Clinical trial · Interventional
Mycobiome Supporting Diet to Reduce GI Toxicity Associated With ASCT
Mycobiome Supporting Diet (MSD) to Reduce Gastrointestinal (GI) Toxicity Associated With Autologous Stem Cell Transplant (ASCT) For Patients With Multiple Myeloma (MM)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Administrative decision
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Autologous Transplant | — | UNRESOLVED | — |
| Myeloma | Multiple Myeloma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mycobiome Supporting Diet | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Mycobiome Supporting Diet
- description
- 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
- interventionNames
- Behavioral: Mycobiome Supporting Diet
Primary outcomes (8)
- measure
- Percent of participants with at least 2 out of 3 assessments marked "more than half the time" on compliance questionnaire
- timeFrame
- 21 days prior to Transplant (an average of 1 month from start of study)
- description
- 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".
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available