaire scores
Patient perception of symptoms measured using PRO-CTCAE questionnaire, consisting of 15 questions with frequency and severity scores, questions ranging 1 to 5, 5 is worse and 1 is less
Measured: week 2 in the 1 month prior to transplant
PRO-CTCAE questionnaire scores
Patient perception of symptoms measured using PRO-CTCAE questionnaire, consisting of 15 questions with frequency and severity scores, questions ranging 1 to 5, 5 is worse and 1 is less
Measured: week 3 in the 1 month prior to transplant
PRO-CTCAE questionnaire scores
Patient perception of symptoms measured using PRO-CTCAE questionnaire, consisting of 15 questions with frequency and severity scores, questions ranging 1 to 5, 5 is worse and 1 is less
Measured: week 4 in the 1 month prior to transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2020
- Study start1 Apr 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Why it stopped: Administrative decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autologous TransplantStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ehsan Malek, MD, Principal investigator, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04685525
- Sponsor's protocol ID
- CASE12Z20
- Status last verified
- Apr 2024
- First submitted
- 22 Dec 2020
- Last updated
- 26 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared due to the small sample size of the study participants in order to protect their identities.
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mycobiome Supporting Diet (MSD) to Reduce Gastrointestinal (GI) Toxicity Associated With Autologous Stem Cell Transplant (ASCT) For Patients With Multiple Myeloma (MM)
- ClinicalTrials.gov ID
- NCT04685525
- Acronym / sponsor ID
- CASE12Z20
- Conditions
- Autologous Transplant, Myeloma
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Administrative decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 28 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if this specific Mycobiome Supporting Diet (MSD diet) can help reduce gut inflammation during post-transplant period. The MSD is an special diet which will be explained in detail by a dietician that works by supporting the body's good gut bacteria and fungi.
Detailed description
This is a non-randomized cohort study. Participants will be on a specific diet for 4 weeks prior to transplant and 10 days after transplant, and will then be asked to fill out several questionnaires during this period to see if this diet is easy and simple to follow. The questionnaires will be weekly while participants are outpatient and once admitted to the hospital, participants will need to fill it on the last day (10 days after stem cell infusion). Participants will also be requested to provide fecal swab samples which we will test for bacteria and fungi. A total of 3 samples will be taken at different time points during this study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mycobiome Supporting Diet | Experimental | Behavioral: Mycobiome Supporting DietParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Eligible for first autologous transplant for myeloma
- Willing to adhere to the allowed and disallowed foods of the diet plan.
- Able to get and prepare their own food items for all meals during the study
Key exclusion criteria (10 listed)
- Active inflammatory bowel disease, celiac disease, other chronic intestinal disorders
- Pregnant women, planning to get pregnant or breastfeeding
- Prior bowel resection
- Inability to tolerate the study diet due to allergies/ intolerance/ preference
- Inability to consent to trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mycobiome Supporting DietMSD takes combines elements from several diets (e.g., Paleo, low-carbohydrate, vegetarian, and Mediterranean) and excludes elements of these diets that have been specifically proven to increase pathogenic fungi in the human gut. | Behavioural | Mycobiome Supporting Diet |
Primary outcome
Percent of participants with at least 2 out of 3 assessments marked "more than half the time" on compliance questionnaire
Time frame: 21 days prior to Transplant (an average of 1 month from start of study)
MSD adherence feasibility measured by percent of participants with at least 2 out of 3 assessments marked "more than half the time" on compliance questionnaire. The questionnaire includes a multiple choice questions about adherence to diet (4 levels, from 'not at all' to 'the whole time'), a multiple choice question identifying barriers to adherence, and 8 yes/no questions about medication use and symptom experience. The MSD diet will deem feasible if at least 80 percent of participants showed adherence defined by 2 out of 3 assessment marked "more than half the time".
Percent of participants with at least 2 out of 3 assessments marked "more than half the time" on compliance questionnaire
Time frame: 14 days prior to transplant (an average of 1 month from start of study)
MSD adherence feasibility measured by percent of participants with at least 2 out of 3 assessments marked "more than half the time" on compliance questionnaire. The questionnaire includes a multiple choice questions about adherence to diet (4 levels, from 'not at all' to 'the whole time'), a multiple choice question identifying barriers to adherence, and 8 yes/no questions about medication use and symptom experience. The MSD diet will deem feasible if at least 80 percent of participants showed adherence defined by 2 out of 3 assessment marked "more than half the time".
Percent of participants with at least 2 out of 3 assessments marked "more than half the time" on compliance questionnaire
Time frame: 7 days prior to transplant (an average of 1 month from start of study)
MSD adherence feasibility measured by percent of participants with at least 2 out of 3 assessments marked "more than half the time" on compliance questionnaire. The questionnaire includes a multiple choice questions about adherence to diet (4 levels, from 'not at all' to 'the whole time'), a multiple choice question identifying barriers to adherence, and 8 yes/no questions about medication use and symptom experience. The MSD diet will deem feasible if at least 80 percent of participants showed adherence defined by 2 out of 3 assessment marked "more than half the time".
Patient-reported outcome (PRO)-Common Terminology Criteria for Adverse Even CTCAE questionnaire
Time frame: After baseline (7 days post-transplant)
Patient perception of symptoms measured using PRO-CTCAE questionnaire, consisting of 15 questions with frequency and severity scores, questions ranging 1 to 5, 5 is worse and 1 is less
PRO-CTCAE questionnaire scores
Time frame: week 1 in the 1 month prior to transplant
Patient perception of symptoms measured using PRO-CTCAE questionnaire, consisting of 15 questions with frequency and severity scores, questions ranging 1 to 5, 5 is worse and 1 is less
PRO-CTCAE questionnaire scores
Time frame: week 2 in the 1 month prior to transplant
Patient perception of symptoms measured using PRO-CTCAE questionnaire, consisting of 15 questions with frequency and severity scores, questions ranging 1 to 5, 5 is worse and 1 is less
PRO-CTCAE questionnaire scores
Time frame: week 3 in the 1 month prior to transplant
Patient perception of symptoms measured using PRO-CTCAE questionnaire, consisting of 15 questions with frequency and severity scores, questions ranging 1 to 5, 5 is worse and 1 is less
PRO-CTCAE questionnaire scores
Time frame: week 4 in the 1 month prior to transplant
Patient perception of symptoms measured using PRO-CTCAE questionnaire, consisting of 15 questions with frequency and severity scores, questions ranging 1 to 5, 5 is worse and 1 is less
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
- Individual participant dataSharing planned: No. IPD will not be shared due to the small sample size of the study participants in order to protect their identities.
Related trials for Autologous Transplant
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Recruiting
NIRAF-Guided Parathyroid Identification During Thyroidectomy
Hypocalcemia, Hypoparathyroidism
Not yet recruiting
Autologous Thymus Transplant in Children With Congenital Heart Disease: A Pilot Study
Congenital Heart Disease (CHD)
Not yet recruiting
Free Soft Tissue Grafts (FSTG) Using Autograft Palatal Donor Tissue vs. Xenograft Collagen Matrix (Zderm™)
Gingival Recession Localized Moderate, Dental Implant
Active, not recruitingPhase 2
Siltuximab to Decrease Symptom Burden After Autologous Stem Cell Transplantation for Patients With Multiple Myeloma and AL Amyloidosis
Multiple Myeloma, AL Amyloidosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ehsan Malek, MD principal investigator
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mycobiome Supporting Diet in people with Autologous Transplant and Myeloma, run by Case Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of participants with at least 2 out of 3 assessments marked "more than half the time" on compliance questionnaire (time frame: 21 days prior to Transplant (an average of 1 month from start of study)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2024.