Low Bacterial Diet in Patients With Cytopenia
The purpose of this prospective, randomized study was to determine the efficacy of low bacterial diet, in comparison to normal hospital diet, with gut colonization by aerobic Gram negative rods and yeasts as primary endpoint. In addition, the occurrence of infections and the total costs of hospital care were documented, in order to identify potential cost savings by the use of either diet.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Low Bacterial Diet in Patients With Cytopenia After Intensive Chemotherapy for Hematological Malignancy: a Study of Efficacy|
- Colonization of the gut by aerobic Gram negative rods and yeasts
- The occurrence of infections
- The total societal costs
|Estimated Study Completion Date:||June 2004|
Patients with hematological malignancies who receive intensive chemotherapy usually develop a period of cytopenia, during which there is an increased risk of infection. Mucositis can also develop in these patients, enabling micro-organisms, belonging to the endogenous intestinal flora, to translocate from the intestine to the lymphoid tissue and blood. Therefore, when mucositis and cytopenia develop simultaneously, the risk of infection increases further. In this regard bloodstream infection by Gram negative rods and yeasts are an important cause of serious infections causing considerable morbidity.
In order to reduce the risk of infection several preventive measures have been adopted. Fundamentally, all of these measures were designed to prevent either acquisition of Gram negative rods or fungal pathogens from the environment, or the translocation of these potential pathogens across the mucosal barrier of the gut. These measures include protective (or reverse) isolation, antibiotic prophylaxis with antibiotics which selectively eradicate the aerobic Gram negative rods and yeasts from the gut flora, and finally the use of low-bacterial diets.
In this prospective, randomized study on the efficacy of low bacterial diet, in comparison to normal hospital diet, gut colonization by aerobic Gram negative rods and yeasts, the occurrence of infections and the total costs of hospital care were chosen as study endpoints.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00367588
|University Hospital Maastricht|
|Maastricht, Netherlands, 6202 AZ|
|Principal Investigator:||Frank H. van Tiel, MD, PhD||University Hospital Maastricht, Maastricht, the Netherlands|