Duke University Medical Center
Durham, North Carolina, 27710, United States
NCT Number: NCT01687231
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.
Looking for future studies?
Notify Me20 year–70 year
All sexes
Interventional
Not applicable
Durham, North Carolina, 27710, United States
In the proposed pilot study, a randomized design will be used to address the primary and secondary aims. Subjects will be randomized to either the experimental group receiving a non-neutropenic diet without restriction, or to the control group receiving the standard neutropenic diet. While randomization will occur prior to, or on the day of their inpatient admission and the subjects will begin study procedures upon admission to the Adult Stem Cell Transplant Inpatient Unit at Duke University Medical Center.
The diet will continue until 1) the subject is no longer neutropenic, and/or 2) discharged from the inpatient unit to continue their care in the Adult Stem Cell Transplant Outpatient Clinic. By limiting the study to the time of care on the inpatient unit, we will minimize the opportunity for deviation from the assigned diet. Absence of neutropenia will be defined as an absolute neutrophil count of greater than 500/uL (manual differential) and a total white blood cell count of 1000/uL for three consecutive days.
All subjects enrolled will follow the standard prophylactic antibiotic regimen. Other supportive care will also be consistent in the two groups.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Non-neutropenic diet is without restriction.
Time frame: Duration of hospitalization or neutropenia, an expected average of 5 weeks.
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.
Time frame: Duration of hospitalization or neutropenia, an expected average of 5 weeks.
The participants will be followed for the duration of hospital stay or until neutropenic, an expected average of 5 weeks. The time frame will 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. The nutritional status will be assessed by the Scored Patient-Generated Subjective Global Assessment (PG-SGA) platform.
Duke University
Other
A Randomized Pilot Study Comparing Infection Rates in Myeloablative Allogeneic Stem Cell Transplant Patients Receiving a Non-Neutropenic Diet or a Neutropenic Diet
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04696809
Hematologic Diseases, Hematologic Malignancies
Chiba, Japan
View Trial DetailsNCT02494258
Hematologic Diseases, Hematologic Malignancies
Gainesville, Florida, United States
View Trial DetailsNCT05433090
Hematologic Diseases, Hematologic Malignancies
Rochester, New York, United States
View Trial DetailsNCT06900114
Bacterial Infections and Mycoses, COVID-19
Tianjin, China
View Trial Details