Clinical trial · Interventional
Infection Rates of Myeloablative Allo SCT Recipients Receiving Neutropenic Diets Versus Non-Neutropenic Diets
A Randomized Pilot Study Comparing Infection Rates in Myeloablative Allogeneic Stem Cell Transplant Patients Receiving a Non-Neutropenic Diet or a Neutropenic Diet
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In the transplant community, there is debate regarding the most appropriate food services for stem cell transplant patients. Recommendations regarding the use of low bacterial diets have been based on theoretical concepts of reducing the risk of contracting infections from pathogens found in food sources rather than clinical trials. The evidence for the use of a neutropenic diet is weak. To date, there have been little to no randomized controlled studies addressing the question whether a neutropenic diet in addition to prophylactic antibiotics is necessary as infection prevention in myeloablative stem cell transplant patients. For this reason, our research is aimed at providing data to substantiate the use of neutropenic diets in preventing infections in recipients of myeloablative stem cell transplants.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematologic Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Non-neutropenic Diet | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Neutropenic Diet
- description
- This arm is the control and subjects will receive the standard of care neutropenic diet.
- type
- EXPERIMENTAL
- label
- Non-neutropenic Diet
- description
- This arm is interventional and subjects will receive a non-neutropenic diet without restriction.
- interventionNames
- Other: Non-neutropenic Diet
Primary outcomes (1)
- measure
- Incidence of Bacteremia
- timeFrame
- Duration of hospitalization or neutropenia, an expected average of 5 weeks.
- description
- Participants will be followed for the duration of hospital stay or until neutropenic, an expected average of 5 weeks. The time frame will be measured from the date of randomization until the date of discharge from the inpatient unit of the hospital or until they are assessed to be neutropenic, whichever came first, assessed up to 8 weeks.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Scheduled to undergo a myeloablative allogeneic stem cell transplant for any cancer or non-cancer illness from any related or unrelated donor source including bone marrow, peripheral blood progenitor cell, or umbilical cord blood 2. Age 20-70 years of age 3. Karnofsky Performance Scale KPS\> 80 4. Ability to read and write English Exclusion Criteria: 1. Autologous stem cell transplant recipients 2. Non-myeloablative or reduced intensity stem cell transplant recipients 3. Pregnant women 4. Patients with a documented active infection prior to starting their preparative regimen. This includes grade 3 or higher viral, bacterial, or fungal infection.
References
Publications (0)
Data not yet available