Mycobiome Supporting Diet to Reduce GI Toxicity Associated With ASCT

NCT ID: NCT04685525

Last Updated: 2024-04-26

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2025-06-30

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.

Conditions

Autologous Transplant; Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Mycobiome Supporting Diet

Intervention Type: BEHAVIORAL

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.

Interventions

Mycobiome Supporting Diet

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Case Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ehsan Malek, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Locations

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

CASE12Z20

Identifier Type: -

Identifier Source: org_study_id