Mycobiome Supporting Diet to Reduce GI Toxicity Associated With ASCT

Not Applicable

Withdrawn

• Conditions: Autologous Transplant; Myeloma
• Interventions: Behavioral: Mycobiome Supporting Diet

• Registration Number: NCT04685525
• Lead Sponsor: Case Comprehensive Cancer Center

Brief 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.

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 Timeline

• Study First Submitted: 2020-12-22
• Study First Submitted QC: 2020-12-22
• Study First Posted: 2020-12-28
• Status Verified: 2024-04
• Study Start: 2024-04-01
• Last Update Submitted: 2024-04-25
• Last Update Posted: 2024-04-26
• Primary Completion: 2024-12-31
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mycobiome Supporting Diet	Mycobiome Supporting Diet	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

Primary Outcome Measures

Name	Time	Method
Percent of participants with at least 2 out of 3 assessments marked "more than half the time" on compliance questionnaire	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	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	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

Trial Locations

Locations (1)

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center; 🇺🇸 Cleveland, Ohio, United States